EU legislation on CE-marking: Pressure Equipment

- Implementation plan -
Introduction
CE marking your product in many cases is not an easy thing to do. Therefore, CBI developed
this document that will guide you through the whole process of CE marking pressure
equipment. This guidance is based on the experiences of CBI when assisting exporters in
developing countries.

 For more information see the related documents:

• CE marking Introduction, explaining the basics and used terminology.
• CE marking implementation plan, describing the step-by-step approach used in this
document as well.

This document outlines the specific issues for Directive 97/23/EC: Pressure Equipment
(PED). So, if you are manufacturing or exporting pressure equipment to the EU, please
read this document carefully.

In this document, a number of links have been included, either by text in blue (before the
first use of this link), in purple (after the first use of this link) or by showing an arrow “>” –
symbol or underlined text. Depending on the settings of your computer, you may get access
to the links by one of the following modes:
- Clicking,
- Double clicking
- Pressing [Ctrl] and clicking simultaneously with the mouse (left mouse click)
- Right mouse click, select “open hyperlink”, left mouse click.

If the links do not work, please contact CBI.

Steps to apply the CE-marking

Step 1 Determine which Directive(s) are applicable to your product

Step 2 Check which standard(s) are applicable to your product
Step 3 Check if the product complies with the essential health and safety
requirements of the Directive
Step 4 Check if a notified body must be involved for certification; contact the
notified body for details on the procedures
Step 5 Draw up a Technical File, showing how the product complies with the
requirements of the Directives, and which specifications (standards) have
been applied
Step 6 Test the product (type) according to the specifications in the technical file,
and, if required in the relevant Directive(s), submit a model of the product
to an EC type approval by a notified body, and, if required, submit the
production process to a quality control procedure as described in the
Directive.*
Step 7 Draw up an EC Declaration of Conformity and affix the CE marking to
the product.*

* Note that this step-by-step approach is slightly different from the step model in
other Directives, as described in different documents. The reason is the importance of the
production process in the conformity assessment, which makes it easier to use the steps as
described above.

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Step 1 - Determine which Directive(s) are applicable to your product

Find out which Directive applies to your product. This is done by looking at the scope of the
Directive, which is described in its text. Please note that more than one Directive might be
applicable to your product.

1.1 The Pressure Equipment Directive

Directive 97/23/EC applies to pressure equipment and also called the PED. Step 1 requires
investigation whether other Directives might be applicable as well. The scope of the Directives
reveals if a product is described by the Directive. Some products may be subject to more than
one Directive. For example, if the pressure equipment, covered by the Pressure Equipment
Directive contains electrical apparatus, the Directive Electro-Magnetic Compatibility (EMC) is
also applicable. For diving apparatus, the Personal Protective Equipment Directive (PPE) is
relevant alongside with the requirements of the PED. See the related documents on the various
Directives mentioned here. To establish the relevance of the other Directives, see step 1 in
each of the Directives described.

Directives that possibly apply as well

Directive Title Abbreviation
89/336/EEC (as amended) Electromagnetic Compatibility EMC
2004/108/EC (from 2007)
89/686/EEC (as amended) Personal Protective Equipment PPE

Please note that each definition is known for its exceptions. Thus, the simultaneous application
in two different Directives may also be excluded. The simultaneous use of a number Directives
is excluded. For example, simple pressure vessels are covered by the Simple Pressure Vessel
Directive (SPVD), not by the PED. Neither is the Machinery Directive (MD) applicable, nor the
Low Voltage Directive (LVD), nor the ATEX Directive. These exclusions are listed in Directive
97/23/EC (PED), article 1 (3).

Directive Title Abbreviation

98/37/EC Machinery MD
73/23/EEC (as amended) Low Voltage LVD
87/404/EEC (as amended) Simple Pressure Vessels SPVD
94/9/EC Equipment and protective systems ATEX
intended for use in potentially explosive
atmospheres

Please note that machinery may be linked to pressure equipment, where the assembly must
comply with the Machinery Directive. See the document on the Machinery Directive.

 Please note, that a full list of Directives is shown in the related document CE marking
implementation plan. This includes a table with arrows, which are links to websites showing
Directives, information about Directives, development of standards, and a list of harmonised
standards in relation to the Directive concerned.

The full text of the Pressure Equipment Directive may be accessed here. An explanation of the
various articles and annexes of the Directive may be seen by clicking on the links listed in the
Index (scroll dwon the page).

1.2 Scope and definitions of the Pressure Equipment Directive

The PED Directive applies to the design, manufacture, and conformity assessment of pressure
equipment and assemblies of pressure equipment with maximum allowable pressure greater
than 0.5 bar above atmospheric pressure (i.e. 1,5 bar of absolute pressure). For the full scope,
please use the following link Article 1 of the Directive.

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For definitions, you can consult the same article 1 as mentioned above. The following
definitions are import to take notice of:

Pressure equipment includes vessels, piping, safety accessories and pressure accessories.
Where applicable, pressure equipment includes elements attached to pressurised parts, such
as flanges, nozzles, couplings, supports, lifting lugs etc.

Vessels are defined as a housing designed and built to contain fluids under pressure.

Piping means piping components intended for the transport of fluids, when connected together
for integration into a pressure system.

Safety accessories means devices designed to protect pressure equipment against the
allowable limits being exceeded.

Pressure accessories means devices with an operational function and having pressure bearing
housings.

Assemblies mean several pieces of pressure equipment assembled by a manufacturer to

constitute an integrated and functional whole.

1.3 Exclusions from the scope of the PED

In a number of cases pressure equipment - although designed for a maximum allowable
pressure above the limit - is excluded, for example:
• Equipment which is already regulated at EU level;
• Equipment presenting a minor pressure hazard (category I of the PED) and which is
covered by Directives on machinery, lifts, low voltage, medical devices, gas appliances and
on explosive atmospheres;
• Equipment which does not present any significant pressure hazard, such as for distribution
of water, radiators and piping for hot water heating systems, carbonated drink containers;
• Equipment which presents a significant pressure hazard but for which neither the free
circulation aspect nor the safety aspect necessitated its inclusion, e.g. high voltage switch
gear

 See also Article 1 (3) of the Directive (scroll down the page).

Step 2 - Check which standard(s) are applicable to your product

For compliance with the Directives that apply to your product, standards give detailed
technical information on implementing the EU requirements. However, not all standards have
been harmonised yet. Only standards that have their reference published in the Official
Journal of the EU are called ‘harmonised standards’. Complying with these standards means
that the authorities presume compliance with the Directives. This step of checking the
relevant standards – whether or not harmonised – is crucial for CE-marking.

2.1 How to find harmonised standards

Standards give detailed technical information on implementing the EU requirements. It is up to
the manufacturer to choose how to implement the requirements, since the New Approach
Directives are based on a voluntary use of standards for filling in the technical details.

The information contained in the summarized list - list of harmonised standards for PED - is a
compilation of the references of standards that have been published in the Official Journal of
the European Union. Although this list is updated regularly, it may not be complete. Therefore,
check the link given above regularly.

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2.2 Other standards and draft standards
Many more standards are under development. At the website of CEN you can look up
standards and their status (e.g. ratified, under approval). First you have to select your
Directive area (pressure equipment), next specific criteria, then the website will generate all
standards.

Many more standards are under development. A list of standardization activities for various
types of pressure equipment is given in Annex B of this document. Click ( EU standards).

Step 3 - Check if the product complies with the essential health and safety
requirements of the Directive
Apply the relevant standards for the performance requirements in the Directives or the
technical verification, and, where appropriate, a risk assessment.

The EU designed flow charts for all Directives with the process of the so-called “conformity
assessment”. You can find the flow chart for pressure equipment in Annex A of this document.
Click ( Flow Chart). It is recommended to print this flow chart.

3.1 Product Classification

In order to determine how the Directive will apply to specific items of pressure equipment, a
manufacturer classifies the equipment into one of four conformity assessment categories: or
Categories I to IV. Category I relates to the lowest, category IV to the highest hazard category.
(See also Article 3 of the Directive.)

Equipment below Category I come under so-called sound engineering practice or SEP, and is
not subject to conformity assessment and CE marking.

In order to determine which category an item of equipment falls into the manufacturer needs
to identify:
• The type of equipment – vessel / steam generators / piping
• The state of the intended fluid contents - gaseous or liquid
• The fluid group of the intended contents – group 1 or group 2

Group 1 comprises those fluids classified according to the EC Directive on the classification of
dangerous substances as:
• explosive
• extremely flammable
• highly flammable
• flammable (where the maximum allowable temperature is above flashpoint)
• very toxic
• toxic
• oxidising

Group 2 comprises all other fluids including water/steam.

Depending on how you classify your product, i.e. following the above description, the Directive
gives nine tables in Annex II which you should use to determine the applicable conformity
assessment category, i.e. (SEP (sound engineering practice), I, II, III or IV).

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Table 1. Product Classifications and relevant tables
Vessels Steam Piping
Generators
State of Gas Liquid Gas Liquid
Contents
Fluid D O D O D O D O
Group

D= Dangerous
O= Other
Refer to 1 2 3 4 5 6 7 8 9
Table/Graph
(Annex II of PED)

Explanation: On each of these graphs (1-9) maximum allowable pressure (PS) (bar) is plotted
against, for vessels, the volume in litres, V (L), and for piping, the nominal size (DN). These
tables have up to five bands relating to the different categories (SEP, I, II, III or IV).
Demarcation lines on each table indicate the upper limit of maximum allowable pressure and
volume or nominal size for each category. The manufacturer has to plot the maximum
allowable pressure and volume or nominal size for their piece of equipment on the relevant
chart to identify which category the item of equipment falls into. In general, the lower the
pressure and volume, the lower the category for the equipment.

Pressure accessories: Tables 1 to 4 for vessels or tables 6 to 9 for piping in Annex II are
applicable depending on whether the volume V or the nominal size DN is considered
appropriate for classification of the pressure accessory. Where both the volume and the
nominal size are considered appropriate, the pressure accessory must be classified in the
highest category.

Safety accessories: These are generally classified under category IV. Safety accessories
manufactured for specific equipment may be classified in the same category as the equipment
they protect.

Assemblies: Specific provisions (article 10.2) are applicable which are based on the
classification of the individual parts of pressure equipment of which the assembly is composed.

3.2 Technical Requirements

The Directive requires that all pressure equipment and assemblies within its scope must be
safe when placed on the market and put into service. For equipment falling under sound
engineering practice (SEP) the essential requirements, the certification procedures and the CE
marking are not applicable.

Pressure Equipment under categories I, II, III and IV must meet the essential requirements
given in Annex I of the Directive. Assemblies which include at least one item of pressure
equipment classified in Categories I to IV will also be required to meet the essential safety
requirements. These include extensive requirements for design, manufacturing, testing,
marking and labelling and materials.

The manufacturer is obliged to analyse the hazards in order to identify those that apply to his
equipment. He must design, manufacture and check his equipment to ensure its safety with
respect to their use under reasonably foreseeable conditions. In addition, the manufacturer
must interpret and apply the essential requirements in such a way as to take account of the
state-of-the-art at the time of design. That latter requirement highlights the evolutive
character of the essential requirements that is inherent in the new approach.

With respect to materials the manufacturer of pressure equipment must adhere to the
essential safety requirements by using appropriate materials:

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• which comply with harmonised standards
• which are covered by European Approval of Materials in accordance with (Article 11)
• which are evaluated by a particular material appraisal.

 For more information on technical requirements, see Article 3 of the Directive.

Step 4 - Check if a notified body must be involved for certification

Contact the notified body for details on the procedures.

It depends on the Directive(s) involved if a notified body must be involved for certification of
the product and the production process. This is required for pressure equipment, see step 6.
For a list of notified bodies specifically for the PED, click here.

 Please note that 10 practical tips on how to select a notified body are given in the related
document explaining the step by step approach followed in this document, i.e. the document
CE marking implementation plan.

Step 5 - Draw up a Technical File, showing how the product complies with the
requirements of the Directives, and which specifications (standards) have been
applied
The technical file contains the documentation on how the conformity has been achieved.

The following points have to be taken into account:

European Approval of Materials Article 11 is a technical document defining the

characteristics of materials intended for repeated use in the manufacture of pressure
equipment the type of which is not already covered by a harmonised standard. Notified bodies
issue these documents. The notified body shall determine and perform the appropriate
inspections and tests to certify the conformity of the types of material with the corresponding
requirements of the PED.

Special Requirements are given in addition to the applicable requirements of Sections 1 to 4

(General, Design, Manufacturing and Materials) of Annex I for 'Fired or otherwise heated
pressure with a risk of overheating’ in Section 5 and Section 6.

Specific quantitative requirements for certain pressure equipment materials are given as
general rules in Section 7 of Annex I. The provisions laid down in this section supplement the
essential requirements of Sections 1 to 6 for the pressure equipment to which they apply.
These give allowable stresses, joint coefficients, hydrostatic test pressures and material
characteristics. Values not to be exceeded for the permissible general membrane stress for
predominantly static loads and for temperatures outside the range in which creep is significant
are given for ferritic steel, austenitic steel, non alloy or low alloy cast steel, aluminium and
aluminium alloys. Coefficients are given for welded joints.

Permanent joining of components which contribute to the pressure resistance of the

equipment and components which are directly attached to them must be carried out by
suitably qualified personnel according to suitable operating procedures. For pressure
equipment in categories II, II and IV operating procedures and personnel must be approved by
a competent third party which at the manufacturers discretion, may be a notified body or a
third party organisation recognised by a EU member state. To carry out these approvals the
third party must perform examinations and tests as set out in the appropriate harmonised
standards or equivalent examinations or tests.

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Step 6 – Test the product (type) according to the specifications in the technical file,
and, if required in the relevant Directive(s), submit a model of the product to an EC
type approval by a notified body
All testing carried out by the manufacturer, a laboratory, test house or notified body, will be
included in the technical file. Since it is not always possible or feasible to test onsite, the
technical file may be completed as far as the description of the product and the (intended)
compliance with the relevant Directives and standards.

The submission of the product to the EC-type approval is the procedure that the product
(prototype) is tested and certified. A type of the product, or a range if various types are
tested at the same time. is sent to a notified body.

6.1 Conformity Assessment

Before putting pressure equipment related to categories I to IV on the market, the equipment
has to be subject to the appropriate conformity assessment procedures (modules). According
to the category of the equipment, manufacturers will be given a choice of the ‘modules’ shown
in tables 2 and 3 (see below).

Manufacturers may chose either a procedure based on:

• product control or
• a procedure based on quality systems
Furthermore, the modules attributed to a higher hazard category may be used in lower
categories.

For conformity assessment of assemblies the provisions of article 10.2 apply. This requires,
that an item of pressure equipment which is part of an assembly, is assessed according to the
tables in Annex II and an assessment is carried out on the integration of each item.

The modules for products in Categories II, III and IV require the involvement of notified bodies
(Article 12), which are appointed by EU member states, either in the approval and monitoring
of the manufacturers’ quality system or in direct product inspection. Recognised third-party
organisations (Article 13) may also be appointed by EU member states to carry out the
approval of welding procedures and personnel and non-destructive testing personnel as
required for pressure equipment assemblies in Categories II, III and IV.
User inspectorates (Article 14) may also be appointed by EU member states to carry out the
tasks of notified bodies within their own organisations under Modules A1, C1, F and G only. The
CE marking is not affixed to pressure equipment and assemblies assessed by user
inspectorates.

Table 2. Modules for each category

Safety Hazard Conformity Assessment
Category Modules
I A
II A1
D1
E1
III B1 + D
B1 + F
B+E
B +C1
H
IV B+D
B+F
G
H1

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Table 3. Conformity Assessment Procedure for each module
Module Conformity Assessment
Procedure
A Internal production control
A1 Internal production control with
monitoring of final assessment
B EC type – examination
B1 EC design – examination
C1 Monitoring of final assessment
D Quality assurance for production,
final inspection and testing
D1 Quality assurance for production,
final inspection and testing
E Quality assurance for final
inspection and testing
E1 Quality assurance for final
inspection and testing
F Product verification
G Unit verification
H Full quality assurance
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Description
This module describes the procedure by which
manufacturer ensures and declares that pressure
equipment satisfies the requirements of the
Directive which apply to it.
As above but in addition includes monitoring of
final assessment by notified body.
Describes the part of the procedure where a
notified body ascertains and attests that a
representative example of the production meets
the provisions of the Directive which apply to it.
Describes the part of the procedure where a
notified body ascertains and attests that the design
of an item meets the provisions of the Directive
which apply to it
Describes procedures where the manufacturer, or
authorised representative ensures and declares
that the pressure equipment is in conformity with
the type as described in the EC type examination
certificate and satisfies the requirements of the
Directive which apply to it.
Describes procedures where the manufacturer
ensures and declares that the pressure equipment
conforms with the type described in the EC type
examination certificate or the EC design certificate
and satisfies the requirements of the Directive
which apply to it.
This module describes the procedure by which
manufacturer ensures and declares that pressure
equipment satisfies the requirements of the
Directive which apply to it.
Describes procedures where the manufacturer
ensures and declares that the equipment is in
conformity with the type described in the EC type
examination certificate and satisfies the
requirements of the Directives that apply to it.
Describes the procedure where the manufacturer
ensures and declares that the equipment satisfies
the requirements of the Directive that apply to it.
Describes the procedure where the manufacturer
or authorised representative ensures and declares
the pressure equipment is in conformity with the
type as described in the EC type examination
certificate or the EC design certificate and satisfies
the requirements of the Directive.
Describes the procedure where the manufacture
ensures and declares the pressure equipment that
has been issued with a certificate of conformity for
tests carried out satisfies the requirements of the
Directive.
Describes the procedure where the manufacture
ensures and declares the pressure equipment
satisfies the requirements of the Directive.
H1 Full quality assurance with As above.
design examination and
monitoring of final assessment

6.2 Production control

Many of the conformity assessment procedures referred to above (6.1). This is to ensure that
the quality remains the same and that there are no deviations from the approved type.

The EC declaration of conformity becomes void if alterations to the type are made.
Some alterations may be very small. Still, it is important to put these alterations into a file and
to submit this to the notified body before affixing the CE marking.

New and revised standards do not influence the validity of the CE marking and the
EC Declaration of Conformity.

Step 6 – Draw up an EC Declaration of Conformity and affix the CE marking

With the EC Declaration of Conformity, the manufacturer officially declares that the product
complies with essential requirement of the applicable Directives. The manufacturer also
declares that, if this product has been submitted to an EC type approval, each product is in
conformity with the model that has been approved.

Once conformity assessment has been completed, and if the equipment or assembly complies
with the provision of the Directive, the manufacturer will be required to affix the CE-marking to
each item of pressure equipment or assembly and draw up a declaration of conformity.

The CE conformity marking shall consist of the initials ‘CE' taking the following form:

• If the CE marking is reduced or enlarged the proportions given in the above graduated
drawing 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.

 Please see the Directive for:

• Declaration of conformity Annex VII
• CE-marking Annex VI

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Annex A Conformity assessment Click ( back to the text)

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Annex B: EU standards and draft standards Click ( back to the text)

 For an explanation on how to use the table after clicking the arrows below, please see the
document on the outline of the CE marking implementation plan.

Directive 97/23/EC - Pressure equipment View

Standards
(Click “>” to
find the
relevant
internet sites
Aluminium and aluminium alloys >
Automatic controls for household use >
Copper and copper alloys >
Cryogenic vessels >
Flanges and their joints >
Flat products for cold working >
GRP tanks and vessels >
Industrial piping and pipelines >
Industrial valves >
Liquefied petroleum gas equipment and accessories >
Manual means of fire fighting equipment >
Non-destructive testing >
Plastics piping systems and ducting systems >
Refrigerating systems, safety and environmental requirements >
Safety of household and similar electrical appliances >
Shell and water tube boilers >
Shop fabricated metallic tanks & equipment for storage and for service >
stations
Steel castings >
Steel forgings >
Steel tubes and fittings for steel tubes >
Steels for heat treatment, alloy steels and free-cutting steels >
Steels for pressure purposes - Qualities >
Structural steels - Grades and qualities >
Technical conditions of delivery and quality control >
Threaded and non-threaded mechanical fasteners and accessories >
Transportable gas cylinders >
Unfired pressure vessels >
Utensils in contact with food >
Welding >
Wire-rod - Qualities, dimensions, tolerances and specific tests >

Last update: January 2006

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