EU legislation on CE-marking: Pressure Equipment - Instruction plan Summary This file will guide you through the whole

process of CE marking for pressure equipment. This guidance is based on the experiences of CBI when assisting exporters in developing countries. So, if you are manufacturing or exporting pressure equipment to the EU, please read this document carefully. This document outlines the specific issues for Directive 97/23/EC: Pressure Equipment (PED). The sector and the product range covered by pressure equipment directives is enormous: from kitchen pressure cookers to boilers in electrical power stations, including also complete chemical plants. In the same area, we cover simple pressure vessels and aerosols. "Pressure" is a traditional sector, which started to be regulated right from the industrial revolution. Community law based on the New Approach not only does open up markets between Member States, but it also promotes innovation, increasing the competitiveness of industry. This directive has not been changed recently. The information has undergone editorial changes only. Steps to apply the CE-marking

Step 1 Step 2 Step 3 Step 4 Step 5 Step 6

Step 7

Determine which Directive(s) are applicable to your product Check which standard(s) are applicable to your product Check if the product complies with the essential health and safety requirements of the Directive Check if a notified body must be involved for certification; contact the notified body for details on the procedures Draw up a Technical File, showing how the product complies with the requirements of the Directives, and which specifications (standards) have been applied 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.* 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. Click here for the full text Directive 97/23/EC. An explanation of the various articles and annexes of the Directive may be seen by clicking on the links listed in the Index (scroll down the page). 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 2004/108/EC 89/686/EEC (as amended) Title Electromagnetic Compatibility Personal Protective Equipment Abbreviation EMC 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 98/37/EC 2006/95/EC (as amended) 87/404/EEC (as amended) 94/9/EC Title Machinery Low Voltage Simple Pressure Vessels Equipment and protective systems intended for use in potentially explosive atmospheres Abbreviation MD LVD SPVD ATEX

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. 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). The Directive concerns manufacturers of items such as vessels pressurised storage containers, heat
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exchangers, steam generators, boilers, industrial piping, safety devices and pressure accessories. Such pressure equipment is widely used in the process industries (oil & gas, chemical, pharmaceutical, plastics and rubber and the food and beverage industry), high temperature process industry (glass, paper and board), energy production and in the supply of utilities, heating, air conditioning and gas storage and transportation. For the full scope, please use the following link Article 1 of the Directive. For definitions, you can consult the same article 1 as mentioned above. The following definitions are important 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. TERM USED

Essential safety requirements (ESRs) (Annex I) lay down the necessary safety elements for protecting public interest. Essential safety requirements for design, manufacture, testing, marking, labelling, instructions and materials, usually written in general terms, are mandatory and must be met before products may be placed on the market in the European Community. Conformity Assessment (Article 10) must be undertaken by the manufacturer or notified body, depending on the category of the equipment, in order to demonstrate that the essential safety requirements are met. Conformity Assessment Modules (Annex III) The New Approach has introduced a modular approach to conformity assessment, thereby subdividing it into a number of independent activities. Modules differ according to the type of assessment (e.g. documentary checks, type approval, design approval, quality assurance) and the organisation carrying out the assessment (i.e. the manufacturer or a third party). Sound Engineering Practice (Article 3.3) applies to equipment that is not subject to conformity assessment but must be designed and manufactured in accordance with the sound engineering practice of a Member State in order to ensure safe use. That equipment must ensure that design and manufacture takes into account all relevant factors influencing safety during the intended lifetime. The equipment must be accompanied with adequate instructions for use and must bear the identification of the manufacturer. The responsibility for compliance with the PED lies solely with the manufacturer. Notified Body (Article 12) is a semi-official or private technical organisation appointed by Member States, either for approval and monitoring of the manufacturers' quality assurance system or for direct product inspection. A Notified Body may be specialised for certain products, product categories or for certain modules. Recognised Third Party Organisations (Article 13) are appointed by Member States to carry out the approval of welding procedures and personnel and non-destructive testing personnel User Inspectorates (Article 14) are appointed by Member States to carry out the tasks of notified bodies within their own companies under Modules A1, C1, F and G only. (The CE
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marking should not be affixed to pressure equipment and assemblies assessed by user inspectorates). CE Marking (Article 15) declares the completion of conformity assessment and that the equipment or assembly complies with the provisions of the Directive and meets the essential safety requirements. Published Harmonised (European) Standards (Article 5.2), list are a specific subset of European Standards (EN, produced by CEN and available from the national Standards Institutes) with particular consideration of the Essential Safety Requirements the reference number of which is published in the Official Journal of the European Commission. The use of a Published Harmonised Standard in the design and manufacture of a product will give the presumption of conformity (Article 5.1) to those ESRs listed in Annex ZA of the particular Harmonized Standard. 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 harmonized standards. Complying with these standards means that the authorities presume compliance with the Directives. This step of checking the relevant standards whether or not harmonized is crucial for CE-marking. 2.1 How to find harmonized 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 harmonized 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. 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).

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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 (SEP). This 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 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, I, II, III or IV). Table 1. Product Classifications and relevant tables Vessels State of Contents Fluid Group D= Dangerous O= Other Refer to Table/Graph (Annex II of PED) Gas D O Liquid D O Steam Generators Piping Gas D O Liquid D O

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).
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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. SEP ensures that equipment design and manufacture takes into account all relevant factors influencing safety during the intended lifetime. The equipment must be accompanied with adequate instructions for use and must bear the identification of the manufacturer. 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: 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.

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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 issues need 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 ferrite 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. 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) must be tested and certified. A type of the product, or a range if various types are tested at the same time.
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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 (Article14) 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 Category I II III Conformity Assessment Modules A A1 D1 E1 B1 + D B1 + F B+E B +C1 H B+D B+F G H1

IV

Table 3. Conformity Assessment Procedure for each module Module A Conformity Assessment Procedure Internal production control 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. This module describes the part of the procedure where a notified body ascertains and attests that a

A1 B

Internal production control with monitoring of final assessment EC type examination

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B1

EC design examination

C1

Monitoring of final assessment

Quality assurance for production, final inspection and testing

D1

Quality assurance for production, final inspection and testing

Quality assurance for final inspection and testing

E1

Quality assurance for final inspection and testing Product verification

Unit verification

Full quality assurance

H1

Full quality assurance with design examination and monitoring of final assessment Production control

representative example of the production meets the provisions of the Directive which apply to it. This module 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 This module 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. This module 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. This module 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. This module describes the procedure where the manufacturer ensures and declares that the equipment satisfies the requirements of the Directive that apply to it. This module 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. This module 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. This module describes the procedure where the manufacture ensures and declares the pressure equipment satisfies the requirements of the Directive. As above.

6.2

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.

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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 7 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 Last updated: June 2009

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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 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 View Standards

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