Government Regulation No. 219 / 2016 Coll.
Government Regulation on conformity assessment of pressure equipment when making them available on the market
Valid
Regulation
Effective from 19.07.2016
Text versions:
19.07.2016
18.07.2016
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219
GOVERNMENT REGULATION
of 7 July 2016
on conformity assessment of pressure equipment when making them available on the market
The Government mandates, pursuant to Sections 4 and 50 (5) of Act No. 90 / 2016 Coll., on the conformity assessment of specified products when making them available on the market ("the Act '):
Subject matter
(1) This Regulation implements the relevant European Union1 Regulation and regulates the technical requirements for pressure equipment which they must meet when placing on the market, the conditions and procedures for making them available on the market and the means of conformity assessment.
(2) This Regulation shall apply to design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum permissible pressure PS of more than 0,5 bar.
(3) This Regulation shall not apply to:
(a) long-distance piping lines consisting of a pipe or a pipe system intended for the transport of fluid or substance to or from pressure equipment situated on land or sea; Extreme sealing devices, located in the circuit of the pressure equipment, are part of the long-distance line, all connected devices designed separately for the piping line; the exemption provided for in this point shall not apply to standard pressure equipment which may be found in reduction or compression stations;
(b) networks for the supply, distribution and discharge of water and associated facilities and supply channels such as supply pressure lines, pressure stalls, pressure shafts for hydropower plants and associated specific accessories;
(c) simple pressure vessels 2),
(d) aerosol dispensation3),
(e) equipment intended for the operation of vehicles under other legislation4) or directly applicable European Union5) governing the approval of vehicles;
(f) equipment which, pursuant to Article 4, is classified in category I at the most and is one of the products under other legislations6),
(g) equipment intended for use as weapons, ammunition or war material;
(h) equipment specially designed for use in nuclear installations the failure of which may cause a radioactive spill;
(i) well control equipment used in the oil, gas or geothermal exploration and quarrying industry and for underground storage tanks designed to maintain or control well pressure; Drill control devices are, in particular, well-opening devices, which are an eruption cross, anti-eruption devices, distribution lines and all the devices which are assigned to them;
(j) equipment containing bodies or components the dimensioning, material selection and production rules of which are based primarily on the requirements of sufficient strength, rigidity and stability with regard to static and dynamic operational stress or other operational characteristics and for which pressure is not a significant design factor; These facilities are in particular:
1. engines, including turbines and internal combustion engines; or
2. steam engines, gas or steam turbines, turbogenerators, compressors, pumps and their control equipment;
(k) blast furnaces, including their cooling system, wind heaters, dust separators and blast furnace cleaners, direct reduction shaft kilns, including furnace cooling equipment, gas converters and ladles for melting, melting, degasification and casting of steel, iron and non-ferrous metals;
(l) cabinets for high voltage electrical equipment such as switching equipment, control and control equipment, transformers and rotary machines,
(m) pressure pipes for the storage of transmission systems such as electric power cables and telephone cables;
(n) ships, rockets, aircraft and mobile equipment at sea, as well as equipment specially designed for installation on or propulsion on their deck;
(o) pressure equipment consisting of a flexible casing, these devices are in particular tyres, air pillows, balls, inflatable boats and other similar pressure equipment;
(p) exhaust absorbers and suction,
(q) bottles or cans for aerated drinks intended for final consumption;
(r) containers intended for the transport and distribution of beverages, the product of which does not exceed 500 bar, the maximum permissible pressure of which does not exceed 7 bar;
(s) equipment covered by other legislation7) and equipment covered by the International Maritime Organisation Code on the Carriage of Dangerous Goods by Sea;
t) heating bodies and pipes of heating systems; and
(u) containers intended for the collection of liquids where the pressure of gas above the liquid is not more than 0,5 bar.
Definition of terms
For the purposes of this Regulation:
(a) pressure equipment of the container, pipes, safety equipment and pressure equipment, including elements attached to the components subjected to pressure such as flanges, throats, couplings, support, hanging eyes;
(b) a vessel designed and constructed in such a way that it can be filled with liquid under pressure, including components directly attached to it and extending to the point of contact with another device; The container may consist of more than one pressure chamber,
(c) piping of the piping part intended for the transport of liquids, provided that they are connected in such a way that they form one pressure system; The pipe includes, in particular, tubes or assemblies of tubes or pipes, fittings, dilation joints, hoses or, where appropriate, other parts of the pressure applied; heat exchangers consisting of tubes intended for cooling or heating air shall also be considered as pipes,
(d) safety fittings for devices designed to protect pressure equipment from exceeding the maximum permitted limits, including devices for direct pressure limitation, such as safety valves, membrane safety devices, lifting rods, controlled safety systems, and restrictive devices which either activate correction devices or provide shut-down or unlocking devices such as pressure switches, temperature switches or level switches and measuring, control and control equipment related to safety;
(e) pressure equipment of equipment having an operational function and whose body is under pressure;
(f) pressure that is related to atmospheric pressure resulting in negative pressure;
(g) the maximum permissible pressure specified by the manufacturer as the highest pressure for which the pressure equipment is designed and which is defined at a specified point where the protective or limiting device is attached, or at the highest point of the pressure equipment, or at any other specified point where the maximum permissible pressure is marked with the letters PS;
(h) the highest and, where applicable, the lowest temperature permitted by the manufacturer, the highest and, where applicable, the lowest temperature for which the pressure equipment is designed, the highest and lowest permissible temperature being marked with the letters TS;
(i) the volume of the internal volume of each pressure chamber, including the volume of the throats up to the first coupling or weld, after deduction of the volume of the permanent internal components, the volume being marked with the letter V;
(j) the nominal luminous intensity of the numeric size marking common to all parts of the pipe system, unless it is marked with an external diameter or thread size, for reference reasons being a rounded number which is only approximately related to the production dimensions; the nominal luminous intensity is denoted by the letters DN followed by the number,
(k) liquid gases, liquids and vapours, both in the form of a pure phase and in a mixture, the liquid may contain a suspension of solids;
(l) unbreakable connections of connections which cannot be unconnected in any way other than destructive;
(m) a European approval for materials with a technical document defining the characteristics of materials intended for reuse in the manufacture of pressure equipment to which no harmonised standard applies;
(n) the manufacturer also produces the pressure equipment or assembly or has the pressure equipment or assembly designed or manufactured and uses it for its own use;
(o) the technical specification of the document which prescribes the technical requirements to be met by the pressure equipment or assembly.
Technical requirements for pressure equipment
(1) The technical requirements for pressure equipment are the essential safety requirements set out in Annex 1 to this Regulation, the fulfilment of which is demonstrated by conformity assessment.
(2) The technical requirements must be met for:
(a) containers other than those referred to in (b) intended for:
1. gases, liquefied gases, gases dissolved under pressure, vapours, as well as liquids whose vapour pressure at the highest permitted temperature is more than 0,5 bar above the normal atmospheric pressure of 1 013 mbar, within the following limits:
1.1 for fluids of group 1, if the volume is greater than 1 L and the product of PS V greater than 25 bar, or PS pressure greater than 200 bar according to Annex 2, Figure 1, to this Regulation; or
1.2 for fluids of group 2, if the volume is greater than 1 L and the product of PS In more than 50 bar EAL or PS pressure greater than 1000 bar, and all portable fire extinguishers and breathing apparatus bottles as specified in Annex 2, Figure 2, to this Regulation; and
2. liquids whose vapour pressure at the highest permitted temperature does not exceed the normal atmospheric pressure of 1 013 mbar by more than 0,5 bar, within the following limits:
2.1 for fluids of Group 1, if the volume is greater than 1 L and the product of PS, V greater than 200 bar, or PS pressure greater than 500 bar as defined in Annex 2, Figure 3 to this Regulation; or
2.2 for fluids of group 2, if the pressure of PS is greater than 10 bar and the product of PS. V greater than 10 000 bar, or PS pressure greater than 1 000 bar according to Annex 2, Figure 4, to this Regulation,
(b) pressure equipment exposed to flame or otherwise heated with the risk of overheating, intended for the production of steam or hot water at temperatures above 110 ° C and having a volume greater than 2 L, and for all pressure cookers as specified in Annex 2, Figure 5, to this Regulation;
(c) pipes intended for:
1. gases, liquefied gases, gases dissolved under pressure, vapours and liquids whose vapour pressure at the highest permitted temperature is more than 0,5 bar above the normal atmospheric pressure of 1 013 mbar, within the following limits:
1.1 for Group 1 fluids, if DN is more than 25 (Figure 6 of Annex 2 to this Regulation), or
1.2 for Group 2 fluids, if DN is greater than 32 and PS is greater than 1 000 bar according to diagram 7 of Annex 2 to this Regulation; and
2. liquids whose vapour pressure at the highest permitted temperature does not exceed the normal atmospheric pressure of 1 013 mbar by more than 0,5 bar, within the following limits:
2.1 for Group 1 fluids, if DN is more than 25 and PS is greater than 2 000 bar according to Annex 2, Chart 8, to this Regulation; or
2.2 for Group 2 fluids, if PS is greater than 10 bar, DN is greater than 200 and PS is greater than 5000 bar according to Figure 9 of Annex 2 to this Regulation; and
(d) safety and pressure equipment intended for pressure equipment covered by (a), (b) or (c), including pressure equipment incorporated in the assembly.
(3) In addition, the technical requirements shall be met for assemblies containing at least one pressure equipment covered by paragraph 2 as regards:
(a) assemblies intended for the production of steam or hot water at temperatures above 110 ° C containing at least one pressure device exposed to flame or otherwise heated, where there is a risk of overheating; or
(b) assemblies other than those referred to in (a), where the manufacturer is intended to be made available on the market and put into service as assemblies.
(4) By way of derogation from paragraph 3 (a), the assemblies intended for the production of hot water at temperatures not exceeding 110 ° C, in which a solid fuel is manually incorporated and the product of PS-V exceeds 50 bar L, shall comply with the essential safety requirements set out in points 2.10, 2.11 and 3.4 and in points 5 (a) and (d) of Annex 1 to this Regulation.
(5) Pressure equipment and assemblies with values lower or equal to the limits laid down in paragraph 2 (a), (b) or (c) and paragraph 3 must be designed and manufactured in accordance with good technical practice applied in one of the Member States of the European Union in order to ensure their safe use. Such pressure equipment and assemblies shall be accompanied by instructions for use. Without prejudice to government regulations and European Union harmonisation legislation governing the placing of the CE marking, such establishments and assemblies shall not bear the CE marking.
Classification of pressure equipment
(1) Pressure equipment provided for in Section 3 (2) is classified in categories in accordance with Annex 2 to this Regulation, depending on hazard. For the purposes of this classification, fluids shall be divided into:
(a) Group 1 which includes substances and mixtures contained in pressure equipment with the highest permitted temperature exceeding the point of ignition of the liquid; This group consists of substances and mixtures the definitions of which are set out in Article 2 (7) and (8) of Regulation (EC) No 1272 / 2008 and which are classified as dangerous according to the following physical or health hazards classes set out in Parts 2 and 3 of Annex I to Regulation (EC) No 1272 / 2008:
1. unstable explosives or explosives of sub-classes 1.1, 1.2, 1.3, 1.4 and 1.5;
2. flammable gases of categories 1 and 2;
3. oxidising gases of category 1,
4. flammable liquids of categories 1 and 2;
5. flammable liquids of category 3, if the maximum permissible temperature is higher than the flash point;
6. flammable solids of categories 1 and 2;
7. self-reactive substances and mixtures of types A to F,
8. self-ignition liquids of category 1,
9. self-ignition solids of category 1,
10. substances and mixtures which, in contact with water, release flammable gases, categories 1, 2 and 3;
11. oxidising liquids of categories 1, 2 and 3,
12. oxidising solids of categories 1, 2 and 3,
13. organic peroxides of types A to F,
14. Acute oral toxicity categories 1 and 2,
15. Acute dermal toxicity categories 1 and 2,
16. Acute inhalation toxicity categories 1, 2 and 3; and
17. Specific target organ toxicity - single exposure category 1; and
(b) Group 2 consisting of substances and mixtures not referred to in (a).
(2) If the container consists of several pressure areas, it shall be classified according to the highest category applicable to each pressure area. If the pressure chamber contains several fluids, the classification shall be based on the liquid that requires the highest category.
Making available on the market and putting into service
(1) Pressure equipment and assemblies may be made available on the market and put into service under the conditions specified by the manufacturer only if they comply with the requirements laid down in this Regulation and are correctly installed, maintained and used for the intended purpose.
(2) At trade fairs, exhibitions and other similar events or at demonstration, pressure equipment or assemblies which are not in conformity with this Regulation may be demonstrated, provided that it is clear from the visible sign that those pressure equipment or assemblies are not in conformity and must not be made available on the market or put into service until they have been brought into conformity. Safety measures shall be taken to ensure the safety of persons when demonstrating.
Manufacturer
(1) When placing pressure equipment or assemblies on the market or when using them for its own use, the manufacturer shall ensure:
(a) in the case of pressure equipment or assemblies provided for in Article 3 (2) and (3), that such equipment or assemblies are designed and manufactured in accordance with technical requirements; and
(b) for pressure equipment or assemblies provided for in Article 3 (5), such equipment or assemblies shall be designed and manufactured in accordance with good technical practice.
(2) In the case of pressure equipment or assemblies provided for in Sections 3 (2) and 3, the manufacturer shall draw up the technical documentation set out in Annex 3 to this Regulation and carry out or have carried out the conformity assessment procedure set out in Section 11. Where compliance of those pressure equipment or assemblies with the relevant requirements has been demonstrated by the relevant conformity assessment procedure, the manufacturer shall draw up an EU declaration of conformity and place it on the pressure equipment or assembly of the CE marking.
(3) The manufacturer shall keep the technical documentation and the EU declaration of conformity for 10 years after the pressure equipment or assembly has been placed on the market.
(4) The manufacturer shall ensure that the pressure equipment or assemblies bear a type or batch number or serial number or other element enabling them to be identified, or in cases where the size or nature of the device or assembly does not allow the required information to be shown on the packaging or on the document accompanying the device.
(5) The manufacturer shall indicate on the pressure equipment or assembly, or, if this is not possible, on the packaging or in the document accompanying the device or assembly his name or business name or trade mark, if any, and the address for service at which he can be contacted. The delivery address shall be the address of the place at which the manufacturer can actually be contacted. The contact details shall be given in a language easily understood by end-users and the supervisory authority.
(6) The manufacturer shall ensure that the pressure equipment or assembly referred to in paragraphs 2 and 3 of Section 3 is accompanied by clear and comprehensible instructions and safety information as referred to in points 3.3 and 3.4 of Annex 1 to this Regulation and the pressure equipment or assembly as set out in Section 3 (5) accompanied by clear and understandable instructions and safety information as referred to in Section 3 (5). The instructions and information referred to in points 3.3 and 3.4 of Annex 1 to this Regulation shall be given in the Czech language.
(7) In order to protect the health and safety of end-users, the manufacturer shall carry out tests on pressure equipment samples or assemblies made available on the market and the necessary investigations where necessary in view of the risks posed by pressure equipment or assemblies. These tests and investigations shall be carried out to the extent necessary to confirm or eliminate the existing risk posed by the pressure equipment or assembly in relation to the manufacturer's intended purpose of use. The manufacturer shall keep a register of complaints, non-compliant pressure equipment or assemblies, and shall inform distributors of such activities.
Authorised representative
The authorised representative shall keep the EU declaration of conformity and the technical documentation at the disposal of the supervisory authority for 10 years after the pressure equipment or assembly has been placed on the market.
Importer
(1) Before placing on the market the pressure equipment or assembly provided for in paragraphs 2 and 3 of Article 3, the importer shall ensure that the manufacturer carries out the conformity assessment procedure in accordance with paragraph 11, that the manufacturer produces technical documentation, that the pressure equipment or assembly bears the CE marking, that it is accompanied by instructions and safety information in accordance with points 3.3 and 3.4 of Annex 1 to this Regulation and that the manufacturer complies with the requirements set out in paragraphs 6 (4) and (5).
(2) Before placing on the market the pressure equipment or assembly provided for in Article 3 (5), the importer shall ensure that the manufacturer draws up a technical file, that the pressure equipment or assembly is accompanied by instructions for use and that the manufacturer complies with the requirements set out in Article 6 (4) and (5).
(3) The importer shall indicate on the pressure equipment or assembly, or, if this is not possible, on the packaging or on the document accompanying the device or assembly his name or business name, trade mark and, where appropriate, the address of service at which he can be contacted. The contact details shall be given in a language easily understood by end-users, other users and the supervisory authority.
(4) The importer shall ensure that the pressure equipment or assemblies provided for in Sections 3 (2) and 3 are accompanied by instructions and safety information in accordance with points 3.3 and 3.4 of Annex No 1 to this Regulation in the Czech language and the pressure equipment or assemblies referred to in Section 3 (5) are accompanied by instructions and safety information in the Czech language.
(5) The importer shall, in order to protect the health and safety of end-users, carry out tests on samples of pressure equipment or assemblies made available on the market and the necessary investigations where necessary in view of the risks posed by pressure equipment or assemblies. These tests and investigations shall be carried out to the extent necessary to confirm or eliminate the existing risk posed by the pressure equipment or assembly in relation to the manufacturer's intended purpose of use. The importer shall keep a register of complaints, non-compliant pressure equipment or assemblies, and shall keep distributors informed of such activities.
(6) The importer shall keep a copy of the EU declaration of conformity at the disposal of the supervisory authority for 10 years after the pressure equipment or assembly has been placed on the market and shall ensure that technical documentation can be submitted to the supervisory authority upon request.
Distributor
(1) Before making the pressure equipment or assembly provided for in § 3 (2) and (3) available on the market, the distributor shall verify that:
(a) the pressure equipment or assembly bears the CE marking;
(b) the pressure equipment or assembly is accompanied by the required documentation and instructions and safety information in accordance with points 3.3 and 3.4 of Annex 1 to this Regulation in the Czech language; and
(c) manufacturers and importers have complied with the requirements set out in Articles 6 (4) and (5) and 8 (3).
(2) Before making the pressure equipment or assembly referred to in Article 3 (5) available on the market, the distributor shall verify that:
(a) the pressure equipment or assembly is accompanied by instructions for use in the Czech language; and
(b) the manufacturers and importers have complied with the requirements laid down in Articles 6 (4) and (5) and 8 (3).
Economic operator identification time
The operator shall keep for a period of 10 years after the delivery of the pressure equipment or assembly on the market the data by which, at the request of the supervisory authority, the operator who supplied the pressure equipment or assembly or the pressure equipment or assembly can be identified.
Conformity assessment procedures
(1) The conformity assessment procedures for pressure equipment are set out in Annex 3 to this Regulation. These procedures are determined according to the category to which the installation is classified in accordance with Section 4. The following procedures shall apply to each category:
(a) category I
internal production control (module A) set out in Part 1 of Annex 3 to this Regulation;
(b) Category II
1. internal production control with supervised pressure equipment checks at random intervals (Module A2) set out in Part 2 of Annex 3 to this Regulation;
2. the quality assurance of the production process (module D1) set out in Part 6 of Annex 3 to this Regulation; or
3. the quality assurance of the output control and pressure equipment tests (module E1) set out in Part 8 of Annex 3 to this Regulation;
(c) Category III
1. the EU type-examination (Module B) - the EU type-examination set out in point 3.1 of Part 3 of Annex 3 to this Regulation, and at the same time one of the following procedures:
1.1. Conformity to type based on the quality assurance of pressure equipment (module E) set out in Part 7 of Annex 3 to this Regulation; or
1.2. Conformity to type based on internal production control with supervised pressure equipment checks at random intervals (Module C2) as set out in Part 4 of Annex 3 to this Regulation,
2. EU type-examination (Module B) - EU design type-examination as set out in point 3.2 of Part 3 of Annex 3 to this Regulation and at the same time one of the following procedures:
2.1. Conformity to the type based on the quality assurance of the production process (module D) set out in Part 5 of Annex 3 to this Regulation; or
2.2. Conformity to type based on the verification of pressure equipment (Module F) set out in Part 9 of Annex 3 to this Regulation; or
3. conformity based on the full quality assurance (module H) set out in Part 11 of Annex 3 to this Regulation;
(d) Category IV
1. the EU type-examination (Module B) - the EU type-examination set out in point 3.1 of Part 3 of Annex 3 to this Regulation, and at the same time one of the following procedures:
1.1. Conformity to type based on the quality assurance of the production process (Module D) set out in Part 5 of Annex 3 to this Regulation; or
1.2. Conformity to type based on the verification of pressure equipment (Module F) set out in Part 9 of Annex 3 to this Regulation,
2. conformity based on the verification of each product (Module G) set out in Part 10 of Annex 3 to this Regulation; or
3. conformity based on full quality assurance with design review (module H1) set out in Part 12 of Annex 3 to this Regulation.
(2) The manufacturer may choose one of the procedures laid down for the category to which the pressure equipment is classified. The manufacturer may also use one of the procedures applicable to the higher category.
(3) In the framework of the quality assurance procedures for pressure equipment of categories III and IV set out in points 1, 3 (2) (a) (2.1) and 3 (2) (b) of Section 3 (2), the notified body shall, during an unannounced inspection visit, take a sample of the equipment in the production or storage premises to carry out or have made a final assessment in accordance with point 3.2 of Annex 1 to this Regulation. To this end, the manufacturer shall notify the notified body of the intended production schedule. During the first year of production, the notified body shall make at least 2 visits to the manufacturer. The frequency of subsequent visits by the manufacturer shall be determined by the notified body on the basis of the criteria set out in points 4.4 of modules D, E and H and in point 5.4 of module H1 of Annex 3 to this Regulation.
(4) In the case of unit production of containers and pressure equipment of category III as provided for in Section 3 (2) (b), the notified body shall carry out or have carried out the final assessment referred to in point 3.2 of Annex 1 to this Regulation for each individual installation in accordance with the procedure referred to in Module H. To this end, the manufacturer shall notify the notified body of the intended production schedule.
(5) The assemblies referred to in Article 3 (3) are subject to a procedure for overall conformity assessment which includes the following assessments:
(a) the assessment of each of the pressure equipment provided for in Article 3 (2), of which the assembly consists and which has not previously been subjected to the conformity assessment procedure and the CE marking; the assessment procedure is given by the categories of each installation;
(b) an assessment of the integration of the various components into the assembly referred to in points 2.3, 2.8 and 2.9 of Annex 1 to this Regulation; the assessment shall be carried out in respect of the highest category applicable to the installations concerned, without regard to safety equipment; or
(c) an assessment of the protection of the assembly against exceeding the permissible operating limits referred to in paragraphs 2.10 and 3.2.3 of Annex 1 to this Regulation; This assessment shall be carried out with regard to the highest category applicable to pressure equipment to be protected.
(6) Documents relating to conformity assessment procedures shall be drawn up in the official language (s) of the Member State of the European Union in which the notified body carrying out the conformity assessment procedures is established or in a language agreed between the manufacturer and that notified body.
European Approval for Materials
(1) A European approval for materials shall be issued by one of the notified bodies, specifically designated for this task, at the request of one or more manufacturers of materials or pressure equipment. The notified body shall establish and implement or have carried out appropriate inspections and tests of the types of material in order to certify their conformity with the relevant requirements of this Regulation. In the case of materials the safe use of which was recognised before 29 November 1999, the notified body shall take into account existing data when certifying conformity.
(2) Before issuing a European approval for materials, the notified body shall inform the Member States and the European Commission by sending them documents demonstrating compliance with the obligations referred to in paragraph 1. Within 3 months of dispatch of these documents, the Member State of the European Union or the European Commission may comment on the matter, stating the reasons for its opinion. The notified body shall issue a European approval for the materials taking into account the comments submitted.
(3) A copy of the European approval for materials must be sent to the Member States of the European Union, notified bodies and to the European Commission, which shall publish and update the references to those approvals in the Official Journal of the European Union.
(4) Where a notified body which has issued a European approval for materials finds that it should not have been issued or where a harmonised standard applies to a given type of material, it shall proceed in accordance with Article 24 (4) of the Act and withdraw the European approval for materials. It shall immediately inform the other Member States of the European Union, notified bodies and the European Commission of any withdrawal of approval.
Presumption of conformity
(1) Where the pressure equipment or assembly provided for in Article 3 (2) and (3) is in conformity with harmonised standards or parts thereof to which references have been published in the Official Journal of the European Union, it shall be deemed to comply with the essential technical requirements to which those standards or parts thereof apply.
(2) Where materials used for the manufacture of pressure equipment or assemblies are in conformity with European approvals for materials to which references have been published in the Official Journal of the European Union in accordance with Article 12 (3), they shall be deemed to comply with the relevant essential technical requirements.
EU declaration of conformity
(1) The EU declaration of conformity demonstrates compliance with the technical requirements set out in Annex 1 to this Regulation.
(2) The EU declaration of conformity shall be drawn up in accordance with the model set out in Annex 4 to this Regulation. The declaration shall contain the information set out in the modules listed in Annex 3 to this Regulation and shall be kept up to date. The EU declaration of conformity shall also be translated into the language (s) required by the Member State of the European Union in which the pressure equipment or assembly is placed or made available on the market.
(3) Where a pressure equipment or assembly is covered by more than one European Union harmonisation regulation providing for the drawing up of an EU declaration of conformity, a single EU declaration of conformity shall be drawn up with references to all those provisions under which conformity has been assessed, including references to their publication. This single EU declaration of conformity may take the form of a component consisting of declarations of conformity issued for each Regulation.
CE marking and other markings
(1) The CE marking to be placed before the pressure equipment or assembly is placed on the market shall be placed visibly, legibly and indelibly
(a) on each pressure equipment referred to in Article 3 (2) or its production label; or
(b) for each assembly referred to in Article 3 (3) or its production label.
(2) Where the location referred to in paragraph 1 is not possible or justified due to the nature of the pressure equipment or assembly, the CE marking shall be placed on the packaging and accompanying documents.
(3) The pressure equipment or assembly referred to in paragraph 1 must be complete or in a state which enables the final assessment set out in point 3.2 of Annex 1 to this Regulation.
(4) The CE marking need not be placed on each individual pressure device forming the assembly. Individual pressure equipment already bearing the CE marking when it is incorporated into the assembly shall continue to bear that marking.
(5) The identification number of the notified body which has participated in the conformity assessment in accordance with Parts 2 and 4 to 12 of Annex 3 to this Regulation shall be affixed by the notified body to the CE marking or by the manufacturer or his authorised representative.
(6) The CE marking and, where appropriate, the identification number referred to in paragraph 5 may be followed by any other mark indicating a specific risk or use.
Formal deficiencies
A formal deficiency shall be considered to be:
(a) the CE marking has been placed in breach of Article 30 of Regulation (EC) No 765 / 2008 of the European Parliament and of the Council of 9 July 2008 laying down requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339 / 93 or Article 15;
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Regulation Information
| Citation | Government Regulation No. 219 / 2016 Coll., on conformity assessment of pressure equipment when making them available on the market |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 18.07.2016 |
|---|---|
| Effective from | 19.07.2016 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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