1. No category

Technical Assistance to Ukrainian Quality Infrastructure
Joachim Lambert
How to Export
Simple Pressure Vessels
into the European Union
-
A Guide for Manufacturers in Ukraine -
Kiev 2010
AENOR
This project was financed
by the European Union
The project was executed by a consortium of European Profiles S.A.
with AENOR, SIST and CNI
Version 2010-07-09
List of Contents
I
Foreword ........................................................................................................ 5
II
General Introduction into the whole System Established in EU in Support of
the New Approach .............................................................................................. 6
1
Introduction ................................................................................................. 6
2
The New Approach and the Global Approach ................................................ 7
3
New Approach Directives ............................................................................... 8
3.1 Simultaneous Application of Different Directives .................................................................... 8
3.2 New Approach Directives and the Directive on Product Liability .............................................. 9
4
Provisions of New Approach Directives .......................................................... 9
4.1 Placing on the Market and Putting into Service ...................................................................... 9
4.2 Responsibilities of Persons Involved in the Process of Production and Distribution of
Products .................................................................................................................................. 10
4.2.1 Manufacturer ............................................................................................................................... 10
4.2.2 Authorised Representative......................................................................................................... 11
4.2.3 Importer ..................................................................................................................................... 11
4.2.4 Assembler and Installer .............................................................................................................. 12
4.3 Essential Requirements ...................................................................................................... 12
4.4 Harmonised Standards ....................................................................................................... 13
4.5 Presumption of Conformity................................................................................................. 13
4.6 The Conformity Assessment Procedures .............................................................................. 15
4.7 Technical Documentation ................................................................................................... 15
4.8 The EC Declaration of Conformity........................................................................................ 16
4.9 The Notified Bodies ............................................................................................................ 16
4.10 CE Marking ....................................................................................................................... 17
4.11 Market Surveillance .......................................................................................................... 18
III
European Directives Regulating Pressure Equipment ................................ 21
1
Directive on Aerosol Dispensers .......................................................................................... 21
2
Pressure Equipment Directive ............................................................................................. 22
2
3
Directive on Transportable Pressure Equipment ................................................................... 23
4
Directive on Simple Pressure Vessels..................................................................................... 24
5
Directive on Appliances Burning Gaseous Fuels ..................................................................... 25
IV The Simple Pressure Vessels Directive (2009/105/EC) .............................. 26
1
The Development of Today’s Simple Pressure Vessels Directive .............................................. 26
2
The overall structure of the Simple Pressure Vessels
Directive........................................ 27
2.1 The Articles of the SPV Directive .................................................................................................... 27
2.2 The Annexes of the SPV Directive .................................................................................................. 31
V
How the Manufacturer Should Apply the SPVD ............................................ 33
1
Is the Product Covered by the SPV Directive? ........................................................................ 36
2 What requirements must be fulfilled before the SPV can be put on the market? ..................... 38
2.1 Vessels with PS x V ≤ 50 bar∙l .............................................................................................. 38
2.2 Vessels with PS x V > 50 bar∙l ............................................................................................... 38
2.2.1 Materials ..................................................................................................................................... 39
2.2.2 Vessel Design .............................................................................................................................. 41
2.2.3 The Manufacturing Process ........................................................................................................ 42
2.2.4 Putting into Service .................................................................................................................... 43
2.3 Risk Assessment .................................................................................................................. 44
2.4 Presumption of Conformity ................................................................................................. 46
2.5 Harmonised European Standards ........................................................................................ 47
2.5.1 Harmonised European Standards for Simple Pressure Vessels ................................................. 48
2.5.2 Harmonised European Standards for Simple Pressure Vessels adopted as Ukrainian
Standards ............................................................................................................................................. 50
2.6 Certification procedures ...................................................................................................... 51
2.6.1 Certification prior to production ................................................................................................ 51
2.6.1.1 The certificate of adequacy ..................................................................................................... 52
2.6.1.2 The EC type-examination ........................................................................................................ 53
2.6.2 Procedures to be applied prior to placing vessels on the market .............................................. 54
2.6.2.1 The EC verification ................................................................................................................... 54
2.6.2.2 The EC declaration of conformity ............................................................................................ 56
3
2.6.2.3 CE Marking.............................................................................................................................. 58
2.6.3
How to Find the Right Approved Inspection Body? ........................................ 59
VI Annex 1 DIRECTIVE 2009/105/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of
16 September 2009 relating to simple pressure vessels................................................................ 61
4
I
Foreword
This brochure is addressing to manufacturers of Ukraine who are planning to
export “Simple Pressure Vessels (SPV)” into the European Union or the European Economic Area. The brochure has been written in order to make manufacturers familiar with the regulations, procedures and requirements they
must obey before they can put SPV on the market of the European Union. In
chapter II of this brochure a very brief description of the elements of the “New
Approach” is given, as far as it might be of relevance for the manufacturer. In
chapter III a brief outline of the overall structure of the European Directives
regulating pressure equipment is given. This part is of importance for the
manufacturer in so far as it helps to decide, which pressure equipment is covered by which Directive and hence where SPV are regulated. In chapter IV of
the brochure a brief over all description of the Directive on Simple Pressure
vessels is given. Those parts of the Simple Pressure Vessels Directive, which
are highly relevant for the manufacturer, are described in greater detail in
chapter V. The author tried to give the necessary explanations, following the
order of the design process and the conformity assessment procedures. Where
useful the original wording of the relevant Articles and Annexes of the Directive was introduced into the chapters. The whole wording of Directive
2009/105/EC on Simple Pressure Vessels (SPVD) can be found in chapter VI,
Annex 1.
In order to keep the information up to date and keep the amount of information in certain limits, the brochure refers, where ever possible, to internet
links, where the relevant Directives, further information and further explanations can be found e.g. in the “Blue Guide on the New Approach”, the “Pressure Equipment Directive (PED) guidelines” or the “Simple pressure vessels
(SPV) Guide”. Links are also given to internet pages where the “Harmonised
European Standards“ can be found or to pages like “NANDO”, allowing the
search for notified bodies, which are to be involved in some of the conformity
assessment procedures.
In this electronic version all internet links are activated as well as the list of
contents, which is linked with the chapters in this brochure, for better
navigation.
5
II
General Introduction into the whole System
Established in EU in Support of the New Approach
The contents of this part is based on an excerpt from the European Commissions’ “Guide to the implementation of directives based on the New Approach
and the Global Approach”1, adapted to the needs of manufacturers. For more
details see the following internet link:
http://ec.europa.eu/enterprise/policies/single-market-goods/files/blue-guide/guidepublic_en.pdf
1
Introduction
Why you should establish trade relations with the European Union
This brochure is addressing to manufacturers of simple pressure vessels in
Ukraine, who are preparing to export their products to the market of the
European Union (EU).
The EU is an area in which free movement of goods is possible due to the fact,
that technical barriers to trade have been removed. The free movement of
goods is a cornerstone of the single market, created on 31 December 1992
in the European Union. If products shall be put on the European market,
whether from inside the EU or from third countries, they must be in
compliance with the essential requirements and must have passed all
conformity assessment procedures laid down for this product group in
European Directives. If products are in compliance with those requirements,
relevant for the European Union, they fulfil at the same time the requirements
for the European Economic Area (EEA), which includes, in addition to the
27 EU member states of the EU, Iceland, Liechtenstein and Norway. Exporting
products into the EEA means to enter into a market of some 505 Million
consumers, contributing more than 30% to the Gross World Product (GWP).
With 4 Member States of the EU having common borders with Ukraine, the EU
respectively the EEA is a natural trade partner for Ukraine.
In a first part this brochure will explain the principles of the new regulatory
technique and will describe the infrastructure which had to be developed in
support of the New Approach, as far as it is of relevance for the export of
products into the EEA. In the following parts the Directive 2009/105/EC for
Simple Pressure Vessels (SPV) and its application will be explained. A specific
focus will be put on those elements of the Directive, which are of relevance for
the manufacturer of SPV.
1
Guide to the implementation of directives based on the New Approach and the Global Approach
Luxembourg: Office for Official Publications of the European Communities, 2000, ISBN 92-828-7500-8
6
2
The New Approach and the Global Approach
Some background information for you, if you want to export products
to the European Union or the European Economic Area
The creation of a single market by 31 December 1992 could only be achieved
with a new regulatory technique, which was laid down by the Council Resolution of 1985 on the New Approach to technical harmonisation and standardisation2. This new regulatory technique was developed in order to eliminate technical barriers to trade in the European Union, caused by the existence of different national technical regulations and technical standards in the
member states.
In addition to the principles of the New Approach, conditions for reliable conformity assessment were necessary and with the Council Resolution of 1989
on the Global Approach to certification and testing3 a modular approach,
which subdivided conformity assessment into a number of operations (modules) was introduced. The Global Approach was accomplished by Council Decision 90/683/EEC concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical
harmonisation directives. This Decision was replaced by Decision 93/465/EEC
concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonisation directives. In addition the rules for the affixing and use of the CE conformity marking were given in this Decision4.
The New Approach was revised with a new legislative framework the so
called “goods package”, see following internet links:

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July
2008 setting out the requirements for accreditation and market surveillance relating to the
marketing of products and repealing Regulation (EEC) No 339/93

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on
a common framework for the marketing of products, and repealing Council Decision
93/465/EEC

Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July
2008 laying down procedures relating to the application of certain national technical rules
to products lawfully marketed in another Member State and repealing Decision No
3052/95/EC
It is important to know, that these Decisions address to the legislator and not
to the manufacturer. The manufacturer will find all details he must observe in
2
Council Resolution of 7 May 1985 setting out a new approach to technical harmonisation and to standardisation, Official Journal C 136, 4/6/1985
3
Global approach to certification and testing, Official Journal C 267, 19/10/1989
4
Council Decision of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to
be used in the technical harmonization directives, Official Journal L 220 , 30/08/1993
7
the Directives, respectively in the national legislation transposing these Directives, relevant for the products in question.
3
New Approach Directives
What you should know about New Approach Directives developed for
the single market in the European Union and the European Economic
Area
On the basis of the New Approach and the Global Approach, the New Approach
Directives were developed or existing Directives were revised. In the harmonisation Directives the following principles are applied:




Legislative harmonisation is limited to essential requirements that products must meet if they are placed on the Community market.
The detailed technical specifications of products, putting the essential requirements in concrete terms, are laid down in harmonised standards,
the reference numbers of which have been published in the “Official Journal
of the European Union”.
Application of harmonised standards remains voluntary and manufacturers are free to choose any other technical solution that provides compliance with the essential requirements.
But products manufactured in compliance with harmonised standards benefit from the presumption of conformity with the corresponding essential
requirements of the Directives.
New Approach directives are addressed to the Member States, which have an
obligation to transpose them, without any change of contents, into their national legislation as appropriate. New Approach directives are total harmonisation directives. That means the provisions of these directives supersede all
corresponding national provisions.
New Approach directives apply to products which are to be placed on the
Community market for the first time. Consequently, the directives apply to
new products manufactured in the Member States, and to new as well
as to second-hand products, imported from third countries. Products
that have been subject to important changes may be considered as new products too that have to comply with the provisions of the applicable directives.
But this depends on the kind of changes and has to be assessed on a case-bycase basis. Products, which only have been repaired, are not subject to conformity assessment according to the New Approach directives.
3.1 Simultaneous Application of Different Directives
What to do if more than one directive is relevant for the product you
want to export to the European Economic Area
It often happens that potential hazards of a product are covered by the essential requirements of different directives which complement each other. It is the
8
responsibility of the manufacturer to verify whether or not the product is
within the scope of one or more directives. It is extremely important to judge
during the risk assessment, which directives might be of relevance for the
product in question and consequently to apply all relevant requirements of
these directives. The placing on the market and putting into service of products can only take place when the conformity assessment has been carried out
in accordance with all applicable directives and the product complies with the
relevant provisions of all applicable directives.
3.2 New Approach Directives and the Directive on Product
Liability
You will be held liable if your products are defective and cause damage
The objective of New Approach directives is to protect the public interest with
respect of health and safety of persons, environmental protection and others.
Therefore the New Approach directives intend to prevent the placing on the
market and putting into service of non-compliant products. The directive on
product liability5 covers any defective product manufactured in or imported
into the Community, which causes damage to individuals or private property.
Therefore it is also applicable to products covered by New Approach directives.
The Directive on product liability establishes a strict liability regime on manufacturers and importers in the Community. Therefore it is in the interest of the
manufacturer, the importer and the distributor to supply safe products in order
to avoid the costs that liability places on them for defective products causing
damages to individuals or property.
4
Provisions of New Approach Directives
The New Approach directives in greater detail
4.1
Placing on the Market and Putting into Service
What is the difference between “placing on the market” and “putting
into service”?
“Placing on the market” means to make a product available for the first
time on the Community market. This usually takes place when a product
leaves the premises of the manufacturer established inside the EU or if a
product, manufactured outside the EU, is imported into the Community with
the intention to being distributed or used on the Community market. It is important to know that the concept of placing on the market refers to each in-
5
Council Directive 85/374/EEC of 25/07/1985 on the approximation of the laws, regulations and
administrative provisions of the Member States concerning liability for defective products, Official Journal L
210 , 07/08/1985
9
dividual product, manufactured as an individual unit or in series, and not to
a type of product.
“Putting into service” takes place at the moment if the product is used for
the first time in the Community by the end user. Usually a product must comply with the applicable New Approach directives when it is placed on the
Community market for the first time. But there are specific cases, where a
product can only be put into service after specific additional equipment has
been installed. In such cases the completed equipment must be conform to
the requirements of the relevant directives when it is put into service.
A product may be put into service without prior placing it on the market e.g. if
the product was manufactured for the own use. In such a case the person
who puts the product into service must assume the responsibilities of the
manufacturer. Accordingly, he must ensure that the product complies with the
relevant directives, and that appropriate conformity assessment has been carried out.
4.2 Responsibilities of Persons Involved in the Process of
Production and Distribution of Products
Many different persons with many different responsibilities
4.2.1 Manufacturer
In the context of New Approach directives, the manufacturer is any natural or
legal person who is responsible for designing and manufacturing a product
with a view to placing it on the Community market under his own name.
Any natural or legal person who assembles, packs, processes, or labels
ready-made products with a view to their being placed on the Community
market under his own name bears responsibilities of the manufacturer and is
considered as the “manufacturer”.
Any person, who changes the intended use of a product or substantially
modifies the product in such a way that other essential requirements become
applicable, is responsible for assuring the conformity of the modified product
with the relevant essential requirements of the applicable directives and is
considered as the “manufacturer” if the modified product is placed on the
market ore put into service.
The manufacturer in the sense described above, has the responsibility for the
conformity of the product to the applicable directives. In particular he has the
responsibilities laid down in the relevant directives, such as the responsibility for


designing and manufacturing the product in accordance with the
relevant essential requirements,
carrying out the conformity procedures as required by the directives,
10



affixing the CE marking to the product,
establishing a technical documentation and
drawing up the EC declaration of conformity and/or other declarations.
Depending on the directive and the conformity assessment procedure chosen,
the manufacturer may be required to submit the product to a notified body
for product testing and certification, or to have the quality system certified by
a notified body.
If the manufacturer uses finished products, ready-made parts or components,
or subcontracts these tasks, he must always retain the overall control and
have the necessary competence to take the responsibility for the product.
4.2.2
Authorised Representative
Regardless whether the manufacturer is established inside or outside the
European Union, he may appoint an authorised representative in the
Union to act on his behalf. The authorised representative may carry out certain tasks required in the applicable directives. However, there is no obligation
for a manufacturer to have an authorised representative in the Union, even if
he is established outside the European Union.
In order to be able to act on behalf of the manufacturer, the authorised representative must be established inside the European Union. Commercial
representatives of the manufacturer are usually not to be considered as
authorised representative in the meaning of New Approach directives.
The manufacturer may delegate to the authorised representative neither the
measures necessary to ensure that the manufacturing process assures compliance of the products nor the setting up of a technical documentation, unless
otherwise provided for. Further, an authorised representative cannot modify
the product on his own initiative.
But the authorised representative can, at the same time be a subcontractor
who may take part in the design and manufacture of the product, if the manufacturer retains the overall control for the product and its compliance with the
applicable directives. The authorised representative can also at the same time
act as an importer or a person responsible for placing the product on the market if his responsibilities are extended accordingly.
It is important to note that the manufacturer remains generally responsible for actions carried out by an authorised representative on his behalf.
4.2.3
Importer
The importer, responsible for placing a product on the market, must be able to
provide the market surveillance with a copy of the EC declaration of conformity and he must be able to make the technical documentation avail-
11
able, where the manufacturer is not established in the Community, and has
not nominated an authorised representative in the Community.
In order to fulfil his responsibilities the importer needs neither a mandate from
the manufacturer, nor a special relationship with the manufacturer like the
authorised representative. However, the importer should have a formal assurance from the manufacturer, that the documents mentioned above will be
made available if requested by the market surveillance authority.
4.2.4
Assembler and Installer
Where a product, already placed on the market, needs additional assembly
and/or installation before it can be put into service, the installer and assembler
must take all necessary measures to ensure that the ready assembled and
installed product still complies with the essential requirements at the
moment of first use within the Community. This applies to products where the
directive in question covers putting into service, and where such manipulations
may have an impact on the compliance of the product.
4.3
Essential Requirements
One of the cornerstones of New Approach directives
In the design phase of a product, the essential requirements play an utmost
important role. Essential requirements lay down the necessary elements for
protecting the public interest. Essential requirements are mandatory and
only products complying with the relevant essential requirements may be
placed on the market and put into service. Essential requirements provide for
a high level of protection. They arise from certain hazards related with the
product, refer to the performance of the product or lay down the principal protection objective. Often several directives may be applicable to a given product
at the same time if essential requirements of different directives need to be
applied simultaneously in order to cover all relevant protection aspects.
In order to establish, which essential requirements are relevant for a given
product, the manufacturer needs to carry out a risk assessment to determine the essential requirements applicable to the product. This analysis must
be documented and included in the technical documentation.
Essential requirements define the results to be attained, or the hazards to be
dealt with, but do not predict the technical solutions for reaching the result. This allows the manufacturers to choose the way how to meet the requirements, opens a great flexibility and allows the product design to be
adapted to technological progress.
Usually the essential requirements are set out in Annexes to the directives. Although no detailed manufacturing specifications are given, the wording is intended to be precise enough to create legally binding obligations that can be
enforced. They are also formulated as to enable the assessment of conformity
12
with those requirements, even in the absence of harmonized standards or in
case the manufacturer chooses not to apply harmonised standards.
4.4
Harmonised Standards
Not compulsory but of great importance and help
In the concept of the New Approach directives harmonised European standards play a central role. On the one hand they offer solutions, by what means
essential requirements of directives can be fulfilled. On the other hand they
give orientation, what safety level is generally accepted and forms the “state
of the technique”, if a manufacturer does not apply a harmonised standard. In
the concept of New Approach the use of harmonised standards is voluntary.
But if harmonised standards are applied, the manufacturer profits from the
“assumption of conformity” with those essential requirements, which are
covered by the standard.
Harmonised European standards are prepared by the European standards
organisations (CEN, CENELEC and ETSI) on the basis of a mandate issued by
the European Commission, in accordance with General Guidelines agreed between the Commission and the European standards organisations.
According to the internal rules of the European standards organisations, European standards must be made available from the members of the European
standards organisations as national standards in an identical way and all conflicting national standards must be withdrawn in a given period. By this
internal rule it is assured that identical standards are available in all “member
states” of the European standards organisations, which include all member
states of the European Economic Area. In order to be able to adapt standards
to the technical progress, each standard has to be reviewed every 5
years at the latest.
The titles and other bibliographic data of harmonised European standards
relevant for specific directives are published by the European Commission in
the Official Journal of the European Union. There the manufacturer will
find a list with relevant standards, which is periodically updated. This list can
be visited in the internet via the following link:
http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonisedstandards-legislation/list-references/index_en.htm
4.5
Presumption of Conformity
How to shift the burden of proof from yourself to the authorities
If the manufacturer applies a harmonised European standard the reference of
which has been published in the Official Journal, he profits from the presumption of conformity with the essential requirements of a directive, covered by the standard. Consequently in case of any doubts that his product
might not be in compliance with the essential health and safety requirements
13
of the directive, it is up to the authorities to proof that there are any deviations. The application of harmonised standards that give a presumption of conformity remains voluntary. However, if the manufacturer chooses not to follow
a harmonised standard, and uses other means of his own choice, he has the
obligation to give proof of the conformity of his product with the relevant essential requirements. The same applies if the manufacturer uses only a part of
a harmonised standard. In this case the presumption of conformity exists only
to the extent the standard has been used and covers the essential requirements of the directive.
It must be emphasised, that a harmonised standard does not necessarily
cover all essential requirements. In that case it is the obligation of the
manufacturer to use other relevant technical specifications in order to meet all
the relevant essential requirements of the directive. Nowadays the European
standards organisations are requested to publish with the harmonised standard an “Annex ZA” from which the user of the standard can recognise which
essential requirements of a directive are of relevance for the product described
in the standard and which of those requirements are covered by the standard.
But the manufacturer must know that there might be the possibility that a solution given in a standard and listed in the Annex ZA had been considered by
the Commission or by a Member State to be inadequate. In such cases a formal objection can be formulated against the standard or parts of the standard. As a result of a formal objection it is possible that the whole standard
has been removed from the list of harmonised European Standards, published
in the Official Journal. Another possibility is that there is only published a note,
that a certain part of the standard is not in conformity with a certain requirement of the directive and therefore does not give a presumption of conformity.
But despite the removal of the standard from the list in the Official Journal and
despite a comment in the Official Journal that certain parts of the standard are
not in conformity with the requirements of the directive, the harmonised Standard is still valid and still in existence. The user of the standard does not recognise in the standard or in the Annex ZA of the standard, if for certain aspects the assumption of conformity has been withdrawn. This means that if
the manufacturer would produce according to this standard, he certainly would
not fulfil the requirements of the Directive for the aspect in question.
The only possibility for the manufacturer, to minimize this risk is, to regularly visit on the Homepage of the EU the site,
http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonisedstandards-legislation/list-references/index_en.htm
where the list of harmonised standards is published and check if for the standards he wants to apply no restrictions are published.
14
4.6
The Conformity Assessment Procedures
Many possible procedures the directives make use of
According to the “Global Approach” conformity assessment is subdivided into
eight main modules and several “sub modules”, which comprise procedures applicable to the different products. The modules relate either to the design phase of products or their production phase or to both. Dependent on the
risk associated with the product in question, the assessment can be based on
the intervention of the manufacturer or of an independent third party, the so
called “notified body”. The basic modules and their possible variants can be
combined with each other in a variety of ways in order to establish adequate
conformity assessment procedures. Each New Approach directive describes the
range and contents of possible conformity assessment procedures, which are
considered to give the necessary level of protection. The directives also set out
the criteria governing the conditions under which the manufacturer can make
a choice, if more than one option is provided for.
Some modules are based on quality assurance techniques. This can help
the manufacturer to meet simultaneously the obligations based on directives
and client needs. A quality system implemented on the basis of the EN ISO
9000 series standards gives a presumption of conformity with the respective
modules in the directives, with regard to those provisions that these standards
cover, and provided that the quality system enables the manufacturer to demonstrate that the products fulfil the essential requirements of the directive in
question. It might be important for the manufacturer to know that very few
directives refer explicitly to the quality system standards. However, a
general reference can be found in DECISION No 768/2008/EC, Annex
II, Module D6 (see the following internet link)
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0082:0128:EN:PDF
.
4.7
Technical Documentation
A lot of paper work, but there is no way around it
According to the New Approach directives the manufacturer is obliged to draw
up a technical documentation containing all relevant information which is
needed to demonstrate the conformity of the product to the applicable requirements. The documentation should cover the design, manufacture and operation of the product. The documentation must be in a language understood
by the notified body involved, in order to enable him to carry out the conformity assessment procedures in a proper way.
6
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common
framework for the marketing of products, and repealing Council Decision 93/465/EEC
15
4.8
The EC Declaration of Conformity
A legal document with your signature
As a part of the conformity assessment procedure, the manufacturer or his
authorised representative established within the Community must draw up
an EC declaration of conformity when the product is placed on the market.
The EC declaration of conformity should contain all relevant directives according to which it is issued. It must be possible to identify the manufacturer, the
authorised representative if he was nominated and the notified body involved
if applicable. The declaration must allow to identify the product, and give
where appropriate a reference to harmonised standards or other normative
documents used. But generally the contents of the EC declaration of conformity are laid down, directive by directive, in accordance with the products
concerned.
Depending on the procedure, the EC declaration of conformity must either ensure that the product satisfies the essential requirements of the applicable directives, or that the product is in conformity with the type for which a typeexamination certificate has been issued and satisfies the essential requirements of the applicable directives. The declaration of conformity must be
signed by the manufacturer or his authorised representative.
The EC declaration of conformity must be drawn up in one of the official languages of the Community. If the Community directives contain no further provisions concerning the language of the declaration, the requirements of the
Member States to use a specific language must be assessed on a case by case
basis. However, for products, which are required to be accompanied by the
declaration of conformity, it has to be in the official language(s) of the country
of use.
The EC declaration of conformity must be kept for at least ten years from
the last date of manufacture of the product, unless the directive expressly
provides for any other duration.
4.9
The Notified Bodies
An independent third party must be involved in some of the conformity assessment procedures
Notified bodies carry out different tasks, such as EC-type testing or assessment of quality management systems, dependent on the assessment procedures referred to in the applicable New Approach directives. Usually the New
Approach directives require a set of different conformity assessment procedures, dependent on the risk associated with a product group. Among these
procedures it might be necessary to involve an independent third party, the so
called “notified body”. In these cases, the primary task of a notified body is
16
to provide services to the manufacturers in the framework set out in the directive.
Notified bodies are nominated respectively “notified” from the Member States
of the EU to the European Commission for one or several different tasks to be
performed in the conformity assessment procedures of one or several specific
directives. Notified bodies are free to offer their conformity assessment services, within their scope of notification, either inside or outside the Community. They may carry out these activities also on the territory of other Member
States or of third countries.
For the manufacturer it is important to know that he is free to choose any
notified body that has been designated to carry out the conformity assessment procedure in question, independent of the country in which the notified
body is established. To find out, which notified bodies are established in which
country and for which tasks they were notified, you should visit “Nando“, the
New Approach Notified and Designated Organisations Information
System on the server of the European Commission, DG Enterprise and Industry, which can be accessed via the following internet link:
http://ec.europa.eu/enterprise/newapproach/nando/ .
4.10
CE Marking
What it means and what it doesn’t
Most products, covered by New Approach or Global Approach directives must
bear the CE marking, when placed on the market in the EU or in the EEA. The
CE marking must be affixed by the manufacturer or the person equivalent to
the manufacturer or by his authorised representative established within the
EU. When affixed to products, the CE marking is comparable to a declaration by the responsible that the product conforms to all applicable requirements, and that it has been subject to the appropriate conformity assessment
procedures required by the applicable directive(s). Where products are covered by several directives, and if all these directives provide for the affixing of
the CE marking, the CE marking indicates that the product is presumed to
conform to the requirements of all these directives.
Since all products covered by New Approach directives bear the CE marking,
this marking is not intended to serve commercial purposes. It does not indicate that the product was manufactured inside the EU or that it fulfils certain
quality requirements or that necessarily an independent body was involved in
the conformity assessment procedures. The CE marking just symbolises conformity to essential public interests covered by the directives in question.
Therefore, it is to be considered as essential information to Member States’
authorities as well as to other relevant parties (for example distributors, consumers and other users). Member States are not allowed to restrict the placing
on the market and putting into service of CE marked products, unless there is
evidence that a product is not in compliance with the requirements of the directive(s).
17
The CE marking must be affixed to all new products, whether manufactured in
the Member States or in third countries, to used and second-hand products
imported from third countries, and to products that are subject to directives as
new products, but which have been considerably modified.
The CE marking must take the form below. If it is reduced or enlarged the
proportions must be respected. The CE marking must be affixed visibly, legibly
and indelibly to the product or to its data plate. Where this is not possible it
must be affixed to the packaging, if any, and to the accompanying documents,
where the directive concerned provides for such documents. In cases where a
notified body is involved in the conformity assessment phase, or in the production control phase, the applicable directives usually require that the identification number must follow the CE marking.
The affixing of legal marking (such as a protected trademark of a manufacturer), or of acceptable certification and other marks additional to the CE
marking, is allowed to the extent that such markings or marks do not create
confusion with the CE marking, and that they do not reduce the legibility and
visibility of the CE marking.
4.11
Market Surveillance
Trust is good, control is better
With the New Approach and the Global Approach a high degree of freedom but
at the same time a high degree of responsibility was assigned to the manufacturer or his authorised representative placing products on the European market. Whereas pre market control was reduced to a minimum, market surveillance became an essential tool for the enforcement of New Approach directives. Since citizens are entitled to an equivalent level of protection throughout
the single market, regardless of the origin of the product, it is the task of market surveillance to ensure that the provisions of applicable directives are complied with across the European Union. Subsequently, when necessary, market
surveillance shall take action to establish conformity. Apart from these fundamental tasks, market surveillance helps to eliminate unfair competition.
Surveillance authorities receive information on the product from two important sources: The EC declaration of conformity and the technical
documentation. These must be made available by the manufacturer, the
authorised representative established within the Community, or under certain
18
circumstances by the importer or person responsible for placing on the market. Further, the surveillance authority may request the notified body to provide information on the conduct of conformity assessment for the product in
question.
A failure to present the declaration of conformity or the technical documentation when requested by a national surveillance authority may constitute sufficient grounds for doubting the presumption of conformity with the requirements of the directive. Although it must be possible to make the technical
documentation available, it need not be kept inside the Community,
unless otherwise provided for in the applicable directives. Further, the technical documentation can be kept in any format (for example as a hard copy or
CD-ROM), which allows it to be made available within a period of time commensurate with its importance and the risk in question.
If a product is not in compliance with the requirements of a directive, corrective actions must be taken by the market surveillance authorities. The corrective action depends on the level of noncompliance, which has to be established on a case by case basis, and it has to be in accordance with the principle of proportionality:
 first, the manufacturer, or the authorised representative, should be
obliged to make the product comply with the provisions and to remedy
the infringement;
 ultimately, where other measures have failed or they are not considered
as sufficient, all appropriate measures shall be taken to restrict or prohibit the placing on the market and putting into service of the product in
question, and to ensure that it is withdrawn from the market.
Non-conformity to essential requirements must usually be considered as a
substantial non-compliance, because this may for instance, present a potential
or actual risk to the health and safety of citizens.
The decision to restrict the free movement of a CE marked product in case of
substantial non-compliance usually invokes the safeguard clause procedure. This procedure is aimed to enable the Commission to keep an overview
of such measures and to consider whether or not they are justified. In addition, the exchange of information between national surveillance authorities on
corrective actions taken, whether or not based on substantial noncompliance,
should take place, where this is considered appropriate and necessary, and
where the need for confidentiality as well as transparency can be respected.
In order to improve the information exchange between the authorities of the
Member States, a “Rapid Information Exchange” (RAPEX) system has
been set up by the Directive on general product safety to handle emergency
situations caused by consumer products that present a serious and immediate
danger. The use of this system recently has been extended to other product
groups covered by other directives.
Another important tool for market surveillance is the “Administrative Cooperation” (ADCO). Member States and European Commission are obliged to
cooperate in ADCO and to provide mutual assistance to ensure proper and uni19
form application of New Approach directives. Administrative cooperation is organised in the standing committees established under the directives, and in
the horizontal group of Senior Officials for Standardisation and Conformity Assessment Policy.
The manufacturer must be aware, that with ADCO and RAPEX instruments
are available, that allow market surveillance authorities to quickly exchange
information across Europe in case that relevant non compliances of a product
were detected. In such a case the product could be removed at the same time
from the whole European market, which would mean a heavy burden for the
manufacturer of the product in question.
20
III
European Directives Regulating Pressure Equipment
In order to harmonise national laws of the Member States of the EU regarding
the design, manufacture, testing and conformity assessment of pressure
equipment and assemblies of pressure equipment, five Directives came into
force in the EU respectively in the European Economic Area (EEA):
1. The Directive on Aerosol Dispensers (75/324/EEC).
2. The Pressure Equipment Directive (97/23/EC).
3. The Directive on Transportable Pressure Equipment (99/36/EC).
4. The Directive on Simple Pressure Vessels (2009/105/EC).
5. The Directive on Appliances Burning Gaseous Fuels
(2009/142/EC).
These directives form a legislative framework on European level for equipment
subject to a pressure hazard and help to ensure the free placing on the market
and putting into service of the equipment within the European Union and the
European Economic Area. These directives provide for a flexible regulatory environment that does not impose any detailed technical solution but allows the
industry to develop and to apply new techniques.
In the following a very brief description of these five directives is given, focussing on the scope of the directives in order to help the manufacturer to decide,
which directives are of relevance for his product.
1
Directive on Aerosol Dispensers
This Directive covers aerosol dispensers. Aerosol dispensers are defined as
"Non-reusable containers made of metal, glass or plastic and containing a gas
compressed, liquefied or dissolved under pressure, with or without a liquid,
paste or powder, and fitted with a release device allowing the contents to be
ejected as solid or liquid particles in suspension in a gas, as a foam, paste or
powder or in a liquid state".
For this kind of products the following legislation is in force:
Aerosol Dispensers Directive 75/324/EEC (ADD)7 of 20 May 1975, which
can be accessed via the following internet link:
7
Council Directive of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (75/324/EEC) (OJ L 147, 9.6.1975, p. 40)
21
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31975L0324:en:HTML
This directive was amended by:
Commission Directive 94/1/EC of 6 January 1994, adapting some technicalities, which can be accessed via the following internet link:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31994L0001:en:NOT .
Commission Directive 2008/47/EC of 8 April 2008, adapting to technical
progress, which can be accessed via the following internet link:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008L0047:en:NOT
2
Pressure Equipment Directive
The Pressure Equipment Directive (97/23/EC)8 was adopted by the European Parliament and the European Council in May 1997 and became obligatory
throughout the EU from 29 May 2002 onward.
The Directive has a wide scope and covers most items relevant in pressurised systems, such as

vessels,

pressurised storage containers,

heat exchangers,

steam generators,

boilers,

industrial piping,

safety devices,

pressure accessories.
Such pressure equipment is used in the process industries such as oil & gas,
chemical, pharmaceutical, plastics and rubber and the food and beverage industry. It is also used in high temperature process industry such as glass, paper and board industry, as well as in energy production and in the supply of
utilities, heating, air conditioning and gas storage and transportation. In order
to verify precisely, which products are covered by this directive it is recommended to consult the directive for further details. This directive distinguishes
between pressure equipment and assemblies above or below specified pressure and/or volume thresholds:
8
Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of
the laws of the Member States concerning pressure equipment (OJ L 181, 9.7.1997, p. 1)
22
Pressure equipment and assemblies above specified pressure and/or volume
thresholds must

be safe;

meet essential safety requirements covering design, manufacture
and testing;

satisfy appropriate conformity assessment procedures; and

carry the CE marking and other information.
Pressure equipment and assemblies below the specified pressure / volume
thresholds must

be safe;

be designed and manufactured according to sound engineering practice; and

bear specified markings (but not the CE marking).
For further details see the wording of the directive which can be accessed
via the following internet link:
http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1997L0023:20031120:en:PDF
In order to facilitate the use of the Directive, the Commission together with
Member States’ experts has elaborated Guidelines, which can be accessed via
the following internet link:
http://ec.europa.eu/enterprise/sectors/pressure-andgas/documents/ped/guidelines/index_en.htm
3
Directive on Transportable Pressure Equipment
For the improvement of safety with regard to transportable pressure equipment approved for the inland transport of dangerous goods by road and by
rail, the European Union has issued in 1999 the Transportable Pressure
Equipment Directive TPED (1999/36/EC)9. The Directive aims simultaneously to ensure the free movement of such equipment within the Community,
including the placing on the market and repeated putting into service and repeated use aspects. This directive was amended several times.
9
Council Directive 1999/36/EC of 29 April 1999 on transportable pressure equipment, O J L 138 ,
01/06/1999 P. 0020 - 0056
23
The Directive and the amendments can be accessed via the following internet
links:

Council Directive 1999/36/EC of 29 April 1999 on transportable
pressure equipment, O J L 138 , 01/06/1999 P. 0020 - 0056

Commission Directive 2002/50/EC of 6 June 2002 adapting to technical
progress Council Directive 1999/36/EC on transportable pressure
equipment, OJ L 149, 7.6.2002, page 28

Commission Decision 2003/525/EC of 18 July 2003 deferring the date of
implementation of Council Directive 1999/36/EC for certain transportable pressure equipment (notified under document number C(2003)
2591) OJ L 183, 22.7.2003, page 45
In order to facilitate the use of the Directive, the Commission together with
Member States’ experts has elaborated TPED Guidelines, which can be accessed via the following internet link:
http://ec.europa.eu/transport/tpe/guide_cat_en.html
4
Directive on Simple Pressure Vessels
The Directive on Simple Pressure Vessels (2009/105/EC)10 came into
force in December 2009. It replaces Directive 87/404/EEC of 25 June 1987.
“For the purposes of this Directive, "simple pressure vessel" means any welded
vessel subjected to an internal gauge pressure greater than 0,5 bar which is intended to contain air or nitrogen and which is not intended to be fired”.
The Directive can be accessed via the following internet link:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:264:0012:0029:en:PDF
Although this directive will be dealt with in greater detail in the chapters C and
D, the guidelines for the application of the Simple Pressure Vessels Directive are mentioned in this introductory chapter. These guidelines are developed in order to ensure a coherent application of the Simple Pressure Vessels Directive. The Guidelines are established and agreed in the framework of
the Commission's working group on Simple Pressure Vessels, based on the
experience made with the application of the directive by the working group
and the industry. These guidelines can be accessed via the following internet
link:
http://ec.europa.eu/enterprise/sectors/pressure-and-gas/files/spv_allguidelines06_2000_en.pdf
10
Directive 2009/105/EC of the European Parliament and of the Council of 16 September 2009, relating to
simple pressure vessels, OJ L 264, 8.10.2009, P. 0012 - 0029
24
5
Directive on Appliances Burning Gaseous Fuels
This Directive on Appliances burning gaseous fuels (2009/142/EC)11
(Gas Appliances Directive, GAD) came into force in January 2010. It is the
codified version, replacing Directive 90/396/EEC and its amendments. This
directive is restricted to appliances burning gaseous fuels used for cooking,
heating, hot water production, refrigeration, lighting and washing, i.e.
common consumer and commercial products. Appliances specifically designed
for use in industrial processes carried out on industrial premises are excluded
from this directive. With the GAD a system was introduced, constituting a legal
framework for gas appliances in the Community Member States. It aims to
provide access to the Community market for appliances and fittings so far the
gas safety of these products is concerned.
The directive can be accessed via the following internet link:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:330:0010:0027:en:PDF
Further information in support of the application of the directive can be found
in “Guidance Sheets”, which can be accessed via the following internet link:
http://ec.europa.eu/enterprise/sectors/pressure-andgas/documents/gad/guidances/index_en.htm
Although the GAD covers the technical harmonisation of gas appliances and
fittings, there are still differences in the types of gas and corresponding
supply pressures in the Member States that have an impact on the design
of appliances and fittings.
According to Article 2(2) of the GAD the Member States are obliged to
communicate to the other Member States and to the Commission all changes
to the types of gas and corresponding supply pressures used on their territory.
This information is published by the Commission in the Official Journal of the
European Union. Via the following internet link these communications can be
accessed:
http://ec.europa.eu/enterprise/sectors/pressure-and-gas/documents/gad/types/index_en.htm
11
Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009, relating to
appliances burning gaseous fuels, OJ L 330, 16.12.2009 P. 0010 - 0027
25
IV
The Simple Pressure Vessels Directive (2009/105/EC)
In this part it will be explained, what a manufacturer should know if he wants
to export Simple Pressure Vessels (SPV) into the European Union or the European Economic Area. The single steps of the design phase, the conformity assessment phase and the product marketing will be explained on the basis of
the Simple Pressure Vessels Directive (2009/105/EC) and the relevant parts of
the actual legislative framework. However it must be emphasised that before
going into further details, the manufacturer should, on the basis of the information given in chapter III check very thoroughly whether his product is covered by the Simple Pressure Vessels Directive or by any other Directive.
1
The Development of Today’s Simple Pressure Vessels Directive
The Council Directive 87/404/EEC of 25 June 1987 on the harmonisation of the
laws of the Member States relating to simple pressure vessels came into force
on July 1, 1990 and has been mandatory since July 1, 1992. The main aim of
this Directive was to ensure the free movement of simple pressure vessels
within the Community market by completely harmonizing the safety requirements to which they must conform. This directive has been amended twice:
1. By Council Directive 90/488/EEC of 17 September 1990.
2. By Council Directive 93/68/EEC of 22 July 1993.
On 28th October 2009 Directive 2009/105/EC of 16 September 2009 on
the harmonisation of the laws of the Member States relating to simple
pressure vessels12 came into force. This directive replaces Directive
87/404/EEC following a codification including the amendments to the original
directive. This Directive can be accessed via the following internet link:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:264:0012:0029:en:PDF
The Simple Pressure Vessels Directive 2009/105/EC sets the essential safety
and health requirements for in series produced simple pressure vessels. The
safety requirements formulated in the Directive are applicable to the use of
materials, design, manufacturing method and placing the pressure vessels on
the market. In this Directive, "simple pressure vessel" means any welded
vessel produced in series and subjected to a working pressure PS in the
range 0,5 bar < PS ≤ 30 bar. The product of that pressure and the capacity
of the vessel (PS x V) shall not exceeding 10 000 bar∙l. The vessel must
be intended to contain air or nitrogen and must not be intended to be fired.
12
Directive 2009/105/EC of 16 September 2009 on the harmonisation of the laws of the Member States
relating to simple pressure vessels (OJ-L 264-08/10/2009)
26
2
The overall structure of the Simple Pressure Vessels
Directive
Annex 1 of this brochure contains a complete copy of Directive 2009/105/EC.
It is highly recommended to have a look into this document before starting to
produce Simple Pressure Vessels (SPV) for the European market. But not all
articles are of relevance for the manufacturer. Some of the articles are addressing to the market surveillance authorities, to the member states, to the
European Commission or to notified bodies. For a better orientation the overall
structure of the Directive is explained in the following very briefly, emphasising those parts which are of relevance for the manufacturer or his authorised
representative. Besides a look into the original Directive in Annex 1 of this
brochure, it is highly recommended to also consult the “Guide on Simple Pressure vessels” which can be accessed via the following internet-link:
http://ec.europa.eu/enterprise/sectors/pressure-and-gas/files/spv_allguidelines06_2000_en.pdf
This Guide reflects the experience gathered in more than 20 years by manufacturers, notified bodies, market surveillance and other actors when applying
the different versions of the SPV-Directive.
2.1
The Articles of the SPV Directive
The SPV-Directive is subdivided into four chapters:
Chapter I: Scope, definitions, placing on the market and free movement.
Scope, definitions: Article 1,
Placing on the market and free movement: Articles 2, 3, 4, 5, 6, 7
Chapter II: Certification
Section 1: Certification procedures: Articles 8 + 9
Section 2: EC type-examination: Article 10
Section 3: EC verification: Article 11
Section 4: EC declaration of conformity: Articles 12, 13, 14
Chapter III: ‘CE’ marking and inscriptions
Articles 15 + 16
Chapter IV: Final provisions
Articles 17, 18, 19, 20, 21
In the following, a brief description of the single articles is given:
27
Article 1 is of great importance for the manufacturer since it defines which
pressure vessels are covered by this directive and which products are excluded
from its scope. It also contains some details on the basic design of pressure
vessels:
This Directive applies to welded vessels,
 manufactured in series,
 with an internal gauge pressure greater than 0,5 bar
 intended to contain air or nitrogen
 not intended to be fired
 with a maximum working pressure not exceeding 30 bar
 with a product of that pressure and the capacity of the vessel (PS x
V) not exceeding 10 000 bar∙l.
In addition some restrictions with respect to the construction and to the
temperatures applicable are given
Article 2 is addressing to the Member States, but it implicitly contains the
fundamental safety requirement:
“…the vessels may be placed on the market and put into service only if
they do not compromise the safety of persons, domestic animals or
property when properly installed and maintained and used for the purposes for which they are intended”
In this respect this article is of relevance for the manufacturer too.
Article 3 is very important for the manufacturer. In Article 3 pressure vessels
are subdivided into two groups:
1. The product of working pressure PS and Volume V (PS x V) exceeds
50 bar∙l. or
2. This product is smaller or equals 50 bar∙l.
The safety requirements, laid down in Annex I, and the conformity assessment and verification procedures described in the following Articles are only
applicable for pressure vessels of group 1.
For pressure vessels of group 2 it is only required that they are manufactured
in accordance with the ‘sound engineering practice’ of one of the Member
States and that they bear markings as laid down in point 1 of Annex II, with
the exception of the ‘CE’ marking.
Article 4 is addressing to the Member States and has no direct relevance for
the manufacturer.
Article 5 is addressing to the Member States. But it introduces some elements which are of very high relevance for the manufacturer too:
28
1. The “CE marking”
2. The “Harmonised European Standards”
3. The principle of “presumption of conformity”
4. The “EC type-examination” and “EC type-examination certificate”
5. The applicability of different Directives, where vessels are subject to
other Directives covering other aspects.
Article 6 is addressing to the Member States and to the Commission and has
no direct relevance for the manufacturer.
Article 7 is addressing to the Member States and to the Commission, but it
might be of some relevance for the manufacturer too, since it regulates how
none conform products, detected on the Community market, must be handled by the market surveillance authorities.
Article 8 is of great relevance for manufacturers of simple pressure vessels. It
provides for the different conformity assessment procedures applicable
for different types of pressure vessels. These depend on the question if harmonised standards were applied completely, partially or not at all on one
hand, and on the magnitude of the product PS x V on the other. This Article
requires that pressure vessels are subject to the “EC verification” where the
product PS x V is exceeding 3000 bar∙l. If the product PS x V is not exceeding 3000 bar∙l, the manufacturer can choose between two procedures, the “EC declaration of conformity” and the “EC verification”.
Article 9 is addressing to the Member States and to the Commission and has
no direct relevance for the manufacturer.
Article 10 is of importance for the manufacturer and for the “inspection body”
(notified body). It provides for details of the EC type-examination. It describes the requirements for the application by the manufacturer as well as the
details of the EC type-examination to be performed by the inspection body. It
also provides for the handling of the EC type-examination certificate, which
is to be issued by the inspection body after a positive result in the EC typeexamination.
Article 11, describing the “EC verification”, is addressing to the manufacturer and to the inspection body and is of high relevance for both. The EC verification is the procedure by which an approved inspection body verifies and
confirms that the pressure vessels produced in series conforms to the requirements of the SPV-Directive and to the type described in the EC typeexamination certificate or the design and manufacturing schedule.
29
Article 12, introducing the “EC declaration of conformity”, is of relevance
for SPV in the range 50 bar∙l. < PS x V ≤ 3.000 bar∙l, if not applying “EC verification”. It also introduces the “EC surveillance”, which is obligatory for
these pressure vessels with PS x V exceeding 200 bar∙l.
Article 13 is of relevance for those manufacturers who make use of or who
are bound to apply the EC surveillance procedure. It introduces requirements
for the “document describing the manufacturing processes and all of
the predetermined systematic measures taken to ensure conformity of
the pressure vessels to the standards referred to in Article 5(1) or the
approved prototype”. It also introduces the requirements for manufacturers
of vessels with PS x V exceeding 200 bar∙l, which are subject to the EC surveillance.
Article 14 is addressing to the inspection body involved in the EC surveillance.
Article 15 is addressing to the Member States and describes how Member
States must treat cases where the ‘CE’ marking has been affixed unduly.
But this Article is of some relevance for the manufacturer too, since if the
manufacturer does not bring the product in conformity with the provisions
concerning the ‘CE’ marking, this might lead to a withdrawal of the product
from the market by the authorities.
Article 16 is addressing to the manufacturer and gives details on how to affix the ‘CE’ marking and therefore is of high relevance for the manufacturer.
Articles 17, 18, 19, 20 and 21, containing the “final provisions”, are addressing to the Member States and are of less relevance for the manufacturer.
30
2.2
The Annexes of the SPV Directive
The SPV Directive has 5 Annexes. In this chapter all Annexes are briefly
described. Those Annexes which are of relevance for the manufacturer will be
dealt with in greater detail in the following Chapter of this brochure.
Annex I
“Essential Safety Requirements”
This Annex is of high relevance for manufacturers producing Simple Pressure
Vessels the product PS x V of which exceeds 50 bar∙l.
This Annex contains in four chapters all applicable requirements with respect
to
1. Materials
2. Vessel Design
3. Manufacturing Process and
4. Putting into Service of the Vessels
Annex II
“‘CE’ Marking, Inscriptions, Instructions, Design and Manufacture Schedules, Definitions and Symbols”
This Annex is again of high relevance for manufacturers producing Simple
Pressure Vessels, the product PS x V of which exceeds 50 bar∙l. But this Annex
is also of relevance for those manufacturers who produce Simple Pressure
Vessels, the product PS x V is ≤ 50 bar∙l. The Annex covers in four chapters:
1. ‘CE’ Marking and Inscriptions
2. Instructions
3. Design and Manufacturing Schedules and
4. Definitions and Symbols
Annex III
“Minimum Criteria to be met by Member States for the Approval of Inspection Bodies”
This Annex is relevant for the accreditation and notification of bodies by the
Member States and of no relevance for the manufacturer.
31
Annex IV
“Repealed Directive with list of its successive amendments” and “List
of time limits for transposition into national law and application”
This Annex is relevant for the Member States and of little relevance for the
manufacturer.
Annex V
“Correlation Table”
In the Correlation Table of Annex V the correlation between the different Articles and Annexes of the former Directive 87/404/EEC and amendments and
the current Directive 2009/105/EC is given. This Annex is of little relevance for
the manufacturer.
32
V
How the Manufacturer Should Apply the SPVD
In the following chapters specific information will be given to the manufacturer
in order to give him support, when producing Simple Pressure Vessels (SPV)
for the EU-market or the even bigger market of the European Economic Area
(EEA). Although in some cases, when necessary, the wording of certain Articles or paragraphs of the Directive will be cited, this brochure can’t replace the
Directive. It is therefore recommended to also consult the text of the Directive for Simple Pressure Vessels attached in Annex 1 of this brochure. The
Directive can also be accessed on the homepage of the European Commission
via the following internet link, allowing the user to choose from different language versions:
http://eur-lex.europa.eu/RECH_naturel.do
On this page one has to check the box “Directive” and has to enter in
“year”: 2009 and in “number”: 105, pressing now “search” leads to the
start page from the SPV-Directive, where you have to check the box for “Languages and formats available” and press the “Go” button. Opening the
page from which one can select the format and the language suitable.
Sometimes it might be difficult to understand the proper meaning of the wording in the Directive. In these cases it is highly recommended to have a look
into the “Guide on Simple Pressure vessels” which can be accessed via the
following internet-link:
http://ec.europa.eu/enterprise/sectors/pressure-and-gas/files/spv_allguidelines06_2000_en.pdf
Since it is not always easy to follow the wording of the directive, referring to
other Articles and paragraphs and introducing certain limit values due to which
other procedures are to be applied, it might be helpful to now and then consult
the flow chart given hereafter for better orientation.
33
Flow chart for the conformity assessment procedures provided for in
Directive 2009/105/EC
Chart 1
……Chart 2
34
Chart 2
35
1
Is the Product Covered by the SPV Directive?
The first step to do as a manufacturer is to make sure that the product to
export into the European Union (EU) or into the European Economic Area
(EEA) is in the scope of the SPV Directive. For this purpose the manufacturer
has to consult
Article 1:
1. This Directive applies to simple pressure vessels manufactured in series.
2. The following vessels shall be excluded from the scope of this Directive:
(a) vessels specifically designed for nuclear use, failure of which may
cause an emission of radioactivity;
(b) vessels specifically intended for installation in or the propulsion of
ships and aircraft;
(c) fire extinguishers.
3. For the purposes of this Directive the following definitions shall apply:
(a) ‘simple pressure vessel’ or ‘vessel’ means any welded vessel subjected to an internal gauge pressure greater than 0,5 bar which is
intended to contain air or nitrogen and which is not intended to be
fired.
The parts and assemblies contributing to the strength of the vessel under
pressure shall be made either of non-alloy quality steel or of nonalloy aluminium or non-age hardening aluminium alloys.
The vessel shall be made of either:
(i) a cylindrical part of circular cross-section closed by inwardly dished
and/or flat ends which revolve around the same axis as the cylindrical part;
or
(ii) two dished ends revolving around the same axis.
The maximum working pressure of the vessel shall not exceed 30
bar and the product of that pressure and the capacity of the vessel
(PS x V) shall not exceed 10 000 bar.l.
The minimum working temperature must be no lower than – 50 °C
and the maximum working temperature must not be higher than
300 °C for steel and 100 °C for aluminium or aluminium alloy vessels;
In the “Guide on Simple Pressure vessels”, the link to which is given at
the beginning of chapter V, the following check list is mentioned, helping to
determine whether a vessel may be considered as a simple pressure vessel:
(i) Geometry of vessel simple:
(ii) Material of construction (steel /aluminium):
(iii) Contents (air/nitrogen):
36
(iv)
(v)
(vi)
(vii)
Internal pressure greater than 0.5 bar:
Internal pressure not exceeding 30 bar:
Pressure x volume product not exceeding 10 000 bar.litres
Operating temperature:
 for steel vessels: -50°C to 300°C
 for aluminium vessels: -50°C to 100°C
(viii) Manufactured in series:
(ix) Intended to be unfired:
(x) All risks covered by Directive:
If all points can be answered with yes, and if the exclusions in Article 1 are of
no relevance, the vessel may be considered as a SPV.
If the product in view may not be considered as a SPV, and if it is not
explicitly excluded from the SPV-Directive under Article 1(2) a, b, c, it is most
likely that the product is covered by the Pressure Equipment Directive
(97/23/EC). Nevertheless it is recommended to check if one of the other following Directives may cover the product in question:
1. Aerosol Dispensers Directive 75/324/EEC , which can be accessed via
the following internet link:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:01975L0324-20030605:en:NOT
2. Pressure Equipment Directive (97/23/EC), which can be accessed via
the following internet link:
http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1997L0023:20031120:en:PDF
3. Directive on Transportable Pressure Equipment, which can be
accessed via the following internet links:

Council Directive 1999/36/EC of 29 April 1999 on transportable
pressure equipment, O J L 138 , 01/06/1999 P. 0020 - 0056

Commission Directive 2002/50/EC of 6 June 2002 adapting to technical
progress Council Directive 1999/36/EC on transportable pressure
equipment, OJ L 149, 7.6.2002, page 28

Commission Decision 2003/525/EC of 18 July 2003 deferring the date of
implementation of Council Directive 1999/36/EC for certain transportable pressure equipment (notified under document number C(2003)
2591)
OJ L 183, 22.7.2003, page 45
4. Directive on Appliances Burning Gaseous Fuels (2009/142/EC) can
be accessed via the following internet link:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:330:0010:0027:en:PDF
37
2
What requirements must be fulfilled before the SPV can
be put on the market?
If the vessel to be produced is a simple pressure vessel and as such covered
by the SPV-Directive, the next step will be to decide, which procedures must
be followed.
In this respect Article 3 is of relevance:
1. Vessels in respect of which the product of PS x V exceeds 50 bar.l
must satisfy the essential safety requirements set out in Annex I.
2. Vessels in respect of which the product of PS x V is 50 bar.l or less
must be manufactured in accordance with sound engineering practice in
one of the Member States and bear markings as laid down in point 1 of Annex II, with the exception of the ‘CE’ marking referred to in Article 16.
2.1
Vessels with PS x V ≤ 50 bar∙l
For vessels described in Article 3 (2) (PS x V ≤ 50 bar∙l), the following requirements are applicable:
1. The vessels must be manufactured in accordance with the “sound engineering practice” of one of the member states. The “sound engineering
practice” is usually fixed in national standards, in documents published
by national engineering or manufacturer associations or in factory standards.
2. These vessels must be marked with markings, laid down in point 1 of
Annex II, but with the exception of the CE marking, meaning that the
markings of these SPV are limited to the following inscriptions:
(a) the maximum working pressure (PS in bar);
(b) the maximum working temperature (T
(c) the minimum working temperature (T
max
min
in °C);
in °C);
(d) the capacity of the vessel (V in l);
(e) the name or mark of the manufacturer;
(f) the type and serial or batch identification of the vessel;
(g) the last two digits of the year in which the ‘CE’ marking was affixed.
Where the data plate is used, it must be so designed that it cannot be reused and must include a vacant space to enable other information to be provided.
2.2
Vessels with PS x V > 50 bar∙l
For SPV described in Article 3(1) (PS x V exceeding 50 bar.l) the requirements, laid down in Annex I must be applied.
38
Annex I contains in four chapters the “essential safety requirements” for
1. Materials
2. Vessel Design
3. Manufacturing Process
4. Putting into service of the vessel
The four chapters are cited hereunder in paragraph 2.2.1 through 2.2.4:
2.2.1 Materials
With respect to the materials used for the SPV, Annex I contains the following requirements:
1. Materials
Materials must be selected according to the intended use of the vessels and
in accordance with points 1.1 to 1.4.
1.1. Pressurised parts
The materials referred to in Article 1 used for manufacturing the pressurised parts of the vessels must be:
(a) capable of being welded;
(b) ductile and tough, so that a rupture at minimum working temperature
does not give rise to either fragmentation or brittle-type fracture;
(c) not adversely affected by ageing.
For steel vessels, the materials must in addition meet the requirements set
out in point 1.1.1 and, for aluminium or aluminium alloy vessels, those set
out in point 1.1.2.
They must be accompanied by an inspection slip as described in Annex II,
drawn up by the producer of the materials.
1.1.1. Steel vessels
Non-alloy quality steels shall meet the following requirements:
(a) they must be non-effervescent and supplied after normalisation treatment, or in an equivalent state;
(b) the content per product of carbon must be less than 0,25 % and that of
sulphur and phosphorus must each be less than 0,05 %;
(c) they must have the following mechanical properties per product:
— the maximum tensile strength Rm,max must be less than
580 N/mm 2 ,
— the elongation after rupture must be:
— if test pieces are taken parallel to the direction of rolling:
thickness ≥ 3 mm:
A ≥ 22 %,
thickness < 3 mm:
A
80 mm
39
≥ 17 %,
— if test pieces are taken perpendicular to the direction of
rolling:
thickness ≥ 3 mm:
A ≥ 20 %,
thickness < 3 mm:
A
80 mm
≥ 15 %,
— the average failure energy KCV for three longitudinal test pieces at
minimum working temperature must not be less than 35 J/cm 2 . Not
more than one of the three figures may be less than 35 J/cm 2, with a
minimum of 25 J/cm 2.
In the case of steels used in the manufacture of vessels the minimum
working temperature of which is lower than – 10 °C and the wall thickness of which exceeds 5 mm, this property must be checked.
1.1.2. Aluminium vessels
Non-alloy aluminium must have an aluminium content of at least
99,5 % and the alloys referred to in Article 1(3)(a) must display adequate
resistance to intercrystalline corrosion at maximum working temperature.
Moreover, these materials must satisfy the following requirements:
(a) they must be supplied in an annealed state; and
(b) they must have the following mechanical characteristics per product:
— the maximum tensile strength Rm,max must be
no more than 350 N/mm 2 ,
— the elongation after rupture must be:
— A ≥ 16 % if the test piece is taken parallel to the direction of
rolling,
— A ≥ 14 % if the test piece is taken perpendicular to the direction of rolling.
1.2. Welding materials
The welding materials used to manufacture the welds on or of the simple
pressure vessel must be appropriate to and compatible with the materials
to be welded.
1.3. Accessories contributing to the strength of the vessel
These accessories (for example bolts and nuts) must be made of a material
specified in point 1.1 or of other kinds of steel, aluminium or an appropriate aluminium alloy compatible with materials used for the manufacture of
pressurised parts.
The latter materials must at minimum working temperature have an appropriate elongation after rupture and toughness.
1.4. Non-pressurised parts
All unpressurised parts of welded vessels must be of materials which are
compatible with that of the components to which they are welded.
40
With respect to the materials allowed for use, Annex I is comprehensive. But it
must be emphasised that the vessels must be accompanied by an inspection slip for the materials used in the manufacture of parts and assemblies
contributing to the strength of the pressure vessel, drawn up by the producer
of the materials.
2.2.2
Vessel Design
With respect to the design of the SPV, Annex I contains the following requirements:
2. Vessel Design
The manufacturer must, when designing the vessel, define the use to which
it will be put, and select:
(a) the minimum working temperature T
(b) the maximum working temperature T
min
;
max
;
(c) the maximum working pressure PS.
However, should a minimum working temperature exceeding – 10 °C be
selected, the qualities required of the materials must be satisfied at – 10
°C.
The manufacturer must also take account of the following provisions:
— it must be possible to inspect the inside of vessels,
— it must be possible to drain the vessels,
— the mechanical qualities must be maintained throughout the period of
use of the vessel for the intended purpose,
— the vessels must, bearing in mind their prescribed use, be adequately
protected against corrosion,
and the fact that under the conditions of use envisaged:
— the vessels must not be subjected to stresses likely to impair their
safety in use,
— internal pressure must not permanently exceed the maximum working
pressure PS. However, it may momentarily do so by up to 10 %.
Circular and longitudinal seams must be made using full penetration welds
or welds of equivalent effectiveness. Convex ends other than hemispherical
ones must have a cylindrical edge.
It must be emphasised that according to 2.1, dependent on the magnitude of
the product PS x V respectively on the working temperature the manufacturer must apply different methods, described as “calculation method” in
2.1.1 or “experimental method” in 2.1.2 for the determination of the wall
thickness:
2.1. Wall thickness
If the product of PS × V is not more than 3 000 bar.l, the manufacturer must select one of the methods described in points 2.1.1 and 2.1.2
41
for determining vessel wall thickness; if the product of
PS × V is more than 3 000 bar.l, or if the maximum working temperature exceeds 100 °C, such thickness must be determined by the
method described in point 2.1.1.
The actual wall thickness of the cylindrical section and ends shall, however,
be not less than 2 mm in the case of steel vessels and not less than 3 mm
in the case of aluminium or aluminium alloy vessels.
2.1.1. Calculation method
The minimum thickness of pressurised parts must be calculated having regard to the intensity of the stresses and to the following provisions:
(a) the calculation pressure to be taken into account must not be less than
the maximum working pressure PS selected;
(b) the permissible general membrane stress must not exceed the lower of
the values 0,6 R ET or 0,3 R m . The manufacturer must use the R ET and R m
minimum values guaranteed by the material manufacturer in order to determine the permissible stress.
However, where the cylindrical portion of the vessel has one or more longitudinal welds made using a non-automatic welding process, the thickness
calculated as referred to in the first paragraph must be multiplied by the
coefficient 1,15.
2.1.2. Experimental method
Wall thickness must be so determined as to enable the vessels to resist at
ambient temperature a pressure equal to at least five times the maximum
working pressure, with a permanent circumferential deformation factor of
no more than 1 %.
2.2.3
The Manufacturing Process
With respect to the manufacturing process, the following requirements from
Annex I must be fulfilled:
3. Manufacturing process
Vessels shall be constructed and subjected to production checks in accordance with the design and manufacturing record referred to in point 3 of
Annex II.
Annex II (3)
3. DESIGN AND MANUFACTURING SCHEDULES
The design and manufacturing schedules must contain a description of the techniques and operations employed in order to
meet the essential safety requirements set out in Annex I or the
harmonised standards referred to in Article 5(1), and in particular:
(a) a detailed manufacturing drawing of the vessel type;
42
(b) the instructions;
(c) a document describing:
— the materials selected,
— the welding processes selected,
— the checks selected,
— any pertinent details as to the vessel design.
When the procedures laid down in Articles 11 to 14 are applied,
the schedule must also include:
(a) the certificates relating to the suitable qualification of the
welding operations and of the welders or operators;
(b) the inspection slip for the materials used in the manufacture
of parts and assemblies contributing to the strength of the pressure vessel;
(c) a report on the examinations and tests performed or a description of the proposed checks.
3.1. Preparation of the component parts
Preparation of the component parts (for example forming and chamfering)
must not give rise to surface defects or cracks or changes in the mechanical characteristics likely to be detrimental to the safety of the vessels.
3.2. Welds on pressurised parts
The characteristics of welds and adjacent zones must be similar to those of
the welded materials and must be free of any surface or internal defects
detrimental to the safety of the vessels.
Welds must be performed by qualified welders or operators possessing the
appropriate level of competence, in accordance with approved welding
processes. Such approval and qualification tests must be carried out by approved inspection bodies.
The manufacturer must also, during manufacture, ensure consistent weld
quality by conducting appropriate tests using adequate procedures. These
tests must be the subject of a report.
2.2.4
Putting into Service
According to Point 4 of Annex I the following requirement must be fulfilled:
4. Putting into Service of the Vessel
Vessels must be accompanied by the instructions drawn up by the manufacturer, as referred to in point 2 of Annex II.
43
The manufacturer must draw up instructions as described in point 2 of Annex
II. These instructions must accompany the vessel when it is placed on the
market and put into service.
Point 2 of Annex II contains the following requirements for the instructions:
Annex II
2. INSTRUCTIONS
The instructions must contain the following information:
(a) the particulars given in point 1 except for the vessel’s serial
identification;
(b) the intended use of the vessel;
(c) the maintenance and installation requirements for vessel
safety.
They must be in the official language or languages of the country of destination.
2.3
Risk Assessment
The following chapter, explaining the role of risk assessment, will be more
generally referring to “pressure equipment” instead of “simple pressure
vessels”, since risk assessment has to be applied to the whole and not just to
a single element of a system. Risk assessment is the key element for finding
out, which essential safety requirements are of relevance for a system, containing pressure equipment. The outcome of risk assessment, taking into account all phases of the foreseeable lifetime of the pressure equipment, will reveal which hazards do exist and are related to what risks, and hence which essential safety requirements are of relevance.
Before going into more detail, the meaning of three expressions must be
explained:
Hazard means a potential source of harm. The presence of a hazard is
independent of whether or not any injury or damage to health is actually likely
to occur. Examples of hazards might be parts with high temperature that may
cause burns or sharp blades that might cause cuts. During hazard
identification, a hazard must be considered to be present, even if the part of
the equipment presenting the hazard is inaccessible.
Risk depends on the hazards generated by the equipment and also on the
interface between the equipment and the operators and other exposed
persons. Even if a hazard is present in connection with the equipment, there
will be no risk if no person is exposed to that hazard. One can characterise a
risk either by referring to the hazard (e.g. risk due to contact with hot
surfaces) or by referring to the possible consequences (e.g. risk of being
burnt).
44
Risk assessment means the estimation of the risk, taking into account the
severity of the possible injury or damage to health and the probability of its
occurrence (e.g. the more severe the injury or damage to health, and the
higher the probability of occurrence, the higher will be the risk).
In principle risk assessment consist of the following steps:

Identification of the uses for which the pressure equipment is intended

Identification how the pressure equipment is likely to be used and also
reasonably foreseeable could be misused

Identification of the hazards in connection with the use and operation
of the pressure equipment

Assessment of the level of injury or harm that can result from
exposure to each hazard and the probability of its occurrence

Evaluation of the risks, with a view to determining whether risk
reduction is required, in accordance with the objective of this
Directive,

Assessment of the safety measures that may be used and the
protection that they can provide

Minimisation of the risks by selecting safety measures that can be
integrated into the design.
Risks must be evaluated on a case-by-case basis, taking into account the fact
that risks may be different in the different phases of the life of the pressure
equipment, depending on the operations concerned and the state of the
pressure equipment during each phase.
A useful document explaining how to perform the risk assessment in the
context of machinery is currently the standard ISO 14121 . This standard is
made up of two documents:


ISO 14121-1 – Safety of Machinery – Risk Assessment – Part 1:
Principles
ISO/TR 14121-2 – Safety of machinery — Risk assessment — Part 2:
Practical guidance and examples of methods
This standard deals primarily with the “Preliminary Hazard Analysis” (PHA)
method, and provides guidance on using “Failure Mode and Effects Analysis”
(FMEA), “Failure to Acquire Rate” (FTA), Hazard & Operability Studies (HAZOPS) and other systems to analyze the risks.
After having carried out the risk assessment, and having revealed the relevant
hazards and the resulting risks, the manufacturer must go through the applicable parts of the Annex I and identify those essential safety requirements,
the pressure equipment must comply with. At this point it must be underlined
that the essential safety requirements are applicable only when the corresponding hazard exists for the pressure equipment in question. In the follow45
ing those requirements are called “the relevant essential safety requirements”
The pressure equipment must then be designed and constructed according to
the principles of safety integration, taking into account the results of the risk
assessment. But risk assessment is an iterative process because each risk reduction measure must be evaluated to see if it is adequate and does not generate new hazards. This implies that the risk assessment process must be carried out in parallel with the design process of the pressure equipment. During
the design phase the designer must deal with the risks that have been identified and assessed by means of the risk assessment, according to the following
approach, often referred to as the “3-step method”:
Step 1 = Inherently safe design measures
Step 2 = Technical protective measures
Step 3 = Information for users
(1. priority)
(2. priority)
(3. priority)
The three steps include an order of priority that must be applied by the designer when selecting measures to deal with a given risk in order to satisfy the
corresponding essential safety requirements. As a consequence the designer
must apply all possible inherently safe design measures before applying protective measures. Similarly, he must apply all possible protective measures,
before proceeding on warnings and instructions to operators.
2.4
Presumption of Conformity
In the Simple Pressure Vessels Directive the “presumption of conformity”
and “harmonised standards” are introduced in Article 5:
Article 5
1. Member States shall presume that vessels bearing the ‘CE’ marking
comply with all the provisions of this Directive.
Conformity of vessels with the national standards which transpose the
harmonised standards, the reference numbers of which have been
published in the Official Journal of the European Union, shall result in a
presumption of conformity to the essential safety requirements set
out in Annex I.
Member States shall publish the reference numbers of such national
standards.
2. Member States shall presume that vessels for which the standards referred to in the second subparagraph of paragraph 1 do not exist or in
respect of which the manufacturer has not applied or has only partially
applied such standards, comply with the essential safety requirements
set out in Annex I, where, after receipt of an EC type-examination cer-
46
tificate, their conformity with the approved model has been certified by
the affixation of the ‘CE’ marking.
If applying harmonised standards, the manufacturer benefits from the
“presumption of conformity”. That means that he can assume that his
product fulfils all relevant essential requirements of the Simple Pressure
Vessels Directive, if the standard covers all relevant essential safety
requirements and if the manufacturer has applied the whole standard. This
implies the following great advantage: If market surveillance authorities doubt
that the pressure vessel is in compliance with the Directive it is up to the
authorities to proof that there are any deviations.
2.5
Harmonised European Standards
An important principle of the New Approach is the fact, that the manufacturer
is completely free to choose the technical solutions, he wants to apply for his
product. In principle the essential safety requirements of a Directive are
sufficient to decide which technical solution would fulfil the requirements. It is
up to the manufacturer to decide if he wants to work without any standard or
if he wants to use a factory standard, a national standard, a European
standard or an International Standard or whatsoever other solution. But this is
true only in so far as the manufacturer can demonstrate that the solution he
applied is oriented at the state of the art and reduces the existing risk in an
appropriate way and hence that his product fulfils all relevant essential
requirements of Annex I. This freedom in choosing the appropriate technical
solution is an important element in the support of technical development and
innovation.
But with the New Approach also the element of “Harmonised European
Standards” was introduced (For further details see Chapter II, 4.4). A harmonised European standard is developed with the aim to cover the essential
safety requirements of the directive, it is developed for. Designing and manufacturing according to these standards is the most direct and probably easiest
way of demonstrating compliance with the essential safety requirements.
But it must be emphasised, that a harmonised standard does not necessarily cover all essential requirements. In that case it is the obligation of
the manufacturer to use other relevant technical specifications in order to
meet all the relevant essential requirements of the Directive. Nowadays the
European standards organisations are requested to publish with the harmonised standard an “Annex ZA” from which the user of the standard can recognise which essential requirements of a directive are of relevance for the
product described in the standard and which of those requirements are covered by the standard. Although this will be the case in the vast majority of
standards, the manufacturer must be aware that there might be some misleading deviations:
47
There might be the possibility that a solution given in a standard and listed in
Annex ZA had been considered by the Commission or by a Member State to be
inadequate to comply with the essential safety requirements of the Directive.
In such cases a formal objection can be formulated against the whole standard or against parts of the standard. As a result of such a formal objection it
is possible that the whole standard has been removed from the list of harmonised European Standards, published in the Official Journal. Another possibility
is that there is only published a note, that a certain part of the standard is not
in conformity with a certain requirement of the directive and therefore does
not give the presumption of conformity. But despite the removal of the standard from the list in the Official Journal and despite a comment in the Official
Journal that certain parts of the standard are not in conformity with the requirements of the Directive, the harmonised Standard is still in existence and
still “valid”. The user of the standard does not recognise in the standard or in
the Annex ZA of the standard, if for the standard or for certain parts of the
standard the presumption of conformity has been withdrawn. This means that
if the manufacturer would produce according to this standard, he certainly
would not fulfil the requirements of the Directive for the aspect in question.
The only possibility for the manufacturer to minimize this risk is to regularly
visit the following site
http://www.newapproach.org/Directives/DirectiveList.asp
from where the list with the references of harmonised standards for Simple
Pressure vessels can be accessed and to check in this list if there are any restrictions published for the standards he wants to apply.
As said before, the manufacturer is completely free to choose the technical solution he wants to apply for his pressure equipment. But if the manufacturer
chooses not to apply harmonised standards it is up to him to give, in the case
of doubts, proof of the conformity of his product with the relevant essential
requirements. The same applies if he uses only a part of a harmonised standard. In this case the presumption of conformity exists only to the extent that
he has used the standard and that the standard covers the essential requirements of the directive.
2.5.1
Harmonised European Standards for Simple Pressure Vessels
In the field of simple pressure vessels the following 15 valid standards were
published in the Official Journal on 28th February 2009. These standards can
be grouped in four categories:
1. Standards for design
EN 286-1:1998/AC:2002
CEN EN 286-2:1992
Simple unfired pressure vessels designed to contain air or nitrogen
— Part 2:
48
Pressure vessels for air braking and auxiliary systems for motor vehicles and their trailers
—
EN 286-2:1992/AC:1992
CEN EN 286-3:1994
Simple unfired pressure vessels designed to contain air or nitrogen
— Part 3:
Steel pressure vessels designed for air braking equipment and auxiliary pneumatic equipment for railway rolling stock
—
CEN EN 286-4:1994
Simple unfired pressure vessels designed to contain air or nitrogen
— Part 4:
Aluminium alloy pressure vessels designed for air braking equipment
and auxiliary pneumatic equipment for railway rolling stock
2. Standards for welding
CEN EN 287-1:2004
Qualification test of welders — Fusion welding — Part 1: Steels
CEN EN ISO 15614-1:2004
Specification and qualification of welding procedures for metallic materials —
Welding procedure test — Part 1: Arc and gas welding of steels and
arc welding of nickel and nickel alloys (ISO 15614-1:2004)
—
CEN EN ISO 15614-2:2005
Specification and qualification of welding procedures for metallic materials —
Welding procedure test — Part 2: Arc welding of aluminium and its
alloys (ISO 15614-2:2005)
—
CEN EN 1011-1:1998
Welding — Recommendations for welding of metallic materials —
Part 1:
General guidance for arc welding
3. Standards for testing
EN 287-1:2004/AC:2004
CEN EN 571-1:1997
Non destructive testing — Penetrant testing — Part 1: General principles
—
CEN EN 583-1:1998
Non-destructive testing — Ultrasonic examination — Part 1: General
principles
—
CEN EN 970:1997
49
Non-destructive examination of fusion welds — Visual examination
—
CEN EN 1290:1998
Non-destructive examination of welds — Magnetic particle examination of welds
—
CEN EN 1330-3:1997
Non-destructive testing — Terminology — Part 3: Terms used in industrial radiographic testing
—
CEN EN 1714:1997
Non-destructive examination of welds — Ultrasonic examination of
welded joints
—
CEN EN 12062:1997
Non-destructive examination of welds — General rules for metallic
materials
4. Standards for material
CEN EN 10207:2005
Steels for simple pressure vessels — Technical delivery requirements for plates, strips and bars
The bibliographic data of the Harmonised European Standards are regularly
published in the Official Journal of the European Union. A recent publication
from 28.02.2009 can be accessed via the following internet link:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2009:049:0003:0005:EN:PDF
A regular update of the list as well as a list of the present standardisation
activities can be accessed via the following internet link:
http://www.newapproach.org/Directives/DirectiveList.asp
2.5.2 Harmonised European Standards for Simple Pressure Vessels
adopted as Ukrainian Standards
In Ukraine some of the Harmonised European Standards were adopted as
Ukrainian standards. A list of those harmonised European Standards
adopted as Ukrainian Standards is given on the internet site of DSSU. To
access that list, the following internet-link should be followed:
http://www.dssu.gov.ua/control/uk/publish/category/main?cat_id=134398
From that page the ZIP-File with standards must be opened where the
standards for simple pressure vessels can be found. With the date of 1st July
2010 the following list of adopted standards was received, which covers all
standards for test procedures published in the Official Journal of the EU:
50
List of Ukrainian Standards Adopted as Identical to EN
EN 571-1:1997
EN 583-1:1998
EN 1290:1998
EN 1330-1:1998
EN 1714:1997
EN 12062:1997
2.6
ДСТУ EN 571-1–2001
ДСТУ EN 583-1–2001
ДСТУ EN 1290–2002
ДСТУ EN 1330-1:2008
ДСТУ EN 1714:2005
ДСТУ EN 12062:2005
19.100
19.100
25.160.40
01.040.19; 19.100
25.160.40
25.160.40
IDT
IDT
IDT
IDT
IDT
IDT
Certification procedures
The application of harmonised standards has in addition to the presumption of
conformity also consequences with respect to the certification procedures to
be applied. Details are given in the following chapters.
2.6.1
Certification prior to production
Prior to production of pressure vessels the manufacturer is required to get in
touch with an inspection body and have either examined by the body the
“design and manufacturing schedule”, leading to a “certificate of
adequacy” if the schedule is satisfactory, or have carried out the “EC typeexamination” at a prototype vessel. Which of the two possible procedures
must be applied depends on the question if harmonised standards were used
completely or only partially or not at all. For details see Article 8 (1) (2):
Article 8
1. Prior to production of pressure vessels of which the product of PS x V
exceeds 50 bar.l, manufactured in accordance with the harmonised standards referred to in Article 5(1), the manufacturer, or his authorised representative established within the Community, shall at his own choice either:
(a) inform an approved inspection body as referred to in Article 9, which,
after examining the design and manufacturing schedule referred to in point
3 of Annex II, shall draw up a certificate of adequacy attesting that the
schedule is satisfactory; or
(b) submit a prototype vessel for the EC type-examination referred to in
Article 10.
2. Prior to production of pressure vessels of which the product of PS x V
exceeds 50 bar.l, not manufactured, or manufactured only partly, in accordance with the harmonised standards referred to in Article 5(1), the manufacturer, or his authorised representative established within the Community, shall submit a prototype vessel for the EC type-examination referred
to in Article 10.
51
This means that prior to production the manufacturer, completely applying
harmonised standards, is free to choose between the two procedures described in Article 8(1)(a) respectively Article 8(1)(b). Whereas the manufacturer, applying harmonised standards only partly or not at all, is bound to apply the procedure described in Article 8(1)(b) and must submit a prototype
vessel to the inspection body for EC type-examination.
2.6.1.1
The certificate of adequacy
The procedure leading to a certificate of adequacy is the following: The
manufacturer must approach an approved inspection body (often called
notified body), which has been notified by a Member State according to Article
9 of this Directive. He must transmit to the approved inspection body the
“design and manufacturing schedules” as described in Annex II (3) and cited
hereunder:
Annex II (3) DESIGN AND MANUFACTURING SCHEDULES
The design and manufacturing schedules must contain a description of the
techniques and operations employed in order to meet the essential safety
requirements set out in Annex I or the harmonised standards referred to in
Article 5(1), and in particular:
(a) a detailed manufacturing drawing of the vessel type;
(b) the instructions;
(c) a document describing:
— the materials selected,
— the welding processes selected,
— the checks selected,
— any pertinent details as to the vessel design.
When the procedures laid down in Articles 11 to 14 are applied, the schedule must also include:
(a) the certificates relating to the suitable qualification of the welding
operations and of the welders or operators;
(b) the inspection slip for the materials used in the manufacture of parts
and assemblies contributing to the strength of the pressure vessel;
(c) a report on the examinations and tests performed or a description of
the proposed checks.
The approved inspection body will examine the design and manufacturing
schedules and if the results are positive the body will issue a certificate of
adequacy, attesting that the schedule is satisfactory.
52
2.6.1.2
The EC type-examination
Within the EC type-examination an approved inspection body examines a
prototype vessel and, if the result is positive, ascertains that it fulfils all
requirements of the directive, relevant for this type of vessel. All details are
described in Article 10, cited hereunder. It focuses on the following topics:
 How a manufacturer must apply for an EC type-examination,
 How the inspection body must perform the EC type-examination,
 Under which conditions an EC type-examination certificate will be issued
by the inspection body
 What the consequences are if an inspection body refuses to issue a
certificate or if he is obliged to withdraw a certificate.
Article 10
1. EC type-examination is the procedure whereby an approved inspection
body ascertains and certifies that a prototype vessel satisfies the provisions
of this Directive which apply to it.
2. The application for EC type-examination shall be lodged by the manufacturer or by his authorised representative with a single approved inspection
body in respect of a prototype vessel or of a prototype representing a family of vessels. That authorised representative must be established in the
Community. The application shall include:
(a) the name and address of the manufacturer or of his authorised representative and the place of manufacture of the vessels;
(b) the design and manufacturing schedule referred to in point 3 of Annex
II.
It shall be accompanied by a vessel which is representative of the production envisaged.
3. The approved inspection body shall carry out the EC type-examination in
the manner referred to in the second and third subparagraphs.
It shall examine not only the design and manufacturing schedule in order
to check its conformity, but also the vessel submitted.
When examining the vessel, the body shall:
(a) verify that the vessel has been manufactured in conformity with the design and manufacturing schedule and may safely be used under its intended working conditions;
(b) perform appropriate examinations and tests to check that the vessel
complies with the essential requirements applicable to it.
4. If the prototype complies with the provisions applicable to it the approved inspection body shall draw up an EC type-examination certificate
which shall be forwarded to the applicant. That certificate shall state the
conclusions of the examination, indicate any conditions to which its issue
may be subject and be accompanied by the descriptions and drawings necessary for identification of the approved prototype.
53
The Commission, the other approved inspection bodies and the other Member States may obtain a copy of the certificate and, on a reasoned request,
a copy of the design and manufacturing schedule and the reports on the
examinations and tests carried out.
5. An approved inspection body which refuses to issue an EC typeexamination certificate shall so inform the other approved inspection bodies.
An approved inspection body which withdraws an EC type-examination certificate shall so inform the Member State which approved it. The latter shall
inform the other Member States and the Commission thereof, giving the
reasons for the decision.
2.6.2
Procedures to be applied prior to placing vessels on the market
Regardless whether harmonised standards were applied or not, vessels must
prior to their placing on the market undergo the “EC verification” or the “EC
declaration of conformity”. Which procedure must be applied depends on
the question if the product PS x V does exceed 3 000 bar∙l or does not. For details see Article 8(3), cited hereunder:
Article 8 (3) Vessels manufactured in accordance with the harmonised
standards referred to in Article 5(1) or with the approved prototype shall,
prior to their being placed on the market, be subject:
(a) to the EC verification referred to in Article 11 where the product of PS x
V exceeds 3 000 bar.l;
(b) at the choice of the manufacturer, where the product of PS x V does
not exceed 3 000 bar.l but exceeds 50 bar.l, either:
(i) to the EC declaration of conformity referred to in Article 12; or
(ii) to the EC verification referred to in Article 11.
This means that prior to their placing on the market for vessels with the
product PS x V ≤ 3000 bar∙l the manufacturer can choose between the “EC
declaration of conformity” and the “EC verification”, whereas for vessels with
the product PS x V > 3000 bar∙l the manufacturer must apply the “EC
verification”.
2.6.2.1
The EC verification
With the EC verification the manufacturer ensures and declares that the
vessels, a batch of which has been checked by an approved inspection body,
are conform to the type described in the EC type-examination certificate or to
the design and manufacturing schedule. All details are described in Article 11
cited hereunder. Article 11 deals especially with

The manufacturing process

The CE marking and the conformity declaration
54

The examinations and tests to be carried out by the approved inspection
body on batches of vessels

The identification of the approved inspection body, by means of the
identification number next to the CE marking
Article 11
1. EC verification is the procedure whereby a manufacturer or his authorised representative established within the Community ensures and declares
that the vessels which have been checked in accordance with paragraph 3
are in conformity with the type described in the EC type-examination certificate or with the design and manufacturing schedule referred to in point
3 of Annex II having received a certificate of adequacy.
2. The manufacturer shall take all necessary measures for the manufacturing process to ensure that the vessels conform to the type described in the
EC type-examination certificate or to the design and manufacturing schedule referred to in point 3 of Annex II. The manufacturer or his authorised
representative established within the Community shall affix the ‘CE’ marking to each vessel and draw up a declaration of conformity.
3. The approved inspection body shall carry out the appropriate examinations and tests in order to check the conformity of the vessels with the requirements of this Directive by examination and testing of vessels in accordance with the second to tenth subparagraphs.
The manufacturer shall present his vessels in the form of uniform batches
and shall take all necessary measures in order that the manufacturing
process ensures the uniformity of each batch produced.
Those batches shall be accompanied by the EC type-examination certificate
referred to in Article 10 or, where the vessels are not manufactured in accordance with an approved prototype, by the design and manufacturing
schedule referred to in point 3 of Annex II. In the latter case the approved
inspection body shall, prior to EC verification, examine the schedule in order to certify its conformity.
When a batch is examined, the approved inspection body shall ensure that
the vessels have been manufactured and checked in accordance with the
design and manufacturing schedule, and shall perform a hydrostatic test or
a pneumatic test of equivalent effect on each vessel in the batch at a pressure Ph equal to 1,5 times the vessel’s design pressure in order to check its
soundness. The pneumatic test shall be subject to acceptance of the test
safety procedures by the Member State in which the test is performed.
Moreover, the approved inspection body shall carry out tests on test-pieces
taken from a representative production test-piece or from a vessel, as the
manufacturer chooses, in order to examine the weld quality. The tests shall
be carried out on longitudinal welds. However, where differing weld techniques are used for longitudinal and circular welds, the tests shall be repeated on the circular welds.
For the vessels referred
pieces shall be replaced
dom from each batch in
safety requirements set
to in point 2.1.2 of Annex I, these tests on testby a hydrostatic test on five vessels taken at ranorder to check that they conform to the essential
out in point 2.1.2 of Annex I.
55
In the case of accepted batches, the approved inspection body shall affix
its identification number, or cause that number to be affixed, to each vessel and shall draw up a written certificate of conformity relating to the tests
carried out. All vessels in the batch may be placed on the market except
for those which have not successfully undergone a hydrostatic test or a
pneumatic test.
If a batch is rejected, the approved inspection body shall take appropriate
measures to prevent the placing on the market of that batch. In the event
of frequent rejection of batches, the approved inspection body may suspend the statistical verification.
The manufacturer may, under the responsibility of the approved inspection
body, affix the latter’s identification number during the manufacturing
process.
The manufacturer or his authorised representative must be able to supply
on request the approved inspection body’s certificates of conformity referred to in the seventh subparagraph.
2.6.2.2
The EC declaration of conformity
The EC declaration of conformity comprises a set of 3 Articles 12, 13 and 14,
cited hereunder. According to Article 12 (1) the manufacturer must affix the
CE marking to all vessels, for which he declares conformity with the “design
and manufacturing schedule” or with an “approved prototype”.
By this EC declaration of conformity procedure, the manufacturer of vessels
with the product PS x V > 200 bar∙l, becomes subject to “EC
surveillance”, described in the second paragraph of Article 14
Article 12
1. A manufacturer fulfilling the obligations arising under Article 13 shall affix the ‘CE’ marking provided for in Article 16 to vessels which he declares
to be in conformity with:
(a) the design and manufacturing schedule referred to in point 3 of Annex
II in respect of which a certificate of adequacy has been drawn up; or
(b) an approved prototype.
2. By the EC declaration of conformity procedure the manufacturer becomes subject to EC surveillance, in cases where the product of PS x V exceeds 200 bar.l.
The purpose of EC surveillance is to ensure, as required by the second
paragraph of Article 14, that the manufacturer duly fulfils the obligations
arising under Article 13(2). Surveillance shall be performed by the approved inspection body which issued the EC type-examination certificate
referred to in the first subparagraph of Article 10(4) where the vessels
have been manufactured in accordance with an approved prototype or, if
56
this is not the case, by the approved body to which the design and manufacturing schedule was sent in accordance with Article 8(1)(a).
Before starting with the manufacturing process, the manufacturer applying the
EC declaration of conformity procedure must give according to Article 13 to
the approved inspection body some relevant information concerning a document describing the manufacturing processes and all of the predetermined
systematic measures taken to ensure conformity of the pressure vessels to the
harmonised standards or the approved prototype. It shall include:

a description of the means of manufacture and checking appropriate to
the construction of the vessels;

the appropriate examinations and tests to be carried out during manufacture,

an undertaking to carry out the examinations and tests in accordance
with the inspection document,

the addresses of the places of manufacture and storage and

the date on which manufacture is to commence.
If the product PS x V > 200 bar∙l, additional information and authorised access
to the place of manufacture and storage is to be given to the body responsible
for EC surveillance. All requirements can be found in Article 13, cited
hereunder.
Article 13
1. Where a manufacturer makes use of the procedure referred to in Article
12, he shall, before commencing manufacture, send the approved inspection body which issued the EC type-examination certificate or the certificate
of adequacy a document describing the manufacturing processes and all of
the predetermined systematic measures taken to ensure conformity of the
pressure vessels to the standards referred to in Article 5(1) or the approved prototype.
2. The document referred to in paragraph 1 shall include:
(a) a description of the means of manufacture and checking appropriate to
the construction of the vessels;
(b) an inspection document describing the appropriate examinations and
tests to be carried out during manufacture, together with the procedures in
respect thereof and the frequency with which they are to be performed;
(c) an undertaking to carry out the examinations and tests in accordance
with the inspection document referred to in point (b) and to have a hydrostatic test or, subject to the agreement of the Member State, a pneumatic
test carried out on each vessel manufactured at a test pressure equal to
1,5 times the design pressure; those examinations and tests shall be carried out under the responsibility of qualified staff who are sufficiently independent from production personnel, and shall be the subject of a report;
57
(d) the addresses of the places of manufacture and storage and the date
on which manufacture is to commence.
3. When the product of PS x V exceeds 200 bar.l, manufacturers shall
authorise access to the said places of manufacture and storage by the body
responsible for EC surveillance, for inspection purposes, and shall allow
that body to select sample vessels and shall provide it with all necessary
information, and in particular:
(a) the design and manufacturing schedule;
(b) the inspection report;
(c) the EC type-examination certificate or certificate of adequacy, where
appropriate;
(d) a report on the examinations and tests carried out.
According to Article 14 the approved inspection body must, before the beginning of the manufacturing process, examine the documents, send in according
to the requirements of Article 13 by the manufacturer, and certify their conformity. Article 14 also refers to the duties of the approved inspection body in
the context of EC surveillance, relevant for manufacturers of vessels with PS x
V > 200 bar l.
Article 14
The approved inspection body which issued the EC type-examination certificate or certificate of adequacy shall, before the date on which any
manufacture begins, examine both the document referred to in Article
13(1) and the design and manufacturing schedule referred to in point 3 of
Annex II, in order to certify its conformity, where vessels are not manufactured in accordance with an approved prototype.
In addition, where the product of PS x V exceeds 200 bar.l, that body shall
during manufacture:
(a) ensure that the manufacturer actually checks series-produced vessels
in accordance with Article 13(2)(c);
(b) take random samples at the places of manufacture or at the place of
storage of vessels for inspection purposes.
The approved inspection body shall supply the Member State which approved it and, on request, the other approved inspection bodies, the other
Member States and the Commission, with a copy of the inspection report.
2.6.2.3
CE Marking
In Article 16 details on how to apply the CE marking are given. The proper
design of the CE marking can be taken from Annex II. It is important to
notice, that the CE marking shall be followed by the “identification number” of
the approved inspection body who carried out the “EC verification” or “EC
surveillance”. It must also be emphasized that according to Article 15 the
unduly application of the CE marking to products which are not conform with
58
the requirements of this directive, may lead to a restriction or prohibition of
the placing on the market of the product in question or even to a withdrawal of
the product from the market.
Article 16
1. The ‘CE’ marking and the inscriptions provided for in point 1 of Annex II,
shall be affixed in a visible, legible and indelible form to the vessel or to a
data plate attached to the vessel in such a way that it cannot be removed.
The ‘CE’ marking shall consist of the initials ‘CE’ in the form shown in the
specimen in point 1.1 of Annex II. The ‘CE’ marking shall be followed by
the identification number referred to in Article 9(1) of the approved inspection body responsible for ‘CE’ verifications or ‘CE’ surveillance.
2. The affixing on the vessels of markings which are likely to deceive third
parties as to the meaning and form of the ‘CE’ marking shall be prohibited.
Any other marking may be affixed to the vessels or the data plate provided
that the visibility and legibility of the ‘CE’ marking are not thereby reduced.
2.6.3
How to Find the Right Approved Inspection Body?
It is advisable to contact an approved inspection body as early as possible and
to fix together with him the terms on the basis of which the EC typeexamination, the EC verification, the EC surveillance or the issuing of the
certificate of adequacy will be performed. E.g. to agree on the language of the
files and the correspondence, the inspection body can accept.
In principle the manufacturer is free to choose an inspection body independent
of the country in which the inspection body is based. At that point it must be
emphasised that bodies have been notified even from countries outside the
European Union (e.g. Japan, Turkey, USA).
An important help to find out the appropriate inspection body is NANDO the
New Approach Notified and Designated Organisations Information
System on the server of the European Commission, DG Enterprise and
Industry. NANDO can be accessed via the following internet-link:
http://ec.europa.eu/enterprise/newapproach/nando/
NANDO offers many possibilities: One can find out which institutions are
notified from which country for which Directive. The notified institutions deliver
detailed information on the categories of equipment or on the kind of
assessments for which they have been notified.
Of course it is of great help if the communication with the inspection body can
be in the language of the manufacturer and if the inspection body can accept
all documents in the language of the manufacturer. This is not always the
case, especially if the manufacturer is based in a country outside the European
Union, which has not notified a body for the product in question. But there are
59
sometimes other possibilities to overcome this problem:
In Ukraine, some institutions are in the position to make all preparatory work
and to carry out the necessary assessments, on the basis of which approved
inspection body, based in the European Union and having a co-operation
agreement with one of the institutions, can issue the necessary documents
needed for placing a simple pressure vessel onto the European market.
As one example given, a number of Ukrainian test institutions is organised in
the “Cert-Centre group”, having agreements with bodies notified in the
European Union, and which can be approached via the following internet link:
http://www.cert-centre.com/html/group_ru.htm
60
VI
Annex 1
DIRECTIVE 2009/105/EC OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 16 September 2009 relating to
simple pressure vessels
(codified version)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular
Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee13,
Acting in accordance with the procedure laid down in Article 251 of the Treaty14,
Whereas:
(1) Council Directive 87/404/EEC of 25 June 1987 on the harmonization of the laws of
the Member States relating to simple pressure vessels 15 has been substantially
amended several times16. In the interests of clarity and rationality the said Directive
should be codified.
(2) Member States have the responsibility of ensuring the safety on their territory of
persons, domestic animals and property with regard to the hazards resulting from the
leakage or bursting of simple pressure vessels.
(3) In each Member State, mandatory provisions define in particular the safety level
required of simple pressure vessels by specifying design and operating characteristics,
conditions of installation and use and inspection procedures before and after the placing on the market. These mandatory provisions do not necessarily lead to different
safety levels from one Member State to another but do, by their disparity, hinder
trade within the Community.
(4) This Directive should therefore contain only mandatory and essential requirements. To facilitate proof of conformity with the essential requirements, it is necessary
to have harmonised standards at Community level, in particular as to the design, operation and installation of simple pressure vessels, so that products complying with
them may be assumed to conform to the safety requirements. These standards harmonised at Community level are drawn up by private bodies and should remain nonmandatory texts. For that purpose, the European Committee for Standardisation
(CEN), the European Committee for Electrotechnical Standardisation (Cenelec) and the
European Telecommunications Standards Institute (ETSI) are recognised as the competent bodies for the adoption of harmonised standards in accordance with the general
13
OJ C 27, 3.2.2009, p. 41.
14
Opinion of the European Parliament of 21 October 2008 (not yet published in the Official Journal)
and Council Decision of 13 July 2009.
15
OJ L 220, 8.8.1987, p. 48.
16
See Annex IV, Part A.
61
guidelines17 for cooperation between the Commission, the European Free Trade Association (EFTA) and those three bodies signed on 28 March 2003.
(5) The Council has already adopted a series of Directives designed to remove technical barriers to trade in accordance with the principles established in its Resolution of 7
May 1985 on a new approach to technical harmonisation and standards 18 ; each of
those Directives provides for the affixing of the ‘CE’ marking. The Commission, in its
Communication of 15 June 1989 on a global approach to certification and testing 19,
proposed that common rules be drawn up concerning a ‘CE’ marking with a single design. The Council, in its Resolution of 21 December 1989 on a global approach to conformity assessment20, approved as a guiding principle the adoption of a consistent approach such as this with regard to the use of the ‘CE’ marking. The two basic elements
of the new approach which should be applied are the essential requirements and the
conformity assessment procedures.
(6) A check on compliance with the relevant technical requirements is necessary in order to provide effective protection for users and third parties. The existing inspection
procedures differ from one Member State to another. In order to avoid multiple inspections, which are in effect barriers to the free movement of vessels, arrangements
should be made for the mutual recognition of inspection procedures by the Member
States. In order to facilitate the mutual recognition of inspection procedures, Community procedures should be established as well as the criteria for appointing the bodies
responsible for carrying out tests, surveillance and verification.
(7) The presence on a simple pressure vessel of the ‘CE’ marking should raise a presumption that it satisfies the provisions of this Directive and should therefore make it
unnecessary, upon the importation and putting into service of the vessel, to repeat the
inspections already carried out. Nevertheless simple pressure vessels might represent
a safety hazard. Provision should therefore be made for a procedure to reduce this
hazard.
(8) This Directive should be without prejudice to the obligations of the Member States
relating to the time limits for transposition into national law and application of the Directives set out in Annex IV, Part B,
HAVE ADOPTED THIS DIRECTIVE:
17
18
19
20
OJ C 91, 16.4.2003, p. 7.
OJ C 136, 4.6.1985, p. 1.
OJ C 267, 19.10.1989, p. 3.
OJ C 10, 16.1.1990, p. 1.
62
CHAPTER I
SCOPE, DEFINITIONS, PLACING ON THE MARKET AND FREE MOVEMENT
Article 1
1. This Directive applies to simple pressure vessels manufactured in series.
2. The following vessels shall be excluded from the scope of this Directive:
(a) vessels specifically designed for nuclear use, failure of which may cause an
emission of radioactivity;
(b) vessels specifically intended for installation in or the propulsion of ships and
aircraft;
(c) fire extinguishers.
3. For the purposes of this Directive the following definitions shall apply:
(a) ‘simple pressure vessel’ or ‘vessel’ means any welded vessel subjected to an internal gauge pressure greater than 0,5 bar which is intended to contain air or nitrogen
and which is not intended to be fired.
The parts and assemblies contributing to the strength of the vessel under pressure
shall be made either of non-alloy quality steel or of non-alloy aluminium or non-age
hardening aluminium alloys.
The vessel shall be made of either:
(i) a cylindrical part of circular cross-section closed by inwardly dished and/or
flat ends which revolve around the same axis as the cylindrical part; or
(ii) two dished ends revolving around the same axis.
The maximum working pressure of the vessel shall not exceed 30 bar and the product
of that pressure and the capacity of the vessel (PS x V) shall not exceed 10 000 bar∙l.
The minimum working temperature must be no lower than – 50 °C and the maximum
working temperature must not be higher than 300 °C for steel and 100 °C for aluminium or aluminium alloy vessels;
(b) a ‘harmonised standard’ means a technical specification (European standard or
harmonisation document) adopted by the European Committee for Standardisation
(CEN), the European Committee for Electrotechnical Standardisation (CENELEC) or the
European Telecommunications Standards Institute (ETSI) or by two or three of those
bodies upon a remit from the Commission in accordance with Directive 98/34/EC of
the European Parliament and of the Council of 22 June 1998 laying down a procedure
for the provision of information in the field of technical standards and regulations and
of rules on Information Society services 21 and the general guidelines for cooperation
between the Commission, the European Free Trade Association (EFTA) and those three
bodies signed on 28 March 2003.
21
OJ L 204, 21.7.1998, p. 37.
63
Article 2
1. Member States shall take all necessary steps to ensure that the vessels may be
placed on the market and put into service only if they do not compromise the safety of
persons, domestic animals or property when properly installed and maintained and
used for the purposes for which they are intended.
2. The provisions of this Directive shall not affect the right of Member States to specify
— with due observance of the Treaty — the requirements they deem necessary in order to ensure that workers are protected when using vessels, provided it does not
mean that those vessels are modified in a way unspecified in this Directive.
Article 3
1. Vessels in respect of which the product of PS x V exceeds 50 bar∙l must satisfy the
essential safety requirements set out in Annex I.
2. Vessels in respect of which the product of PS x V is 50 bar∙l or less must be manufactured in accordance with sound engineering practice in one of the Member States
and bear markings as laid down in point 1 of Annex II, with the exception of the ‘CE’
marking referred to in Article 16.
Article 4
Member States shall not impede the placing on the market and the putting into service
in their territory of vessels which satisfy the requirements of this Directive.
Article 5
1. Member States shall presume that vessels bearing the ‘CE’ marking comply with all
the provisions of this Directive.
Conformity of vessels with the national standards which transpose the harmonised
standards, the reference numbers of which have been published in the Official Journal
of the European Union, shall result in a presumption of conformity to the essential
safety requirements set out in Annex I.
Member States shall publish the reference numbers of such national standards.
2. Member States shall presume that vessels for which the standards referred to in the
second subparagraph of paragraph 1 do not exist or in respect of which the manufacturer has not applied or has only partially applied such standards, comply with the essential safety requirements set out in Annex I, where, after receipt of an EC typeexamination certificate, their conformity with the approved model has been certified
by the affixation of the ‘CE’ marking.
3. Where vessels are subject to other Directives covering other aspects and which also
provide for the affixing of the ‘CE’ marking, the latter shall indicate that the vessels in
question are also presumed to conform to the provisions of those other Directives.
64
However, where one or more of those Directives allow the manufacturer, during a
transitional period, to choose which arrangements to apply, the ‘CE’ marking shall indicate conformity only to the Directives applied by the manufacturer. In this case, particulars of the Directives applied, as published in the Official Journal of the European
Union, shall be given in the documents, notices or instructions required by the Directives and accompanying such vessels.
Article 6
Where a Member State or the Commission considers that the harmonised standards
referred to in Article 5(1) do not entirely meet the essential safety requirements set
out in Annex I, the Commission or the Member State concerned shall bring the matter
before the standing committee set up under Article 5 of Directive 98/34/EC, hereinafter referred to as ‘the committee’, giving the reasons therefore.
The committee shall deliver an opinion without delay.
In the light of the committee’s opinion, the Commission shall inform the Member
States whether or not it is necessary to withdraw those standards from the publications referred to in Article 5(1).
Article 7
1. Where a Member State finds that vessels bearing the ‘CE’ marking and used in accordance with their intended purpose might compromise the safety of persons, domestic animals or property, it shall take all appropriate measures to withdraw those
products from the market or to prohibit or restrict their being placed on the market.
The Member State concerned shall immediately inform the Commission of any such
measure, indicating the reasons for its decision, and in particular whether nonconformity is due to:
(a) failure to meet the essential safety requirements set out in Annex I, where
the vessel does not meet the harmonised standards referred to in Article 5(1);
(b) incorrect application of the harmonised standards referred to in Article 5(1);
(c) shortcomings in the harmonised standards referred to in Article 5(1).
2. The Commission shall enter into consultation with the parties concerned as soon as
possible. Where, after such consultation, the Commission finds that any measure as
referred to in paragraph 1 is justified, it shall immediately so inform the Member State
that took the action and the other Member States.
Where the decision referred to in paragraph 1 is attributed to shortcomings in the
standards, the Commission, after consulting the parties concerned, shall bring the
matter before the committee within two months if the Member State which has taken
the measures intends to maintain them and shall set in motion the procedure referred
to in Article 6.
3. Where a vessel which does not comply bears the ‘CE’ marking, the competent
Member State shall take appropriate action against whomsoever has affixed the marking and shall inform the Commission and the other Member States thereof.
4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of the procedure referred to in paragraphs 1, 2 and 3.
65
CHAPTER II
CERTIFICATION
SECTION 1
Certification procedures
Article 8
1. Prior to production of pressure vessels of which the product of PS x V exceeds 50
bar∙l, manufactured in accordance with the harmonised standards referred to in Article
5(1), the manufacturer, or his authorised representative established within the Community, shall at his own choice either:
(a) inform an approved inspection body as referred to in Article 9, which, after
examining the design and manufacturing schedule referred to in point 3 of Annex II, shall draw up a certificate of adequacy attesting that the schedule is
satisfactory; or
(b) submit a prototype vessel for the EC type-examination referred to in Article
10.
2. Prior to production of pressure vessels of which the product of PS x V exceeds 50
bar∙l, not manufactured, or manufactured only partly, in accordance with the harmonised standards referred to in Article 5(1), the manufacturer, or his authorised representative established within the Community, shall submit a prototype vessel for the EC
type-examination referred to in Article 10.
3. Vessels manufactured in accordance with the harmonised standards referred to in
Article 5(1) or with the approved prototype shall, prior to their being placed on the
market, be subject:
(a) to the EC verification referred to in Article 11 where the product of
PS x V exceeds 3 000 bar∙l;
(b) at the choice of the manufacturer, where the product of PS x V does not exceed 3 000 bar∙l but exceeds 50 bar∙l, either:
(i) to the EC declaration of conformity referred to in Article 12; or
(ii) to the EC verification referred to in Article 11.
4. The records and correspondence relating to the certification procedures referred to
in paragraphs 1, 2 and 3 shall be drafted in an official language of the Member State
in which the approved inspection body is established or in a language accepted by that
body.
Article 9
1. Member States shall notify the Commission and the other Member States of the approved inspection bodies which they have appointed to carry out the procedures referred to in Article 8(1), (2) and (3) together with the specific tasks which those bodies have been appointed to carry out and the identification numbers assigned to them
beforehand by the Commission. The Commission shall publish in the Official Journal of
the European Union a list of the notified bodies with their identification numbers and
the tasks for which they have been notified. The Commission shall ensure that this list
is kept up to date.
66
2. For the purposes of approval of the bodies referred to in paragraph 1, Member
States shall meet the minimum criteria set out in Annex III.
3. A Member State which has approved an inspection body shall withdraw approval if
it finds that the body no longer meets the minimum criteria set out in Annex III. It
shall immediately inform the Commission and the other Member States accordingly.
SECTION 2
EC type-examination
Article 10
1. EC type-examination is the procedure whereby an approved inspection body ascertains and certifies that a prototype vessel satisfies the provisions of this Directive
which apply to it.
2. The application for EC type-examination shall be lodged by the manufacturer or by
his authorised representative with a single approved inspection body in respect of a
prototype vessel or of a prototype representing a family of vessels. That authorised
representative must be established in the Community. The application shall include:
(a) the name and address of the manufacturer or of his authorised representative and the place of manufacture of the vessels;
(b) the design and manufacturing schedule referred to in point 3 of
Annex II.
It shall be accompanied by a vessel which is representative of the production envisaged.
3. The approved inspection body shall carry out the EC type-examination in the manner referred to in the second and third subparagraphs.
It shall examine not only the design and manufacturing schedule in order to check its
conformity, but also the vessel submitted.
When examining the vessel, the body shall:
(a) verify that the vessel has been manufactured in conformity with the design
and manufacturing schedule and may safely be used under its intended working conditions;
(b) perform appropriate examinations and tests to check that the vessel complies with the essential requirements applicable to it.
4. If the prototype complies with the provisions applicable to it the approved inspection body shall draw up an EC type-examination certificate which shall be forwarded to
the applicant. That certificate shall state the conclusions of the examination, indicate
any conditions to which its issue may be subject and be accompanied by the descriptions and drawings necessary for identification of the approved prototype.
The Commission, the other approved inspection bodies and the other Member States
may obtain a copy of the certificate and, on a reasoned request, a copy of the design
and manufacturing schedule and the reports on the examinations and tests carried
out.
5. An approved inspection body which refuses to issue an EC type-examination certificate shall so inform the other approved inspection bodies.
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An approved inspection body which withdraws an EC type-examination certificate shall
so inform the Member State which approved it. The latter shall inform the other Member States and the Commission thereof, giving the reasons for the decision.
SECTION 3
EC verification
Article 11
1. EC verification is the procedure whereby a manufacturer or his authorised representative established within the Community ensures and declares that the vessels which
have been checked in accordance with paragraph 3 are in conformity with the type
described in the EC type-examination certificate or with the design and manufacturing
schedule referred to in point 3 of Annex II having received a certificate of adequacy.
2. The manufacturer shall take all necessary measures for the manufacturing process
to ensure that the vessels conform to the type described in the EC type-examination
certificate or to the design and manufacturing schedule referred to in point 3 of Annex
II. The manufacturer or his authorised representative established within the Community shall affix the ‘CE’ marking to each vessel and draw up a declaration of conformity.
3. The approved inspection body shall carry out the appropriate examinations and
tests in order to check the conformity of the vessels with the requirements of this Directive by examination and testing of vessels in accordance with the second to tenth
subparagraphs.
The manufacturer shall present his vessels in the form of uniform batches and shall
take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced.
Those batches shall be accompanied by the EC type-examination certificate referred to
in Article 10 or, where the vessels are not manufactured in accordance with an approved prototype, by the design and manufacturing schedule referred to in point 3 of
Annex II. In the latter case the approved inspection body shall, prior to EC verification, examine the schedule in order to certify its conformity.
When a batch is examined, the approved inspection body shall ensure that the vessels
have been manufactured and checked in accordance with the design and manufacturing schedule, and shall perform a hydrostatic test or a pneumatic test of equivalent effect on each vessel in the batch at a pressure Ph equal to 1,5 times the vessel’s design
pressure in order to check its soundness. The pneumatic test shall be subject to acceptance of the test safety procedures by the Member State in which the test is performed.
Moreover, the approved inspection body shall carry out tests on test-pieces taken
from a representative production test-piece or from a vessel, as the manufacturer
chooses, in order to examine the weld quality. The tests shall be carried out on longitudinal welds. However, where differing weld techniques are used for longitudinal and
circular welds, the tests shall be repeated on the circular welds.
For the vessels referred to in point 2.1.2 of Annex I, these tests on test-pieces shall be
replaced by a hydrostatic test on five vessels taken at random from each batch in order to check that they conform to the essential safety requirements set out in point
2.1.2 of Annex I.
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In the case of accepted batches, the approved inspection body shall affix its identification number, or cause that number to be affixed, to each vessel and shall draw up a
written certificate of conformity relating to the tests carried out. All vessels in the
batch may be placed on the market except for those which have not successfully undergone a hydrostatic test or a pneumatic test.
If a batch is rejected, the approved inspection body shall take appropriate measures
to prevent the placing on the market of that batch. In the event of frequent rejection
of batches, the approved inspection body may suspend the statistical verification.
The manufacturer may, under the responsibility of the approved inspection body, affix
the latter’s identification number during the manufacturing process.
The manufacturer or his authorised representative must be able to supply on request
the approved inspection body’s certificates of conformity referred to in the seventh
subparagraph.
SECTION 4
EC declaration of conformity
Article 12
1. A manufacturer fulfilling the obligations arising under Article 13 shall affix the ‘CE’
marking provided for in Article 16 to vessels which he declares to be in conformity
with:
(a) the design and manufacturing schedule referred to in point 3 of Annex II in
respect of which a certificate of adequacy has been drawn up; or
(b) an approved prototype.
2. By the EC declaration of conformity procedure the manufacturer becomes subject to
EC surveillance, in cases where the product of PS x V exceeds 200 bar∙l.
The purpose of EC surveillance is to ensure, as required by the second paragraph of
Article 14, that the manufacturer duly fulfils the obligations arising under Article 13(2).
Surveillance shall be performed by the approved inspection body which issued the EC
type-examination certificate referred to in the first subparagraph of Article 10(4)
where the vessels have been manufactured in accordance with an approved prototype
or, if this is not the case, by the approved body to which the design and manufacturing schedule was sent in accordance with Article 8(1)(a).
Article 13
1. Where a manufacturer makes use of the procedure referred to in Article 12, he
shall, before commencing manufacture, send the approved inspection body which issued the EC type-examination certificate or the certificate of adequacy a document
describing the manufacturing processes and all of the predetermined systematic
measures taken to ensure conformity of the pressure vessels to the standards referred
to in Article 5(1) or the approved prototype.
2. The document referred to in paragraph 1 shall include:
(a) a description of the means of manufacture and checking appropriate to the
construction of the vessels;
69
(b) an inspection document describing the appropriate examinations and tests
to be carried out during manufacture, together with the procedures in respect
thereof and the frequency with which they are to be performed;
(c) an undertaking to carry out the examinations and tests in accordance with
the inspection document referred to in point (b) and to have a hydrostatic test
or, subject to the agreement of the Member State, a pneumatic test carried out
on each vessel manufactured at a test pressure equal to 1,5 times the design
pressure; those examinations and tests shall be carried out under the responsibility of qualified staff who are sufficiently independent from production personnel, and shall be the subject of a report;
(d) the addresses of the places of manufacture and storage and the date on
which manufacture is to commence.
3. When the product of PS x V exceeds 200 bar∙l, manufacturers shall authorise access
to the said places of manufacture and storage by the body responsible for EC surveillance, for inspection purposes, and shall allow that body to select sample vessels and
shall provide it with all necessary information, and in particular:
(a) the design and manufacturing schedule;
(b) the inspection report;
(c) the EC type-examination certificate or certificate of adequacy, where appropriate;
(d) a report on the examinations and tests carried out.
Article 14
The approved inspection body which issued the EC type-examination certificate or certificate of adequacy shall, before the date on which any manufacture begins, examine
both the document referred to in Article 13(1) and the design and manufacturing
schedule referred to in point 3 of Annex II, in order to certify its conformity, where
vessels are not manufactured in accordance with an approved prototype.
In addition, where the product of PS x V exceeds 200 bar∙l, that body shall during
manufacture:
(a) ensure that the manufacturer actually checks series-produced vessels in accordance with Article 13(2)(c);
(b) take random samples at the places of manufacture or at the place of storage of vessels for inspection purposes.
The approved inspection body shall supply the Member State which approved it and,
on request, the other approved inspection bodies, the other Member States and the
Commission, with a copy of the inspection report.
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CHAPTER III
‘CE’ MARKING AND INSCRIPTIONS
Article 15
Without prejudice to Article 7:
(a) where a Member State establishes that the ‘CE’ marking has been affixed unduly,
the manufacturer or his authorised representative established within the Community
shall be obliged to make the product conform with the provisions concerning the ‘CE’
marking and to end the infringement under the conditions imposed by that Member
State;
(b) where the non-conformity continues, the Member State must take all appropriate
measures to restrict or prohibit the placing on the market of the product in question or
to ensure that it is withdrawn from the market in accordance with the procedure laid
down in Article 7.
Article 16
1. The ‘CE’ marking and the inscriptions provided for in point 1 of Annex II, shall be
affixed in a visible, legible and indelible form to the vessel or to a data plate attached
to the vessel in such a way that it cannot be removed.
The ‘CE’ marking shall consist of the initials ‘CE’ in the form shown in the specimen in
point 1.1 of Annex II. The ‘CE’ marking shall be followed by the identification number
referred to in Article 9(1) of the approved inspection body responsible for ‘CE’ verifications or ‘CE’ surveillance.
2. The affixing on the vessels of markings which are likely to deceive third parties as
to the meaning and form of the ‘CE’ marking shall be prohibited. Any other marking
may be affixed to the vessels or the data plate provided that the visibility and legibility
of the ‘CE’ marking are not thereby reduced.
CHAPTER IV
FINAL PROVISIONS
Article 17
Any decision taken pursuant to this Directive which results in restrictions on the placing on the market or the putting into service of a vessel shall state the exact grounds
on which it is based. Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the judicial remedies available to
him under the laws in force in the Member State in question and of the time limits to
which such remedies are subject.
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Article 18
Member States shall communicate to the Commission the text of the main provisions
of national law which they adopt in the field covered by this Directive.
Article 19
Directive 87/404/EEC, as amended by the Directives listed in Annex IV, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time
limits for transposition into national law and application of the Directives set out in
Annex IV, Part B.
References to the repealed Directive shall be construed as references to this Directive
and shall be read in accordance with the correlation table in Annex V.
Article 20
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 21
This Directive is addressed to the Member States.
Done at Strasbourg, 16 September 2009.
For the European Parliament
For the Council
The President
The President
J. BUZEK
C. MALMSTRÖM
_________________
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ANNEX I
ESSENTIAL SAFETY REQUIREMENTS
(referred to in Article 3(1))
1. MATERIALS
Materials must be selected according to the intended use of the vessels and in accordance with points 1.1 to 1.4.
1.1. Pressurised parts
The materials referred to in Article 1 used for manufacturing the pressurised parts of
the vessels must be:
(a) capable of being welded;
(b) ductile and tough, so that a rupture at minimum working temperature does
not give rise to either fragmentation or brittle-type fracture;
(c) not adversely affected by ageing.
For steel vessels, the materials must in addition meet the requirements set out in
point 1.1.1 and, for aluminium or aluminium alloy vessels, those set out in point 1.1.2.
They must be accompanied by an inspection slip as described in Annex II, drawn up
by the producer of the materials.
1.1.1. Steel vessels
Non-alloy quality steels shall meet the following requirements:
(a) they must be non-effervescent and supplied after normalisation treatment,
or in an equivalent state;
(b) the content per product of carbon must be less than 0,25 % and that of
sulphur and phosphorus must each be less than 0,05 %;
(c) they must have the following mechanical properties per product:
— the maximum
580 N/mm 2 ,
tensile
strength
R
m,max
must
be
less
than
— the elongation after rupture must be:
— if test pieces are taken parallel to the direction of rolling:
thickness ≥ 3 mm: A ≥ 22 %,
thickness < 3 mm: A
80 mm
≥ 17 %,
— if test pieces are taken perpendicular to the direction of rolling:
thickness ≥ 3 mm: A ≥ 20 %,
thickness < 3 mm: A
80 mm
≥ 15 %,
— the average failure energy KCV for three longitudinal test pieces at
minimum working temperature must not be less than 35 J/cm 2 . Not
more than one of the three figures may be less than 35 J/cm 2, with a
minimum of 25 J/cm 2.
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In the case of steels used in the manufacture of vessels the minimum working temperature of which is lower than – 10 °C and the wall thickness of which exceeds 5
mm, this property must be checked.
1.1.2. Aluminium vessels
Non-alloy aluminium must have an aluminium content of at least 99,5 % and the alloys referred to in Article 1(3)(a) must display adequate resistance to intercrystalline
corrosion at maximum working temperature.
Moreover, these materials must satisfy the following requirements:
(a) they must be supplied in an annealed state; and
(b) they must have the following mechanical characteristics per product:
— the maximum tensile strength R
350 N/mm 2 ,
m,max
must be no more than
— the elongation after rupture must be:
— A ≥ 16 % if the test piece is taken parallel to the direction of
rolling,
— A ≥ 14 % if the test piece is taken perpendicular to the direction of rolling.
1.2. Welding materials
The welding materials used to manufacture the welds on or of the simple pressure
vessel must be appropriate to and compatible with the materials to be welded.
1.3. Accessories contributing to the strength of the vessel
These accessories (for example bolts and nuts) must be made of a material specified
in point 1.1 or of other kinds of steel, aluminium or an appropriate aluminium alloy
compatible with materials used for the manufacture of pressurised parts.
The latter materials must at minimum working temperature have an appropriate elongation after rupture and toughness.
1.4. Non-pressurised parts
All unpressurised parts of welded vessels must be of materials which are compatible
with that of the components to which they are welded.
2. VESSEL DESIGN
The manufacturer must, when designing the vessel, define the use to which it will be
put, and select:
(a) the minimum working temperature T
(b) the maximum working temperature T
min
;
max
;
(c) the maximum working pressure PS.
However, should a minimum working temperature exceeding – 10 °C be selected, the
qualities required of the materials must be satisfied at – 10 °C.
74
The manufacturer must also take account of the following provisions:
— it must be possible to inspect the inside of vessels,
— it must be possible to drain the vessels,
— the mechanical qualities must be maintained throughout the period of use of
the vessel for the intended purpose,
— the vessels must, bearing in mind their prescribed use, be adequately protected against corrosion,
and the fact that under the conditions of use envisaged:
— the vessels must not be subjected to stresses likely to impair their safety in
use,
— internal pressure must not permanently exceed the maximum working pressure PS. However, it may momentarily do so by up to 10 %.
Circular and longitudinal seams must be made using full penetration welds or welds of
equivalent effectiveness. Convex ends other than hemispherical ones must have a cylindrical edge.
2.1. Wall thickness
If the product of PS × V is not more than 3 000 bar∙l, the manufacturer must select
one of the methods described in points 2.1.1 and 2.1.2 for determining vessel wall
thickness; if the product of PS × V is more than 3 000 bar∙l, or if the maximum working temperature exceeds 100 °C, such thickness must be determined by the method
described in point 2.1.1.
The actual wall thickness of the cylindrical section and ends shall, however, be not less
than 2 mm in the case of steel vessels and not less than 3 mm in the case of aluminium or aluminium alloy vessels.
2.1.1. Calculation method
The minimum thickness of pressurised parts must be calculated having regard to the
intensity of the stresses and to the following provisions:
(a) the calculation pressure to be taken into account must not be less than the
maximum working pressure PS selected;
(b) the permissible general membrane stress must not exceed the lower of the
values 0,6 R ET or 0,3 R m . The manufacturer must use the R ET and
R m minimum values guaranteed by the material manufacturer in order to determine the permissible stress.
However, where the cylindrical portion of the vessel has one or more longitudinal
welds made using a non-automatic welding process, the thickness calculated as referred to in the first paragraph must be multiplied by the coefficient 1,15.
2.1.2. Experimental method
Wall thickness must be so determined as to enable the vessels to resist at ambient
temperature a pressure equal to at least five times the maximum working pressure,
with a permanent circumferential deformation factor of no more than 1 %.
75
3. MANUFACTURING PROCESSES
Vessels shall be constructed and subjected to production checks in accordance with
the design and manufacturing record referred to in point 3 of Annex II.
3.1. Preparation of the component parts
Preparation of the component parts (for example forming and chamfering) must not
give rise to surface defects or cracks or changes in the mechanical characteristics
likely to be detrimental to the safety of the vessels.
3.2. Welds on pressurised parts
The characteristics of welds and adjacent zones must be similar to those of the welded
materials and must be free of any surface or internal defects detrimental to the safety
of the vessels.
Welds must be performed by qualified welders or operators possessing the appropriate
level of competence, in accordance with approved welding processes. Such approval
and qualification tests must be carried out by approved inspection bodies.
The manufacturer must also, during manufacture, ensure consistent weld quality by
conducting appropriate tests using adequate procedures. These tests must be the subject of a report.
4. PUTTING INTO SERVICE OF THE VESSELS
Vessels must be accompanied by the instructions drawn up by the manufacturer, as
referred to in point 2 of Annex II.
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ANNEX II
‘CE’ MARKING, INSCRIPTIONS, INSTRUCTIONS, DESIGN AND MANUFACTURE
SCHEDULES, DEFINITIONS AND SYMBOLS
1. ‘CE’ MARKING AND INSCRIPTIONS
1.1. ‘CE’ marking
The ‘CE’ marking shall consist of the initials ‘CE’ in the following form:
If the ‘CE’ marking is reduced or enlarged the proportions given in the graduated
drawing set out in this point must be respected.
The various components of the ‘CE’ marking must have substantially the same vertical
dimension, which may not be less than 5 mm.
1.2. Inscriptions
The vessel or data plate must bear at least the following information:
(a) the maximum working pressure (PS in bar);
(b) the maximum working temperature (T
(c) the minimum working temperature (T
max
min
in °C);
in °C);
(d) the capacity of the vessel (V in l);
(e) the name or mark of the manufacturer;
(f) the type and serial or batch identification of the vessel;
(g) the last two digits of the year in which the ‘CE’ marking was affixed.
Where the data plate is used, it must be so designed that it cannot be reused and
must include a vacant space to enable other information to be provided.
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2. INSTRUCTIONS
The instructions must contain the following information:
(a) the particulars given in point 1 except for the vessel’s serial identification;
(b) the intended use of the vessel;
(c) the maintenance and installation requirements for vessel safety.
They must be in the official language or languages of the country of destination.
3. DESIGN AND MANUFACTURING SCHEDULES
The design and manufacturing schedules must contain a description of the techniques
and operations employed in order to meet the essential safety requirements set out in
Annex I or the harmonised standards referred to in Article 5(1), and in particular:
(a) a detailed manufacturing drawing of the vessel type;
(b) the instructions;
(c) a document describing:
— the materials selected,
— the welding processes selected,
— the checks selected,
— any pertinent details as to the vessel design.
When the procedures laid down in Articles 11 to 14 are applied, the schedule must
also include:
(a) the certificates relating to the suitable qualification of the welding operations and of the welders or operators;
(b) the inspection slip for the materials used in the manufacture of parts and
assemblies contributing to the strength of the pressure vessel;
(c) a report on the examinations and tests performed or a description of the
proposed checks.
4. DEFINITIONS AND SYMBOLS
4.1. Definitions
(a) The design pressure ‘P’ is the gauge pressure chosen by the manufacturer and
used to determine the thickness of the vessel’s pressurised parts.
(b) The maximum working pressure ‘PS’ is the maximum gauge pressure which may
be exerted under normal conditions of use of the vessel.
(c) The minimum working temperature T min is the lowest stabilised temperature which
the wall of the vessel may attain under normal conditions of use.
(d) The maximum working temperature T max is the highest stabilised temperature
which the wall of the vessel may attain under normal conditions of use.
78
(e) The yield strength ‘R
of:
ET
’ is the value at the maximum working temperature T
— the upper yield point R
yield point,
eH
max
, for a material with both a lower and an upper
— the proof stress R
p
0,2, or
— the proof stress R
p
1,0 in the case of non-alloy aluminium.
(f) Families of vessels:
Vessels form part of the same family if they differ from the prototype only in diameter,
provided that the permissible requirements referred to in points 2.1.1 and 2.1.2 of
Annex I are complied with, and/or in the length of their cylindrical portion within the
following limits:
— where a prototype has one or more shell rings in addition to the ends, variants must have at least one shell ring,
— where a prototype has just two dished ends, variants must have no shell
rings.
Variations in length causing the apertures and/or penetrations to be modified must be
shown in the drawing for each variant.
(g) A batch of vessels consists at the most of 3 000 vessels of the model of the same
type.
(h) There is series manufacture within the meaning of this Directive if more than one
vessel of the same type is manufactured during a given period by a continuous manufacturing process, in accordance with a common design and using the same manufacturing processes.
(i) Inspection slip: document by which the producer certifies that the products delivered meet the requirements of the order and in which he sets out the results of the
routine in-plant inspection test, in particular chemical composition and mechanical
characteristics performed on products made by the same production process as the
supply, but not necessarily on the products delivered.
4.2. Symbols
A
A 80 mm
KCV
P
PS
Ph
RP 0,2
RET
ReH
Rm
Rm,max
Rp1,0
Tmax
Tmin
V
elongation after rupture Lo = 5,65So
elongation after rupture (Lo = 80 mm)
rupture energy
design pressure
maximum working pressure
hydrostatic or pneumatic test pressure
proof stress at 0,2 %
yield strength at maximum working temperature
upper yield point
tensile strength
maximum tensile strength
proof stress at 1 %
maximum working temperature
minimum working temperature
capacity of the vessel
79
%
%
J/cm2
Bar
Bar
Bar
N/mm²
N/mm²
N/mm²
N/mm²
N/mm²
N/mm²
°C
°C
l
ANNEX III
MINIMUM CRITERIA TO BE MET BY MEMBER STATES FOR THE APPROVAL OF
INSPECTION BODIES
(referred to in Article 9(2))
1. The approved inspection body, its director and the staff responsible for carrying out
the verification tests shall not be the designer, manufacturer, supplier or installer of
vessels which they inspect, nor the authorised representative of any of those parties.
They shall not become directly involved in the design, construction, marketing or
maintenance of the vessels, nor represent the parties engaged in those activities. This
does not preclude the possibility of exchanges of technical information between the
manufacturer and the approved inspection body.
2. The approved inspection body and its staff must carry out the verification tests with
the highest degree of professional integrity and technical competence and must be
free from all pressures and inducements, particularly financial, which might influence
their judgment or the results of the inspection, especially from persons or groups of
persons with an interest in the result of verifications.
3. The approved inspection body must have at its disposal the necessary staff and the
necessary facilities to enable it to perform properly the administrative and technical
tasks connected with verification; it must also have access to the equipment required
for special verification.
4. The staff responsible for inspection must have:
(a) sound technical and professional training;
(b) satisfactory knowledge of the requirements of the tests they carry out and
adequate experience of such tests;
(c) the ability to draw up the certificates, records and reports required to authenticate the performance of the tests.
5. The impartiality of inspection staff must be guaranteed. Their remuneration must
not depend on the number of tests carried out or on the results of such tests.
6. The approved inspection body must take out liability insurance unless its liability is
assumed by the State in accordance with national law, or the Member State itself is
directly responsible for the tests.
7. The staff of the approved inspection body is bound to observe professional secrecy
with regard to all information gained in carrying out its tasks (except vis-à-vis the
competent administrative authorities of the State in which its activities are carried out)
under this Directive or any provision of national law giving effect to it.
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ANNEX IV
PART A
Repealed Directive with list of its successive amendments
(referred to in Article 19)
Council Directive 87/404/EEC (OJ L 220, 8.8.1987, p. 48)
Council Directive 90/488/EEC (OJ L 270, 2.10.1990, p. 25)
Council Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1)
Article 1, point 1, and Article 2 only
PART B
List of time limits for transposition into national law and application
(referred to in Article 19)
Directive
Time limit for transposition
Date of application
1
87/404/EEC
31 December 1989
1 July 1990 (
)
90/488/EEC
1 July 1991
-
93/68/EEC
30 June 1994
1 January 1995 (
2
)
1
( ) In accordance with the third subparagraph of Article 18(2), Member States shall, for the period up to
1 July 1992, permit the placing on the market and/or in service of vessels conforming to the rules in force
in their territories before 1 July 1990.
2
( ) In accordance with Article 14(2), until 1 January 1997 Member States shall allow the placing on the
market and the bringing into service of products which comply with the marking arrangements in force
before 1 January 1995.
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ANNEX V
CORRELATION TABLE
Directive 87/404/EEC | This Directive |
Recital 5, fifth sentence | Article 1(3), point (b) |
Article 1(1) | Article 1(1) |
Article 1(2), first subparagraph | Article 1(3), point (a), first subparagraph |
.............
.............
.............
Annex III, point 4, first, second and third indents | Annex III, point 4, points (a), (b) and (c) |
Annex III, points 5, 6 and 7 | Annex III, points 5, 6 and 7 |
— | Annex IV |
— | Annex V |
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