Government Regulation No. 116 / 2016 Coll.
Government Regulation on conformity assessment of equipment and protective systems intended for use in potentially explosive atmospheres when making them available on the market
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Regulation
Effective from 20.04.2016
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116
GOVERNMENT REGULATION
of 30 March 2016
on conformity assessment of equipment and protective systems intended for use in potentially explosive atmospheres 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 UnionRegulation (1) and regulates the technical requirements for equipment and protective systems intended for use in potentially explosive atmospheres which they must meet when placed on the market, the conditions and procedures for making them available on the market or for putting them into service and the methods of conformity assessment.
(2) This Regulation shall apply to the following products intended for conformity assessment under Article 4 of the Act (hereinafter referred to as "products'):
(a) equipment and protective systems intended for use in potentially explosive atmospheres;
(b) safety, control and control instruments intended for use outside the potentially explosive environment, but necessary for the safe operation of the products or for their operation; and
(c) components intended for incorporation into products.
(3) This Regulation shall not apply to:
(a) medical devices intended for use in a medical environment;
(b) equipment and protective systems where the risk of explosion results only from the presence of explosives or chemically unstable substances;
(c) equipment intended for use in households and non-business environments where an explosion hazard environment can only exceptionally be created as a result of accidental leakage of heating gas;
(d) personal protective equipment the conformity of which is assessed under another legislation2);
(e) seagoing vessels and mobile coastal objects, including equipment on board such vessels or objects;
(f) means of transport intended solely for the carriage of passengers by air, road, rail or waterway, as well as means of transport intended for the carriage of goods by air, public road or rail or by water, with the exception of vehicles intended for use in potentially explosive environments; and
g. Equipment for the manufacture of weapons, ammunition or military goods.
Definition of terms
This Regulation shall mean:
(a) the manufacturer also produces the product or has the product designed or manufactured and uses it for its own use;
(b) equipment for machinery, apparatus, fixed or mobile equipment, controls and their instrumentation and detection or prevention protection systems intended for the production, transmission, accumulation, measurement, control and conversion of energy or material processing and capable of causing explosion due to their own potential sources of ignition;
(c) protective systems for apparatus other than components of equipment intended for the immediate suppression of the initial stage of explosion or for limiting the extent of the effects of explosion and made available on the market separately and used as independent systems;
(d) components of elements which are important for the safe operation of equipment and protective systems but which do not have an independent function;
(e) by explosive means, a mixture of flammable substances in the form of gases, vapours, fog or dust with air under atmospheric conditions in which, after ignition, the combustion is spread to the whole unburned mixture;
(f) an environment with a risk of explosion which may become explosive due to local and operational conditions;
(g) group of installations I equipment intended for use in the underground parts of the mines and those parts of the surface facilities of those mines which may be threatened by mining gas or combustible dust, including the categories of equipment M 1 and M 2 set out in Annex 1 to this Regulation,
(h) a group of devices II equipment intended for use in other sites which may be endangered by explosive atmospheres, including categories of equipment 1, 2 and 3, as set out in Annex 1 to this Regulation;
(i) the categories of equipment for the classification of installations within each group of installations set out in Annex 1 to this Regulation and defining the required level of protection to be guaranteed;
(j) the intended use of the product prescribed by the manufacturer by incorporating the equipment concerned into a particular group and category of equipment or by providing any information necessary for the safe functioning of the protection system, apparatus or component.
Technical requirements for products
The essential technical requirements for products shall be those laid down in Annex 2 to this Regulation. Compliance with the essential technical requirements shall be demonstrated by conformity assessment.
Making available on the market and putting into service
(1) Products may be made available on the market and put into service only if the requirements of this Regulation are met provided that they are correctly installed, maintained and used for the intended purpose.
(2) At trade fairs, exhibitions and similar demonstrations, products which are not in conformity with this Regulation may be presented if it is clear from a visible sign that they are not in conformity with this Regulation and that they cannot be made available on the market and put into service until the manufacturer has brought them into conformity. Safety measures shall be taken to ensure the protection of persons when performing.
Manufacturer
(1) When placing on the market or using the products for its own use, the manufacturer shall ensure that they are designed and manufactured in accordance with the essential technical requirements, draw up the technical documentation set out in Annexes 3 to 9 to this Regulation and carry out or have carried out the conformity assessment procedure referred to in Article 10.
(2) Where compliance with the essential technical requirements has been demonstrated by the conformity assessment procedure, the manufacturer shall:
(a) the EU declaration of conformity and the CE marking shall be affixed to the non-part product; and
(b) part of the written certificate of conformity referred to in Article 10 (3).
(3) The manufacturer shall keep the technical documentation and the EU declaration of conformity or certificate of conformity for 10 years after the product has been placed on the market.
(4) The manufacturer shall ensure that the product placed on the market bears a type or batch number, serial number or other element enabling it to be identified or, in cases where the size or nature of the product does not allow the information requested to be given on the packaging or on the document accompanying the product. For products which have been placed on the market and which are not part of the product, the manufacturer shall ensure that they bear the special bomb protection marking and, where appropriate, the additional marking and data set out in point 1.0.5 of Annex 2 to this Regulation.
(5) The manufacturer shall indicate on the product, in a language understood by the end-users and the supervisory authority, or, where this is not possible, on the packaging or in a document accompanying the product his name or business name or trade mark, as the case may be, and the address for delivery. The delivery address shall be the address of the place at which the manufacturer can actually be contacted.
(6) The manufacturer shall ensure that each product is accompanied by a copy of the EU declaration of conformity or certificate of conformity. In cases where more than one end-user is supplied at the same time, the full dose or consignment may be provided with a single copy of this document. The manufacturer shall also ensure that the product is accompanied by clear and comprehensible instructions and safety information in the Czech language.
(7) The manufacturer shall, in order to protect the health and safety of end-users, carry out tests on samples of products made available on the market and other necessary investigations where necessary in view of the risks posed by the product. These tests and investigations shall be carried out to the extent necessary to confirm or eliminate the risk posed by the product in relation to the manufacturer's intended purpose of use. The manufacturer shall keep records of complaints, non-compliant products and products withdrawn and shall keep distributors informed.
Authorised representative
The authorised representative shall keep the EU declaration of conformity or certificate of conformity and the technical documentation at the disposal of the supervisory authority for 10 years after the product has been placed on the market.
Importer
(1) Before placing the product on the market, the importer shall ensure that the manufacturer has carried out the conformity assessment procedure referred to in Section 10, has drawn up a technical dossier, where appropriate bearing the CE marking, that it is accompanied by an EU declaration of conformity or certificate of conformity and the required documents and that the manufacturer complies with the requirements set out in Sections 5 (4) and 5.
(2) The importer shall ensure that the product is accompanied by instructions and safety information in the Czech language.
(3) The importer shall, for a period of 10 years from the placing on the market of the product, keep a copy of the EU declaration of conformity or certificate of conformity at the disposal of the supervisory authority and ensure that the technical documentation is submitted to the supervisory authority at its request.
(4) The importer shall indicate on the product, in a language understood by the end-users and the supervisory authority, or, if this is not possible, on the packaging or in a document accompanying the product his name or business name or trade mark, as the case may be, and the address for service.
(5) The importer shall, in order to protect the health and safety of end-users, carry out tests on samples of products made available on the market and other necessary investigations where necessary in view of the risks posed by the product. These tests and investigations shall be carried out to the extent necessary to confirm or eliminate the risk posed by the product in relation to the manufacturer's intended purpose of use. The importer shall keep records of complaints, non-compliant products and products withdrawn and shall keep distributors informed.
Distributor
The distributor shall verify that:
(a) the product bears the CE marking if required;
(b) the product is accompanied by an EU declaration of conformity or a certificate of conformity and the required documents and instructions and safety information in the Czech language; and
(c) the manufacturers and importers have complied with the requirements laid down in Articles 5 (4) and (5) and 7 (4).
Time for identification of operator
The operator shall keep for a period of 10 years after the product has been placed on the market the data by which, at the request of the supervisory authority, the operator who supplied the product to him or to whom the product has been delivered.
Conformity assessment procedures
(1) The following procedures shall be used to assess the conformity of the equipment and, if necessary, the instruments referred to in Article 1 (2) (b):
(a) for the installation groups I and II, categories M 1 and 1, the EU-type examination procedure (Module B) set out in Annex 3 to this Regulation in conjunction with one of the following procedures:
1. conformity with the type based on the quality assurance of the production process (module D) set out in Annex 4 to this Regulation; or
2. conformity with the product verification type (Module F) set out in Annex 5 to this Regulation,
(b) for groups of installations I and II, categories M 2 and 2:
1. for combustion engines and electrical equipment of the following groups and categories, the EU-type examination procedure (Module B) set out in Annex 3 to this Regulation in conjunction with one of the following procedures:
1.1. Conformity to type based on internal control of production and testing of products under supervision (Module C1) as set out in Annex 6 to this Regulation; or
1.2. Compliance with the product quality assurance type (module E) set out in Annex 7 to this Regulation,
2. for other installations of these groups and categories of internal production control (module A) set out in Annex 8 to this Regulation and the transmission of the technical documentation set out in point 2 of Annex 8 to this Regulation to a notified body which shall confirm its receipt without undue delay and retain the documentation,
(c) for the installation group II, category 3, internal production control (module A) set out in Annex 8 to this Regulation;
(d) in addition to the procedures referred to in points (a), (b) or (c), conformity based on the verification of each product (Module G) set out in Annex 9 to this Regulation may also be used for the groups of devices I and II.
(2) For protection systems, the procedure referred to in paragraph 1 (a) or (d) shall apply.
(3) The procedures referred to in paragraph 1 shall also apply to components, except for the location of the CE marking and the drawing up of the EU declaration of conformity. The manufacturer shall issue a written certificate of conformity declaring compliance of components with the requirements laid down in this Regulation and indicating their characteristics and the manner in which they must be incorporated into equipment or protective systems in order to meet the essential technical requirements applicable to completed equipment or protective systems.
(4) As regards safety aspects set out in point 1.2.7 of Annex 2 to this Regulation, the procedure set out in Annex 8 to this Regulation may also be used in addition to the conformity assessment procedures referred to in paragraphs 1 and 2.
(5) Documents and correspondence relating to the conformity assessment procedures referred to in paragraphs 1 to 4 shall be drawn up in the Czech language.
Presumption of conformity
(1) Where a product conforms to harmonised standards or parts thereof which relate to the product and 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 of it apply.
(2) In the absence of harmonised standards, the Office for Technical Standardisation, Metrology and National Testing (hereinafter referred to as "the Office ') shall publish in the Office Bulletin information on existing Czech technical standards and other documents which prescribe the technical requirements to be met by the product (hereinafter referred to as" the technical specifications') which are considered appropriate for the correct implementation of the essential technical requirements.
EU declaration of conformity
(1) The EU declaration of conformity confirms that compliance with the essential technical requirements has been demonstrated.
(2) The EU declaration of conformity shall be drawn up in accordance with the model set out in Annex 10 to this Regulation, shall contain the elements set out in the conformity assessment procedures set out in Annexes 3 to 9 to this Regulation and shall be kept up to date. The EU declaration of conformity shall be translated into the language (s) required by the Member State of the European Union in which the product is placed or made available on the market.
(3) Where a product 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, 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.
Position of CE marking, identification numbers of notified bodies and other markings
(1) The CE marking to be placed before the product is placed on the market shall be placed on the product or its production label. Where this is not possible or justified due to the nature of the product, the CE marking shall be placed on the packaging and accompanying documents.
(2) The notified body's identification number, which participated in the conformity assessment with the type based on process quality assurance set out in Annex 4 to this Regulation (Module D), conformity assessment with product verification type set out in Annex 5 to this Regulation (Module F), conformity assessment with the type based on product quality assurance set out in Annex 7 to this Regulation (Module E) or conformity assessment based on verification of each individual product set out in Annex 9 to this Regulation (Module G), shall be attached to the CE marking by the notified body or, under its instructions, by the manufacturer or his authorised representative.
(3) The CE marking and, where appropriate, the identification number of the notified body shall be followed by the special explosion protection marking, the group and category of equipment marks and, where appropriate, the additional marking and data set out in point 1.0.5 of Annex 2 to this Regulation.
(4) The CE marking and the markings, marks and particulars referred to in paragraph 3 and, where appropriate, the identification number of the notified body may be affixed to any other mark indicating a specific risk or use.
(5) Products which are designed for a particular explosive environment must be labelled accordingly.
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 laying down requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339 / 93, Article 15 of the Law or Article 13 (1);
(b) the CE marking, if required, has not been affixed;
(c) the special bomb protection marking, the group and category of equipment marks and other markings and the data have been placed in contravention of point 1.0.5 of Annex 2 to this Regulation or have not been affixed;
(d) the identification number of the notified body has been located in contravention of Paragraph 13 or has not been located;
(e) the product is not accompanied by an EU declaration of conformity or, where appropriate, a certificate of conformity;
(f) the EU declaration of conformity or, where appropriate, the certificate of conformity has not been drawn up in accordance with this Regulation;
(g) the technical documentation is missing or incomplete;
(h) the information referred to in § 5 (5) or § 7 (4) is missing or incorrect or incomplete; or
(i) the other administrative requirement laid down in § 6 of the Act or § 8 of the Act or § 5 or § 7 has not been met.
Transitional provisions
(1) Products complying with the requirements laid down by Government Decree No. 23 / 2003 Coll., laying down technical requirements for equipment and protective systems intended for use in potentially explosive atmospheres may continue to be made available on the market and put into service if they were placed on the market before the date of entry into force of this Regulation.
(2) Valid certificates and other documents which certify the facts established and which were issued by notified persons under Government Regulation No. 23 / 2003 Coll., remain valid and are considered as certificates and other documents under this Regulation.
Repeal
Government Regulation No. 23 / 2003 Coll., laying down technical requirements for equipment and protective systems intended for use in potentially explosive atmospheres, is repealed.
Efficacy
This Regulation shall enter into force on 20 April 2016.
Prime Minister:
Sobotka v. r.
Minister for Industry and Trade:
Ing. Mládek, CSc., v. r.
Příloha č. 1
Annex No 1 to Government Regulation No 116 / 2016 Coll.
CRITERIA FOR ESTABLISHMENT OF GROUPS OF CATEGORIES
1. Device group I
(a) The category of M 1 equipment includes equipment designed and, where necessary, equipped with specific means of protection so that it is able to operate in accordance with the operating parameters specified by the manufacturer and ensures a very high level of protection.
The equipment of this category is intended for use in underground mines and in those surface installations of these mines which are threatened by mining gas or flammable dust.
The equipment of this category shall remain operational in an explosive environment even in the case of exceptional incidents involving the equipment, in particular, shall be equipped with means of protection such that:
1. in the event of failure of one of the means of protection, at least 1 additional independent means of protection has ensured the required level of protection; or
2. the required level of protection has been ensured even in the event of two mutually independent failures.
Equipment of this category shall comply with the additional requirements set out in point 2.0.1 of Annex 2 to this Regulation.
(b) The category of M 2 equipment includes devices designed to be capable of operation in accordance with the operating parameters specified by the manufacturer and providing a high level of protection.
The equipment of this category is intended for use in underground mines and in those surface installations of these mines which may be threatened by mining gas or flammable dust.
These devices shall be switched off from the grid in the event of an explosive environment.
The means of protection relating to equipment of this category shall ensure the required level of protection in normal operation, even in the case of more severe operating conditions resulting in particularly inefficient handling and environmental changes.
The equipment of this category shall meet the additional requirements set out in point 2.0.2 of Annex 2.
2. Equipment Group II
(a) Equipment category 1 shall include equipment designed to be capable of operating in accordance with the operating parameters specified by the manufacturer and providing a very high level of protection.
Equipment of this category shall be designed for use in areas in which it is permanently, for long periods or often explosive environments generated by gases, vapour or fog or dust air mixtures.
The equipment of this category shall ensure the required level of protection even in the case of exceptional events involving the equipment, in particular by such means of protection that:
1. in the event of failure of one of the means of protection, at least 1 additional independent means of protection has ensured the required level of protection; or
2. the required level of protection has been ensured even in the event of two mutually independent failures.
Equipment of this category shall comply with the additional requirements set out in point 2.1 of Annex 2 to this Regulation.
(b) Equipment category 2 shall include equipment designed to be capable of operation in accordance with the operating parameters specified by the manufacturer and providing a high level of protection.
Equipment of this category shall be designed for use in spaces where occasional explosive atmospheres generated by gases, vapour, fog or dust air mixtures are likely to occur.
The protection devices related to equipment of this category shall ensure the required level of protection even in the case of frequently emerging failures or failures of equipment that are normally to be expected.
Equipment of this category shall comply with the additional requirements set out in point 2.2 of Annex 2 to this Regulation.
(c) Equipment category 3 shall include equipment designed to be capable of operation in accordance with the operating parameters specified by the manufacturer and to ensure a normal level of protection.
Equipment of this category is intended to be used in areas where the explosive environment generated by gases, vapour, fog or dust air mixtures is unlikely to occur and, if an explosive environment occurs, it is likely to occur only rarely and only for a short time.
Equipment of this category ensures the required level of safety in normal operation.
Equipment of this category shall comply with the additional requirements set out in point 2.3 of Annex 2 to this Regulation.
Příloha č. 2
Annex No 2 to Government Regulation No 116 / 2016 Coll.
ESSENTIAL REQUIREMENTS FOR HEALTH AND SAFETY PROTECTION RELATING TO THE PROPOSAL AND CONSTRUCTION OF EQUIPMENT AND PROTECTION SYSTEMS INTENDED FOR USE IN INSTALLATIONS WITH NON-EXPLOSION
Preliminary remarks
A. Account must be taken of and used immediately for technological knowledge.
B. The instruments referred to in Article 1 (2) (b) shall be subject to the essential health and safety requirements only to the extent that they are necessary for their safe and reliable operation and operation in view of the risk of explosion.
1. Common requirements for equipment and protective systems
1.0 General requirements
1.0.1 Principles of complex explosion safety
Equipment and protective systems intended for use in potentially explosive atmospheres shall be designed with regard to complex explosion safety.
The manufacturer shall therefore take measures to:
(a) prevent, where possible, the creation of an explosive environment which could arise in or spread from the facilities or protective systems themselves;
(b) prevent ignition of the explosive environment, taking into account the characteristics of all electrical and non-electrical sources of ignition;
(c) the explosion is immediately suppressed or the extent of the effect of explosion flames and explosion pressure is limited to a sufficient level of safety if, however, an explosion may occur which could directly or indirectly endanger persons and, where appropriate, domestic animals or property.
1.0.2 Equipment and protective systems shall be designed and manufactured after appropriate analysis of possible operational failures so as to avoid dangerous situations as far as possible.
Any reasonably foreseeable misuse shall be taken into account.
1.0.3 Special conditions for control and maintenance
Equipment and protective systems subject to special control and maintenance conditions shall be designed and constructed taking into account these conditions.
1.0.4 Environmental conditions
Equipment and protective systems shall be designed and constructed in such a way as to be able to withstand actual or foreseeable environmental conditions.
1.0.5. Markings
The equipment and protective systems shall bear at least the following particulars in a legible and indelible manner:
(a) the name, business name or trade mark and address of the manufacturer;
(b) CE marking (see Annex II to Regulation (EC) No 765 / 2008),
(c) identification of the series or type;
(d) the batch number or serial number, if any;
(e) the year of manufacture;
(f) the special explosive protection marking followed by the group and category of equipment mark;
(g) for equipment group II, the letter "G" (for explosive atmospheres generated by gases, vapour or fog); or
(h) the letter "D" (for dust generated explosive environments).
Furthermore, any information relevant to the safe use of equipment and protective systems shall be indicated on the equipment and protective systems, where appropriate.
1.0.6 Instructions for use
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Regulation Information
| Citation | Government Regulation No. 116 / 2016 Coll., on conformity assessment of equipment and protective systems intended for use in potentially explosive atmospheres when making them available on the market |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 18.04.2016 |
|---|---|
| Effective from | 20.04.2016 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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