Eu Ce Simple Pressure

EU legislation on CE-marking: Simple Pressure Vessels - 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 simple pressure vessels. 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 87/404/EEC:Simple Pressure Vessels. So, if you are manufacturing or exporting simple pressure vessels 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 Step 2 Step 1 Step 3 Step 2 Step 3 Step 4 Step 4 Step 5 Step 5 Step 6 Step 6 Step 7 Step 7 Step 8 Step 8 Step 9 Step 10

Determine which Directive(s) are applicable to your product Check which standard(s) are applicable to your product Determine which Directive(s) are applicable to your product Check if the product complies with the essential health and safety requirements Check which standard(s) are applicable to your product of the Directive(s) Check if the product complies with the essential health and safety Check if a notified body must be involved for certification, contact the notified requirements of the Directive body for details on the procedures Draw up a Technical File, showing how the product complies with the Draw up a Technical File, showing how the product complies with the requirements of the Directives, and which specifications (standards) have requirements of the Directives, and which specifications (standards) have been been applied applied Test the product (type) according to the specifications in the technical file, Test the product (type) according to the specifications in the technical file, and, and, if required in the relevant Directive(s), submit a model of the product to if required in the relevant Directive(s), submit a model of the product to an EC an EC type approval by a notified body type approval by a notified body Draw up an EC Declaration of Conformity Draw up an EC Declaration of Conformity Draw up a file in which the production process is described Draw up a file in which the production process is described and, if required in the relevant Directive(s), submit the production process to and, if required in the relevant Directive(s), submit the production process to a a quality control procedure as described in the Directive(s) quality control procedure as describes in the Directive(s) After all conformity assessment procedures, affix the CE-Marking to the After all conformity assessment procedures: affix the CE-marking to the product product Monitor the production process

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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 Simple Pressure Vessels Directive

The text of Directive 87/404/EEC: Simple Pressure Vessels can be read from the EU website at Simple Pressure Vessels. In order to clarify the requirements form the Directive, you will find some tables and graphics in this document. Moreover, you can find a guidance document (in PDF) at the following link: Guide on Simple Pressure Vessels. Please note that step 1 requires investigation whether other Directives might be applicable as well or whether the simultaneous application in two different Directives may be excluded. Pressure vessels excluded from this Directive may be subject to the Pressure Equipment Directive (PED). Pressure vessels that are part of Machinery, may be subject to the Machinery Directive (MD) and other related Directives. See the separate documents on the various Directives mentioned here. Directives that possibly apply as well Directive 97/23/EC (as amended) 98/37/EC

Title Pressure Equipment Machinery

Abbreviation PED MD

 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

Applicability

This Directive applies to simple pressure vessels manufactured in series. This 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. Moreover, the following points are important: • 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: o either a cylindrical part of circular cross-section closed by outwardly dished and/or flat ends which revolve around the same axis as the cylindrical part, o or 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.V) shall not exceed 10000 bar/litre, • The minimum working temperature must not be lower than minus 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. Please note: The abovementioned criteria are given to establish if this Directive is applicable. These are not requirements the simple pressure vessels shall meet (Step 3). 1.3

Exclusions from the scope of the Directive

•

The following vessels shall be excluded from the scope of the Directive: Vessels that are not covered by the criteria in item 1.2 “Applicability”

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•

Vessels specifically designed for nuclear use, failure of which may cause an emission of radioactivity, Vessels specifically intended for installation in or the propulsion of ships and aircraft, Fire extinguishers.

• •

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 EU is in the process of harmonising the standards that are used in all the individual EU countries. A list of harmonized standards can be found: Harmonized standards for simple pressure vessels If the pressure vessels entirely comply with the harmonized standards for all aspects involved, there may be a difference in the conformity assessment procedure, see step 5 and step 7. There are various standardization activities in field of simple pressure vessels. They are listed: Directive 87/404/EEC - Simple pressure vessels Aluminium and aluminium alloys Non-destructive testing Threaded and non-threaded mechanical fasteners and accessories Unfired pressure vessels Welding

View Standards > > > > >

This table can be used to see the various Directives. The arrows “>” are links to a list of harmonized standards in relation to the Directive concerned. For further information about the application of the standards, please consult CBI through [email protected].  For an explanation on how to use the table after clicking the arrows, please see the document on the outline of the CE marking implementation plan.  Please note that although the list is updated regularly, it may not be complete. All newly harmonized standards are published in the Official Journal of the EU. 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, next specific criteria, then the website will generate all 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. Source: CBI Market Information Database • URL: www.cbi.nl • Contact: [email protected] • www.cbi.nl/disclaimer Page 3 of 11

Note that the user documentation (installation, operating manual, maintenance instructions, etc.) is an integral part of the product and needs to be assessed together with the product. Vessels in respect of which the product of PS and V exceeds 50 bar/litre must satisfy the essential safety requirements set out in Annex I of the Directive. Vessels in respect of which the product of PS and V is 50 bar/litre or less must be manufactured in accordance with sound engineering practice (S.E.P.) in one of the Member States and bear markings as laid down in section 1 of Annex II, (see step 8), with the exception of the CE marking referred to in Article 16. The essential safety requirements for the vessels are set in Annex 1 of the Directive and are the following: 1. Materials Materials must be selected according to the intended use of the vessels and in accordance with 1.1 to 1.4 of the Directive. 1.1. Pressurized parts The materials referred to in Article 1 used for manufacturing the pressurized parts must be: • capable of being welded, • ductile and tough, so that a rupture at minimum working temperature does not give rise to either fragmentation or brittle-type fracture, • not adversely affected by ageing. For steel vessels, the materials must in addition meet the requirements set out in section 1.1.1 and, for aluminium or aluminium alloy vessels, those set out in section 1.1.2 of the Directive. They must be accompanied by an inspection slip drawn up by the producer of the materials as described in Annex II. 1.1.1. Steel vessels Non-alloy quality steels meet the following requirements: • they must be non-effervescent and be supplied after normalization treatment, or in an equivalent state; • 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 %. • they must have the following mechanical properties per product: o the maximum tensile strength Rm,max must be less than 580 N/mm2, o 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: A80 mm ≥ 17 %,  if test pieces are taken perpendicular to the direction of rolling: thickness ≥ 3 mm: A ≥ 20 %, thickness < 3 mm: A80 mm ≥ 15 %, o the average failure energy KCV for three longitudinal test pieces at minimum working temperature must not be less than 35 J/cm2. Not more than one of the three figures may be less than 35 J/cm2, with a minimum of 25 J/cm2. In the case of steels used in the manufacture of vessels whose minimum working temperature is lower than − 10 ºC and whose all thickness exceeds five mm, this property must be checked. 1.1.2. Aluminium vessels Non-alloy aluminium must have an aluminium content of at least 99,5 % Source: CBI Market Information Database • URL: www.cbi.nl • Contact: [email protected] • www.cbi.nl/disclaimer Page 4 of 11

and those alloys described in Article 1 (2) must display adequate resistance to intercrystalline corrosion at maximum working temperature. Moreover these materials must satisfy the following requirements: • they must be supplied in an annealed state; and • must have the following mechanical characteristics per product: o the maximum tensile strength Rm,max must be no more than 350 N/mm2, o 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 vessel must be appropriate to and compatible with the materials to be welded. 1.3. Accessories contributing towards the strength of the vessel These accessories (e. g. bolts and nuts) must be made of a material specified in 1.1 or of other kinds of steel, aluminium or an appropriate aluminium alloy compatible with materials used for the manufacture of pressurized parts. The latter materials must at minimum working temperature have an appropriate elongation after rupture and toughness. 1.4. Non-pressurized parts All unpressurized 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: • the minimum working temperature Tmin, • the maximum working temperature Tmax, • the maximum working pressure PS. However, should a minimum working temperature exceeding − 10 ºC be selected, the qualities required of the materials must be satisfied at −10 ºC. 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 shall be maintained throughout the period of use of the vessel for the intended purpose, • the vessels shall, bearing in mind their prescribed use, be adequately protected against corrosion, and the fact that under the conditions of use envisaged, • the vessels will not be subjected to stresses likely to impair their safety in use, • internal pressure will 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 shall have a cylindrical edge. 2.1. Wall thickness If the product PS.V is not more than 3 000 bar/litre, the manufacturer must select one of the methods described in 2.1.1 and 2.1.2 for determining vessel wall thickness; if the product of PS and V is more than 3 000 bar/litre, or if the maximum working temperature exceeds100 ºC, such thickness must be determined by the method described in 2.1.1. Source: CBI Market Information Database • URL: www.cbi.nl • Contact: [email protected] • www.cbi.nl/disclaimer Page 5 of 11

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. 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 simple pressure vessels, see step 6. For a list of notified bodies, click here.  Please note: • Simple pressure vessels may be incorporated in other equipment. If other Directives apply, other notified bodies may be involved. It is recommended to look at the entire process when selecting a notified body, since communication between notified bodies for different Directives may be necessary. • 10 practical tips on how to select a notified body are given in the basic document explaining the steps. See the related document on the 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 should contain the documentation on how the conformity has been achieved. If the Directive requires a verification of the file, for example when the product has to be submitted to an EC type approval, this file will be checked together with the product or separately. Besides general information like name and address of the manufacturer, identification of the product, drawings and overviews of the product, all relevant detailed information on the design, construction and testing, risk assessment, certificates, applied standards, a description of the preventive measures and a copy of the user manual must be included. This includes the following instructions which are given in Annex II, clause 2 of the Directive: • The particulars given in 1 above except for the vessel’s serial identification, • The intend use of the vessel, • The maintenance and installation requirements for vessel safety. Please note that they must be in the official language or languages of the country of destination.

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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. According to Directive 87/404/EEC, Article 8, pressure vessels of which the product of PS and V exceeds 50 bar/litre and that fully comply with the harmonized standards, must be: • either reported to a Notified Body, which after examining the design and manufacturing schedule referred to in Annex II 3, shall draw up a certificate of adequacy attesting that the schedule is satisfactory, or • submit a prototype vessel for the EC type-examination referred to in Article 10.  Please note: If the pressure vessels do not entirely meet the requirements of the harmonized standards, a prototype of the vessel must be submitted for the EC typeexamination referred to in Article 10. The following issues of Article 10 on EC type-examination must be taken into account: 1. EC type-examination is the procedure by which 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 authorized representative with a single approved inspection body in respect of a prototype vessel or of a prototype representing a family of vessels. That authorized representative must be established in the EU. The application shall include: • the name and address of the manufacturer or of his authorized representative and the place of manufacture of the vessels, • the design and manufacturing schedule referred to in Annex II 3 of the Directive. It shall be accompanied by a vessel which is representative of the production envisaged. 3. The approved body shall carry out the EC type-examination in the manner described below. 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 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 bodies and the other EU 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. A body which refuses to issue an EC type-examination certificate shall so inform the other approved bodies. A body which withdraws an EC type-examination certificate shall so inform the EU Member State which approved it. The latter shall inform the other EU member States and the Commission thereof, giving the reasons for the decision.

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The EU designed flow charts for all Directives with the process of the so-called “conformity assessment”. You can find the flow chart for simple pressure vessels in Annex A of this document. Click ( Flow Chart). It is recommended to print this page. Annex II, clause 3, reads: The design and manufacturing schedules must contain a description of the techniques and operations employed in order to meet the essential requirements referred to in Article 3 or the standards referred to in article 5 (1) and in particular: • a detailed manufacturing drawing of the vessel type; • the instructions; • 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 used, the schedule must also include: • the certificates relating to the suitable qualification of the welding operations and of the welders or operators; • the inspection slip for the materials used in the manufacture of parts and assemblies contributing to the strength of the pressure vessel; • a report on the examinations and tests performed or a description of the proposed checks. Step 7 – Draw up an EC Declaration of Conformity 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. The manufacturer declares conformity to the design and manufacturing schedule referred to in Annex II, section 3, and on which a certificate of adequacy has been drawn up, or an approved prototype. Step 8 – Draw up a file in which the production process is described, and, if required in the relevant Directive(s), submit the production process to a quality control procedure as describes in the Directive(s) To ensure that each product will be the same as the model that has been approved, the production process must be described. For many Directives, this is an obligation. According to Directive 87/404/EEC, Article 8, the manufacturer of pressure vessels of which the product of PS and V exceeds 50 bar/litre, that do not fully comply with the harmonized standards, are already submitted to the EC-type examination (step 5), and do not require additional quality assurance procedures. The manufacturer of pressure vessels of which the product of PS and V exceeds 3000 bar/litre, that fully comply with the harmonized standards, must submit these pressure vessels to the EC verification referred to in Article 11. Where the product of PS and V does not exceed 3000 bar litre but exceeds 50 bar/litre, these manufacturer must either: • issue an EC declaration of conformity referred to in Article 12, or • submit the pressure vessels to the EC verification referred to in Article 11.

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Step 9 - Affix the CE marking Finally, the CE marking has to be affixed to the product. It must be clearly readable and irremovable attached to the product. Besides the CE marking, the name and address, serial or type indication, as well as the production year of the product have to be mentioned on the product. 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 note that there is additional marking required: The vessel or data plate must bear the EC mark provided for in Article 16, together with at least the following information: Inscriptions • the maximum working pressure PS in bar • the maximum working temperature T max in °C • the minimum working temperature T min in °C • the capacity of the vessel V in l • the name or mark of the manufacturer • the type and serial or batch identification of the vessel. Where a data plate is used, it must be so designed that it cannot be re-used and must include a vacant space to enable other information to be provided. Symbol

Unit

A

elongation after rupture (Lo = 5,65 So)

%

A

80 mm elongation after rupture (Lo = 80 mm)

%

KCV

rupture energy

J/cm2

P

design pressure

bar

PS

working pressure

bar

Ph

hydrostatic or pneumatic test pressure

bar

Rp0,2

proof stress at 0,2 %

N/mm2

RET

yield strength at maximum working temperature

N/mm2

ReH

upper yield point

N/mm2

Rm

tensile strength

N/mm2

Tmax

maximum working temperature

ºC

Tmin

minimum working temperature

ºC

V Rm, max Rp1,0

capacity of the vessel maximum tensile strength proof stress at 1,0 %

L N/mm2 N/mm2

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Step 10 - Monitor the production process, the development of legislation and standards After affixing the CE marking, make sure that the conformity is maintained. The 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. New and revised standards do not influence the validity of the CE marking and the EC Declaration of Conformity.

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Annex A:

Flow chart Click (

back to the text)

Last updated: January 2006

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