The Directive 2009/105/EC on simple pressure equipment specifies the essential requirements the product has to meet in order for the manufacturer to affix the CE marking. Simple Pressure Equipment can be described as “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”.
Pressure Equipment Directive Process
Step 1 - Identify the Appropriate Directive or Directives
For the purposes of this Directive:
‘Pressure equipment’ means 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.
What’s not in the scope of the Pressure Equipment Directive?
The following are excluded from the scope of this Directive:
3.1. pipelines comprising piping or a system of piping designed for the conveyance of any fluid or substance to or from an installation (onshore or offshore) starting from and including the last isolation device located within the confines of the installation, including all the annexed equipment designed specifically for pipelines. This exclusion does not apply to standard pressure equipment such as may be found in pressure reduction stations or compression stations;
3.2. networks for the supply, distribution and discharge of water and associated equipment and headraces such as penstocks, pressure tunnels, pressure shafts for hydroelectric installations and their related specific accessories;
3.3. equipment covered by Directive 87/404/EEC on simple pressure vessels;
3.4. equipment covered by Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers
3.5. equipment intended for the functioning of vehicles defined by the following Directives and their Annexes:
- Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers ( 1 ),
- Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors ( 2 ),
- Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two or three-wheel motor vehicles ( 3 );
3.6. equipment classified as no higher than category I under Article 9 of this Directive and covered by one of the following Directives:
- Council Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery ( 4 ),
- European Parliament and Council Directive 95/16/EC of 29 June 1995 on the approximation of the laws of the Member States relating to lifts ( 5 ),
- Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits ( 6 ),
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ( 7 ),
- Council Directive 90/396/EEC of 29 June 1990 on the approximation of the laws of the Member States relating to appliances burning gaseous fuels ( 8 ),
- Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres ( 9 ),
3.7. equipment covered by Article 223 (1) (b) of the Treaty;
3.8. items specifically designed for nuclear use, failure of which may cause an emission of radioactivity;
3.9. well-control equipment used in the petroleum, gas or geothermal exploration and extraction industry and in underground storage which is intended to contain and/or control well pressure. This comprises the wellhead (Christmas tree), the blow out preventers (BOP), the piping manifolds and all their equipment upstream;
3.10. equipment comprising casings or machinery where the dimensioning, choice of material and manufacturing rules are based primarily on requirements for sufficient strength, rigidity and stability to meet the static and dynamic operational effects or other operational characteristics and for which pressure is not a significant design factor. Such equipment may include:
- engines including turbines and internal combustion engines,
- steam engines, gas/steam turbines, turbo-generators, compressors, pumps and actuating devices;
3.11. blast furnaces including the furnace cooling system, hot-blast recuperators, dust extractors and blast-furnace exhaust-gas scrubbers and direct reducing cupolas, including the furnace cooling, gas converters and pans for melting, re-melting, de- gassing and casting of steel and non-ferrous metals;
3.12. enclosures for high-voltage electrical equipment such as switchgear, control gear, transformers, and rotating machines;
3.13. pressurised pipes for the containment of transmission systems, e.g. for electrical power and telephone cables;
3.14. ships, rockets, aircraft and mobile off-shore units, as well as equipment specifically intended for installation on board or the propulsion thereof;
3.15. pressure equipment consisting of a flexible casing, e.g. tyres, air cushions, balls used for play, inflatable craft, and other similar pressure equipment;
3.16. exhaust and inlet silencers;
3.17. bottles or cans for carbonated drinks for final consumption;
3.18. vessels designed for the transport and distribution of drinks having a PS·V of not more than 500 bar·L and a maximum allowable pressure not exceeding 7 bar;
3.19. equipment covered by the ADR ( 1 ), the RID ( 2 ), the IMDG ( 3 ) and the ICAO Convention ( 4 );
3.20. radiators and pipes in warm water heating systems;
3.21. vessels designed to contain liquids with a gas pressure above the liquid of not more than 0,5 bar.
Step 2 - Identify the Applicable Requirements of the CE Directive
In choosing the most appropriate solutions, the manufacturer must apply the principles set out below in the following order:
- eliminate or reduce hazards as far as is reasonably practicable,
- apply appropriate protection measures against hazards which cannot be eliminated,
- where appropriate, inform users of residual hazards and indicate whether it is necessary to take appropriate special measures to reduce the risks at the time of installation and/or use.
Where the potential for misuse is known or can be clearly foreseen, the pressure equipment must be designed to prevent danger from such misuse or, if that is not possible, adequate warning given that the pressure equipment must not be used in that way.
Step 3 - Identify the Appropriate Requirement for Conformity to the CE Directive
Step 4 - Conduct the Assessment of the Product
1.2. The conformity assessment procedures to be applied to an item of pressure equipment with a view to affixing the CE marking shall be determined by the category, as defined in Article 9, in which the equipment is classified.
1.3. The conformity assessment procedures to be applied for the various categories are as follows:
- category I: Module A
- category II: Module A1, Module D1, Module E1
- category III: Module B1 + D, Module B1 + F, Module B + E, Module B + C1, Module H
- category IV: Module B + D, Module B + F, Module G, Module H1
1.4. Pressure equipment shall be subjected to one of the conformity assessment procedures which may be chosen by the manufacturer among those laid down for the category in which it is classified. The manufacturer may also choose to apply one of the procedures which apply to a higher category, if available.
1.5. In the framework of quality assurance procedures for equipment in categories III and IV referred to in Article 3, section 1.1 (a), section 1.1 (b) first indent and section 1.2, the notified body shall, when performing unexpected visits, take a sample of equipment from the manufacturing or storage premises in order to perform, or have performed, the final assessment as referred to in Annex I, section 3.2.2. To this end, the manufacturer shall inform the notified body of the intended schedule of production. The notified body shall carry out at least two visits during the first year of manufacturing. The frequency of subsequent visits shall be determined by the notified body on the basis of the criteria set out in section 4.4 of the relevant modules.
1.6. In the case of one-off production of vessels and equipment in Category III referred to in Article 3, section 1.2 under the module H procedure, the notified body shall perform or have performed the final assessment, as referred to in Annex I, section 3.2.2, for each unit. To this end, the manufacturer shall communicate the intended schedule of production to the notified body.
2. Assemblies referred to in Article 3 (2) shall be subjected to a global conformity assessment procedure comprising:
- assessment of each item of pressure equipment making up the assembly and referred to in Article 3 (1) which has not been previously subjected to a conformity assessment procedure and to a separate CE marking; the assessment procedure shall be determined by the category of each item of equipment;
- the assessment of the integration of the various components of the assembly as referred to in sections 2.3, 2.8 and 2.9 of Annex I which shall be determined by the highest category applicable to the equipment concerned other than that applicable to any safety accessories;
- the assessment of the protection of an assembly against exceeding the permissible operating limits as referred to in sections 2.10 and 3.2.3 of Annex I shall be conducted in the light of the highest category applicable to the items of equipment to be protected.
3. By way of derogation from paragraphs 1 and 2, the competent authorities may, where justified, allow the placing on the market and putting into service in the territory of the Member State concerned of individual pressure equipment items and assemblies referred to in Article 1 (2), in respect of which the procedures referred to in paragraphs 1 and 2 of this Article have not been applied and the use of which is in the interests of experimentation.
4. Records and correspondence relating to conformity assessment shall be drawn up in the official language(s) of the Community which may be determined in accordance with the Treaty by the Member State where the body responsible for carrying out these procedures is established, or in a language accepted by that body.
Step 5 - Compile the Technical Documentation
Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the pressure equipment on the Community market.
The technical documentation must enable an assessment to be made of the conformity of the pressure equipment with the requirements of the Directive which apply to it. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the pressure equipment and contain:
- a general description of the pressure equipment,
- conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
- descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the pressure equipment,
- a list of the standards referred to in Article 5, applied in full or in part, and a description of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,
- results of design calculations made, examinations carried out, etc.,
- test reports.
- When pressure equipment is placed on the market, it must be accompanied, as far as relevant, with instructions for the user, containing all the necessary safety information relating to:
- mounting including assembling of different pieces of pressure equipment,
- putting into service,
- maintenance including checks by the user;
- Instructions must cover information affixed to the pressure equipment in accordance with section 3.3 of the Pressure Equipment Directive, with the exception of serial identification, and must be accompanied, where appropriate, by the technical documents, drawings and diagrams necessary for a full understanding of these instructions;
- If appropriate, these instructions must also refer to hazards arising from misuse in accordance with section 1.3 of the Pressure Equipment Directive and particular features of the design in accordance with section 2.2.3 of the Pressure Equipment Directive.
What safety information must be given to the user in relation to Annex I points 3.3 and 3.4?
When pressure equipment is placed on the market, the manufacturer is required by the PED to ensure that it is accompanied by instructions for the user containing certain safety information; such information is mandatory. Additional information may be requested by the user or recommended by the manufacturer, and agreed as part of the order or contract; this information is not a PED requirement and therefore is optional. Both types of information are elaborated below.
The following are required by the PED:
- Details accompanying the CE mark, per clause 3.3a, 3.3b and 3.3c
- Operating instructions for mounting, putting into service, use and maintenance, per clause 3.4a, which include as far as relevant to the equipment:
- safe operating limits and design basis (includes anticipated operating and assumed design conditions, intended life, design code used, joint coefficients and corrosion allowances)
- features of the design relevant to the life of the equipment per clause 2.2.3b last indent
- residual hazards not prevented by design or protective measures, that might arise from foreseeable misuse, per clause 1.3, 3.3c, and 3.4c
- technical documents, drawings and diagrams necessary for a full understanding of these instructions, as per clause 3.4b
- information about replaceable parts, for example per clause 2.7
Step 6 - Issue Declaration of Conformity and place CE mark on the Product
The manufacturer, or his authorised representative established within the Community, must affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity.
DECLARATION OF CONFORMITY
The EC declaration of conformity must contain the following particulars:
- name and address of the manufacturer or of his authorised representative established within the Community,
- description of the pressure equipment or assembly,
- conformity assessment procedure followed,
- in the case of assemblies, description of the pressure equipment constituting the assembly, and the conformity assessment procedures followed,
- where appropriate, name and address of the notified body which carried out the inspection,
- where appropriate, a reference to the EC type-examination certificate, EC design-examination certificate or EC certificate of conformity,
- where appropriate, name and address of the notified body monitoring the manufacturer’s quality assurance system,
- where appropriate, the references of the harmonised standards applied,
- where appropriate, other technical standards and specifications used,
- where appropriate, the references of the other Community Directives applied,
- particulars of the signatory authorised to sign the legally binding declaration for the manufacturer or his authorised representative established within the Community.
The CE marking shall consist of the initials ‘CE’ taking the following form:
If the CE marking is reduced or enlarged the proportions shown in the above drawing must be respected.
The manufacturer may choose to affix the CE marking visibly, legibly and indelibly to the toy, to an affixed label or to the packaging.
The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm.
The CE marking shall be accompanied by the identification number, as referred to in Article 12 (1), of the notified body involved at the production control phase.
The CE marking shall be affixed in a visible, easily legible and indelible fashion to each
- item of pressure equipment referred to in Article 3 (1), or
- assembly referred to in Article 3 (2)
which is complete or is in a state permitting final assessment as described in section 3.2 of Annex I.
It is not necessary for the CE marking to be affixed to each individual item of pressure equipment making up an assembly as referred to in Article 3 (2). Individual items of pressure equipment already bearing the CE marking when incorporated into the assembly shall continue to bear that marking.
Where the pressure equipment or assembly is subject to other Directives covering other aspects which provide for the affixing of the CE marking, the latter shall indicate that the pressure equipment or assembly in question is also presumed to conform to the provisions of those other Directives.
However, should 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 with the Directives applied by the manufacturer. In this case, the particulars of the said Directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the Directives and accompanying the pressure equipment or assembly.
The affixing of markings on pressure equipment or assemblies which are likely to mislead third parties as to the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to pressure equipment or assemblies provided that the visibility and legibility of the CE marking is not thereby reduced.