DIRECTIVE 2014/68/EU Pressure Equipment
1. This Directive shall apply to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0,5 bar.
2. This Directive shall not apply to:
(a) 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 shall not apply to standard pressure equipment such as may be found in pressure reduction stations or compression stations;
(b) 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;
(c) simple pressure vessels covered by Directive 2014/29/EU of the European Parliament and of the Council ( 1 );
(d) aerosol dispensers covered by Council Directive 75/324/EEC ( 2 );
(e) equipment intended for the functioning of vehicles defined by the following legal acts:
(i) Directive 2007/46/EC of the European Parliament and of the Council ( 3 );
(ii) Regulation (EU) No 167/2013 of the European Parliament and of the Council ( 1 );
(iii) Regulation (EU) No 168/2013 of the European Parliament and of the Council ( 2 );
(f) equipment classified as no higher than category I under Article 13 of this Directive and covered by one of the following Directives:
(i) Directive 2006/42/EC of the European Parliament and of the Council ( 3 );
(ii) Directive 2014/33/EU of the European Parliament and of the Council ( 4 );
(iii) Directive 2014/35/EU of the European Parliament and of the Council ( 5 );
(iv) Council Directive 93/42/EEC ( 6 );
(v) Directive 2009/142/EC of the European Parliament and of the Council ( 7 );
(vi) Directive 2014/34/EU of the European Parliament and of the Council ( 8 );
(g) equipment covered by point (b) of Article 346(1) TFEU;
(h) items specifically designed for nuclear use, failure of which may cause an emission of radioactivity;
(i) 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 shall comprise the wellhead (Christmas tree), the blow out preventers (BOP), the piping manifolds and all their equipment upstream;
(j) 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:
(i) engines including turbines and internal combustion engines;
(ii) steam engines, gas/steam turbines, turbo-generators, compressors, pumps and actuating devices;
(k) 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, iron and non-ferrous metals;
(l) enclosures for high-voltage electrical equipment such as switchgear, control gear, transformers, and rotating machines;
(m) pressurised pipes for the containment of transmission systems, e.g. for electrical power and telephone cables;
(n) ships, rockets, aircraft and mobile off-shore units, as well as equipment specifically intended for installation on board or the propulsion thereof;
(o) pressure equipment consisting of a flexible casing, e.g. tyres, air cushions, balls used for play, inflatable craft, and other similar pressure equipment;
(p) exhaust and inlet silencers;
(q) bottles or cans for carbonated drinks for final consumption;
(r) 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;
(s) equipment covered by Directive 2008/68/EC and Directive 2010/35/EU and equipment covered by the International Maritime Dangerous Goods Code and the Convention on International Civil Aviation;
(t) radiators and pipes in warm water heating systems;
(u) vessels designed to contain liquids with a gas pressure above the liquid of not more than 0,5 bar.
Classification of pressure equipment
1. Pressure equipment referred to in Article 4(1) shall be classified by category in accordance with Annex II, according to an ascending level of hazard.
For the purposes of such classification fluids shall be divided into the following two groups:
(a) group 1 consisting of substances and mixtures, as defined in points (7) and (8) of Article 2 of Regulation (EC) No 1272/2008, that are classified as hazardous in accordance with the following physical or health hazard classes laid down in Parts 2 and 3 of Annex I to that Regulation:
(i) unstable explosives or explosives of Divisions 1.1, 1.2, 1.3, 1.4 and 1.5;
(ii) flammable gases, category 1 and 2;
(iii) oxidising gases, category 1;
(iv) flammable liquids, category 1 and 2;
(v) flammable liquids, category 3 where the maximum allowable temperature is above the flashpoint;
(vi) flammable solids, category 1 and 2;
(vii) self-reactive substances and mixtures, type A to F;
(viii) pyrophoric liquids, category 1;
(ix) pyrophoric solids, category 1;
(x) substances and mixtures which in contact with water emit flammable gases, category 1, 2 and 3;
(xi) oxidising liquids, category 1, 2 and 3;
(xii) oxidising solids, category 1, 2 and 3;
(xiii) organic peroxides types A to F;
(xiv) acute oral toxicity, category 1 and 2;
(xv) acute dermal toxicity, category 1 and 2;
(xvi) acute inhalation toxicity, category 1, 2 and 3;
(xvii) specific target organ toxicity – single exposure, category 1.
Group 1 comprises also substances and mixtures contained in pressure equipment with a maximum allowable temperature TS which exceeds the flashpoint of the fluid;
(b) group 2 consisting of substances and mixtures not referred to in point (a).
2. Where a vessel is composed of a number of chambers, it shall be classified in the highest category applicable to the individual chambers. Where a chamber contains several fluids, classification shall be on the basis of the fluid which requires the highest category.
Conformity assessment procedures
1. The conformity assessment procedures to be applied to an item of pressure equipment shall be determined by the category, as set out in Article 13, in which the equipment is classified.
2. The conformity assessment procedures to be applied for the various categories are the following:
(a) category I:
— Module A
(b) category II:
— Module A2
— Module D1
— Module E1
(c) category III:
— Modules B (design type) + D
— Modules B (design type) + F
— Modules B (production type) + E
— Modules B (production type) + C2
— Module H
(d) category IV:
— Modules B (production type) + D
— Modules B (production type) + F
— Module G
— Module H1
The conformity assessment procedures are set out in Annex III.
3. Pressure equipment shall be subject 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.
4. In the framework of quality assurance procedures for pressure equipment in categories III and IV referred to in point (i) of point (a) of Article 4(1), first indent of point (ii) of point (a) of Article 4(1) and point (b) of Article 4(1), 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, point 3.2. 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 point 4.4 of modules D, E and H and point 5.4 of module H1.
5. In the case of one-off production of vessels and pressure equipment in category III referred to in point (b) of Article 4(1) under the module H procedure, the notified body shall perform or have performed the final assessment, as referred to in point 3.2 of Annex I, for each unit. To this end, the manufacturer shall communicate the intended schedule of production to the notified body.
6. Assemblies referred to in Article 4(2) shall be subject to a global conformity assessment procedure comprising the following assessments:
(a) the assessment of each item of pressure equipment making up the assembly and referred to in Article 4(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;
(b) the assessment of the integration of the various components of the assembly as referred to in points 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;
(c) the assessment of the protection of an assembly against exceeding the permissible operating limits as referred to in points 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.
7. By way of derogation from paragraphs 1 and 2 of this Article, the competent authorities may, where justified, allow the making available 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 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.
8. The records and correspondence relating to conformity assessment procedures shall be drafted in an official language of the Member State where the body responsible for carrying out these conformity assessment procedures is established, or in a language accepted by that body.
EU declaration of conformity
1. The EU declaration of conformity shall state that the fulfilment of essential safety requirements set out in Annex I has been demonstrated.
2. The EU declaration of conformity shall have the model structure set out in Annex IV and shall contain the elements specified in the relevant conformity assessment procedures set out in Annex III and shall be continuously updated. It shall be translated into the language or languages required by the Member State in whose market the pressure equipment or assembly is placed or made available on the market.
3. Where pressure equipment or an assembly is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned including their publication references.
4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the pressure equipment or assembly with the requirements laid down in this Directive.
Rules and conditions for affixing the CE marking
1. The CE marking shall be affixed visibly, legibly and indelibly to any of the following:
(a) each item of pressure equipment referred to in Article 4(1) or its dataplate;
(b) each assembly referred to in Article 4(2) or its dataplate.
Where the affixing of the CE marking is not possible or not warranted on account of the nature of the equipment or assembly, it shall be affixed to the packaging and to the accompanying documents.
The item or assembly referred to in points (a) and (b) of the first subparagraph shall be complete or shall be in a state permitting final assessment as described in point 3.2 of Annex I.
2. It is not necessary for the CE marking to be affixed to each individual item of pressure equipment making up an assembly. Individual items of pressure equipment already bearing the CE marking when incorporated into the assembly shall continue to bear that marking.
3. The CE marking shall be affixed before the item of pressure equipment or the assembly is placed on the market.
4. The CE marking shall be followed by the identification number of the notified body, where that body is involved in the production control phase.
The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.
5. The CE marking and, where applicable, the identification number referred to in paragraph 4 may be followed by any other mark indicating a special risk or use.
6. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
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