Explosion Protection Directive 2015 - 2015 Exsv

Original Language Title: Explosionsschutzverordnung 2015 – ExSV 2015

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Regulation of the Federal Minister for Science, Research and the Economy on equipment and protective systems for the intended use in potentially explosive atmospheres (explosion protection ordinance 2015-ExSV 2015)

Because of

1.

§ 2 (1) of the Machine-Marketing and Notifying G-MING, BGBl. I No 77/2015, and

2.

§ 181 of the MinroG MinroG Act, BGBl. I n ° 38/1999, as last amended by the Federal Law BGBl. I No 80/2015, and

3.

§ 3 (4) and (6), Section 7 (1), (5) and (6) and Section 7b (7) of the Electrotechnic Act 1992-ETG 1992, BGBl. N ° 106/1993, as last amended by the Federal Law BGBl. I No 129/2015,

Is prescribed:

table of contents

Section 1
General provisions

§ 1.

Scope

§ 2.

Implementation

§ 3.

Definitions

§ 4.

Provision on the market and commissioning

§ 5.

Essential health and safety requirements

§ 6.

Free movement

Section 2
Duties of economic operators

§ 7.

Obligations of producers

§ 8.

Plenipotentiaries

§ 9.

Obligations of the importer

§ 10.

Obligations of traders

§ 11.

Circumstances under which the manufacturer ' s obligations shall also apply to importer and trader

§ 12.

Identification of economic operators

Section 3
Product compliance

§ 13.

Presumption of conformity of products

§ 14.

Conformity assessment procedures

§ 15.

EU Declaration of Conformity

§ 16.

General principles of the CE marking

§ 17.

Rules and conditions governing the affixing of the CE marking

Section 4
Conformity assessment

§ 18.

Notification of conformity assessment bodies, information requirements of the notifying authority

§ 19.

Requirements for notified bodies

§ 20.

Presumption of conformity in notified bodies

§ 21.

Branch companies of notified bodies and subcontracting

§ 22.

Notification procedure

§ 23.

Amendment of the notification

§ 24.

Challenge to the competence of notified bodies

§ 25.

Obligations of notified bodies in relation to their work

§ 26.

Reporting requirements of notified bodies

§ 27.

Coordination of notified bodies

Section 5
Supervision of the Union market, control of products imported into the Union market, protection of small-goods vehicles

§ 28.

Supervision of the Union market and control of products entering the Union market

§ 29.

Procedures for the treatment of products with which a risk is associated

§ 30.

Conformable products posing a risk

§ 31.

Formal non-compliance

6.
Transitional and final provisions

§ 32.

Transitional provisions

§ 33.

entry into force

§ 34.

Linguistic equality

ANNEX I

Decision criteria for the classification of equipment groups in categories

ANNEX II

Essential health and safety requirements for the design and construction of equipment and protective systems intended for use in potentially explosive atmospheres

ANNEX III

Module B: EU type-examination

ANNEX IV

Module D: Conformity with the design on the basis of a quality assurance related to the production process

ANNEX V

Module F: Conformity with the design on the basis of a product test

ANNEX VI

Module C1: Conformance with the design on the basis of an internal production control with monitored product tests

ANNEX VII

Module E: Conformity with the design on the basis of quality assurance based on the product

ANNEX VIII

Module A: Internal Manufacturing Control

ANNEX IX

Module G: Conformity based on a single test

ANNEX X

EU Declaration of Conformity (NR. xxxx)

Section 1

General provisions

Scope

§ 1. (1) This Regulation shall apply to the following devices and protective systems, hereinafter also referred to as "products":

1.

equipment and protective systems intended for use in potentially explosive atmospheres;

2.

Safety, control and control devices for use outside potentially explosive atmospheres, which are, however, necessary or contribute to the safe operation of equipment and protective systems in view of the explosion risks;

3.

Components intended for installation in the devices and protective systems referred to in Z 1.

(2) This Regulation shall not apply to:

1.

medical equipment intended for use in medical fields;

2.

equipment and protective systems in which the risk of explosion is caused solely by the presence of explosives or chemically unstable substances;

3.

equipment intended for use in domestic and non-commercial environments, in which an explosive atmosphere can be formed only rarely and only as a result of an unintended fuel outlet;

4.

personal protective equipment within the meaning of Directive 89 /686/EEC on the approximation of the laws of the Member States relating to personal protective equipment, OJ L 206, 22.7.1989, p. No. OJ L 399, 30.12.1989, p. 18, as last amended by Regulation (EU) No 1025/2012, OJ L 327, 31.12.2012, p. No. OJ L 316, 14.11.2012 S 12;

5.

seagoing ships and movable off-shore installations and equipment on board such vessels or installations;

6.

Means of transport, i.e. vehicles and associated trailers intended exclusively for the carriage of persons in the air, on road and rail networks or on the waterway, and means of transport, insofar as they are intended for the transport of: Goods in the air, on public road and rail networks or on the waterway are designed. Vehicles to be used in potentially explosive atmospheres shall not be excluded from the scope of this Regulation;

7.

Products within the meaning of Art. 346 (1) (lit). (b) of the Treaty on the Functioning of the European Union, BGBl III No 86/1999, as amended by BGBl III No 314/2013.

Implementation

§ 2. This Regulation will introduce Directive 2014 /34/EU on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres, OJ L 206, 22.7.2014, p. No. OJ L 96, 29.3.2014 p. 309, transposed into Austrian law.

Definitions

§ 3. For the purposes of this Regulation, the term:

1.

"equipment" means machinery, equipment, stationary or mobile devices, control and equipment components and warning and prevention systems which, individually or in combination, are used for the production, transmission, storage, measurement, control and conversion of equipment are intended for use in energy and/or for processing of materials and have their own potential sources of ignition and can thus cause an explosion;

2.

"protective systems" means any device other than the components of equipment which are intended to immediately stop and/or limit the explosion of explosions affected by an explosion and which are separately provided on the market as autonomous systems; ,

3.

"components" means those components which are necessary for the safe operation of equipment and protective systems without, however, having to perform an autonomous function;

4.

"explosive atmosphere" means a mixture of air and combustible gases, vapours, mists or dusts under atmospheric conditions, in which the combustion process, after ignition has occurred, transfers to the whole unburned mixture;

5.

"explosive area" means an area in which the atmosphere can be explosive due to local and operational conditions;

6.

"equipment group I" means equipment intended for use in underground mines and their installations which may be endangered by pit gas and/or combustible dusts; this includes the categories of equipment M1 referred to in Annex I; and M2;

7.

"equipment group II" means equipment intended for use in other areas which may be endangered by an explosive atmosphere, including the categories 1, 2 and 3 of Annex I;

8.

"equipment category" means the classification of equipment within each group of equipment in accordance with Annex I, which provides the necessary level of assurance that it is necessary to ensure that:

9.

"intended use" means the use of a product in a manner prescribed by the manufacturer by assigning the device to a particular device group and category or by making all the information necessary for the safe operation of the product; of the protection system, of the equipment or of the component;

10.

"making available on the market" means any supply of a product for distribution, consumption or use on the Union market in the course of a business activity, whether in return for payment or free of charge;

11.

"placing on the market" means the first-time provision of a product on the Union market;

12.

"manufacturer" means any natural or legal person who produces a product or develop or manufacture and market this product under their own name or trademark or use it for their own purposes;

13.

"authorised representative" means any natural or legal person established in the European Union who has been instructed in writing by a manufacturer to carry out certain tasks on his behalf;

14.

"importer" means any natural or legal person established in the European Union who places a product on the market in the Union market from a third country;

15.

"trader" means any natural or legal person in the supply chain who provides a product on the market, with the exception of the manufacturer or the importer;

16.

"economic operators" means the manufacturer, the authorised representative, the importer and the trader;

17.

"technical specification" means a document in which the technical requirements which a product must meet are required;

18.

Harmonised standard " means a harmonised standard as defined in Article 2 (1) (lit). c of Regulation (EU) No 1025/2012 on European Standardisation, amending Directives 89 /686/EEC and 93 /15/EEC and Directives 94 /9/EC, 94 /25/EC, 95 /16/EC, 97 /23/EC, 98 /34/EC, 2004 /22/EC, 2007 /23/EC, 2009 /23/EC and 2009 /105/EC and Repeal of Decision 87 /95/EEC and Decision No 1673 /2006/EC, OJ L 136, 31.5.2002, p. No. OJ L 316, 14.11.2012 p.12;

19.

"conformity assessment" means the procedure for assessing whether the essential health and safety requirements have been met by this Regulation to a product;

20.

"conformity assessment body" means a body carrying out conformity assessment activities, including calibrations, tests, certifications and inspections;

21.

"recall" means any measure intended to effect the return of an electrical operating means already provided to the end user;

22.

"withdrawal" means any measure intended to prevent a product in the supply chain from being made available on the market;

23.

"Union harmonisation legislation" means the legislation of the European Union on the harmonisation of the conditions for the marketing of products;

24.

"CE marking" means the marking by which the manufacturer declares that the product satisfies the applicable requirements laid down in the European Union's harmonisation legislation on its affixing;

25.

"Market Surveillance Authority" means a competent authority in accordance with § 6 (1) MING, § 13 ETG 1992 or § § 170, 171 MinroG for the implementation of market surveillance;

Provision on the market and commissioning

§ 4. (1) Products may only be made available on the market and put into service if they are in accordance with appropriate installation and maintenance and in accordance with the intended use of this Regulation.

This Regulation shall not affect the requirements laid down for the protection of persons, and in particular of workers, in the use of the products concerned, provided that these do not make any changes to these products in relation to the provisions of this Regulation.

(3) It is permissible that, in particular in the case of fairs, exhibitions and presentations of this Regulation, products which do not comply with this Regulation should not be issued, provided that a visible sign clearly indicates that such products do not meet the requirements of: and shall not be acquired until the manufacturer has established conformity with the provisions of this Regulation. In the case of presentations, the appropriate security measures shall be taken to ensure the protection of persons.

Essential health and safety requirements

§ 5. Products must comply with the essential health and safety requirements set out in Annex II, which shall be applicable to them, taking into account their intended use.

Free movement

§ 6. The provision on the market and the putting into service of products which comply with the provisions of this Regulation shall not be prohibited, restricted or impeded.

Section 2

Duties of economic operators

Obligations of producers

§ 7. (1) Manufacturers, when placing their products on the market or using them for their own purposes, must ensure that they have been designed and manufactured in accordance with the essential health and safety requirements set out in Annex II.

Manufacturers shall draw up the technical documentation in accordance with Annexes III to IX and have the conformity assessment procedure in question carried out or carried out in accordance with § 14.

1.

If it has been demonstrated by this procedure that the product which is not a component meets the applicable requirements, manufacturers shall draw up an EU declaration of conformity and shall affix the CE marking to the product.

2.

If the relevant conformity assessment procedure has shown that a component complies with the applicable requirements, manufacturers shall issue a written certificate of conformity in accordance with Section 14 (3).

Manufacturers shall ensure that each product has a copy of the EU declaration of conformity, or the certificate of conformity is attached. However, if a large number of products are delivered to one and the same user, the batch or delivery concerned may be accompanied by a single copy.

(3) Manufacturers must keep the technical documentation and the EU declaration of conformity or, where appropriate, the certificate of conformity for a period of ten years from the placing on the market of the product.

(4) Manufacturers must:

1.

ensure conformity with this Regulation in the case of series production, by means of appropriate procedures. changes to the design of the product or its characteristics, as well as changes in the harmonised standards or other technical specifications referred to in the declaration of conformity of a product, must be duly taken into consideration;

2.

if this is considered appropriate in the light of the risks posed by a product, to carry out sample checks on the products made available on the market in order to protect the health and safety of consumers, and if necessary, keep a list of complaints concerning non-conformist products and recalls of products and keep distributors informed of such monitoring.

(5) Manufacturers must ensure that products which have placed them on the market carry a type, batch or serial number or a different identification mark for their identification, or, if this is not due to the size or nature of the product, it is possible to provide the necessary information on the packaging or in the documents attached to the product.

(6) Manufacturers must ensure that products which they have placed on the market and are not components with the special explosion protection mark and, where appropriate, the other markings and information referred to in Annex II, Z 1.0.5.

(7) Manufacturers must have their name, company or registered trade mark and their postal address under which they can be reached, either on the product itself or, if this is not possible, on the packaging or in the Specify the product attached to the product. The address refers to a one-stop shop, under which the manufacturer can be reached. The contact details are to be stated in German.

(8) Manufacturers must ensure that the product is accompanied by the operating instructions and the safety information in the German language. These operating instructions and information, as well as all markings, must be clear, comprehensible and clear.

(9) Manufacturers who consider or have reason to believe that a product they have placed on the market is not in conformity with this Regulation shall immediately take the necessary corrective measures to ensure the conformity of this Directive with the To produce a product or to withdraw it or recall it. In addition, where risks are associated with the product, manufacturers must immediately inform the market surveillance authorities of the Member States of the European Union where they have provided the product on the market, and where detailed information is provided, in particular on non-compliance and the corrective measures taken.

(10) Manufacturers shall, at the request of the market surveillance authority, have all the information and documents necessary to demonstrate the conformity of the product with this Regulation, in paper form or by electronic means, on the basis of the reasoned request. in German. They shall cooperate with this authority, at their request, in all measures to prevent risks associated with electrical equipment which they have placed on the market.

Plenipotentiaries

§ 8. (1) A manufacturer may designate an authorised representative in writing. The obligations pursuant to Section 7 (1) and the obligation to draw up the technical documentation referred to in § 7 (2) are not part of the mandate of an authorised representative.

(2) An authorised representative shall carry out the tasks laid down by the manufacturer, which shall be laid down on behalf of the manufacturer. The contract shall allow the authorised representative to carry out at least the following tasks:

1.

keeping the EU declaration of conformity or, where appropriate, the certificate of conformity and the technical documentation available to the market surveillance authority for a period of 10 years after the product has been placed on the market;

2.

on the basis of a reasoned request from a market surveillance authority or a national authority responsible for the control of external borders, providing all the information and documentation necessary to demonstrate the conformity of a product to the latter, Authority;

3.

, at the request of the Market Surveillance Authority, cooperation in any measure to avert the risks associated with products belonging to the authorised representative's duties.

Obligations of the importer

§ 9. (1) The importer may place only conformable products on the market.

(2) Before placing a product on the market, the importer must ensure that the conformity assessment procedure in question has been carried out by the manufacturer in accordance with Section 14. They shall ensure that the manufacturer has produced the technical documentation, that the product is marked with the CE marking and is accompanied by the EU declaration of conformity or the certificate of conformity as well as the necessary documents , and that the manufacturer has fulfilled the requirements of § 7 (5), (6) and (7).

Where a importer considers or has reason to believe that a product does not comply with the essential health and safety requirements of Annex II, he may not place this product on the market before conformity of the product. In addition, if a risk is associated with the product, the importer shall inform the manufacturer and the market surveillance authority thereof.

(3) The importer shall have on the product itself its name, company or registered trade mark and its postal address where it can be contacted or, if not possible, on the packaging or in the product accompanying documents. The contact details are to be stated in German.

(4) The importer must ensure that the product is accompanied by the operating instructions and the safety information in the German language.

(5) As long as a product is in its own responsibility, the importer must ensure that the conditions of its storage or transport comply with the product's conformity with the essential health and safety requirements of Annex II shall not be affected.

(6) In the event that this is considered appropriate in the light of the risks posed by a product, the importer shall carry out sample checks on products made available on the market in order to protect the health and safety of end-users, examine complaints and, if necessary, keep a list of complaints, non-compliant products and product recalls, and keep distributors informed of such monitoring.

(7) A importer who considers or has reason to believe that a product which they have placed on the market is not in conformity with this Regulation shall immediately take the necessary corrective measures to ensure the conformity of that product with the To produce a product or to withdraw it or recall it. In addition, where risks are associated with the product, the importer shall forthwith inform the market surveillance authorities of the Member States of the European Union in which they have provided the product on the market, and shall make it possible to: detailed information, in particular on the non-compliance and the corrective measures taken.

(8) The importer shall, after placing the product on the market, have a copy of the EU declaration of conformity or, where appropriate, the certificate of conformity for the market surveillance authority for ten years, and shall ensure that they are to submit the technical documentation on request.

(9) The importer must, at the request of the market surveillance authority, all the information and documents required for the verification of the conformity of the product in the form of a paper or by electronic means in the German language shall be made available. They must cooperate with this authority, at their request, in all measures to avert the risks associated with products which have placed them on the market.

Obligations of traders

§ 10. (1) distributors shall take due diligence into the requirements of this Regulation when they provide a product on the market.

(2) Before providing a product on the market, dealers must verify that the product is marked with the CE marking, where necessary, and that the EU declaration of conformity or the certificate of conformity and the necessary The documents and the instructions for operating and the safety information in German are attached, and whether the manufacturer and the importer have complied with the requirements laid down in Article 7 (5), (6) and (7) and Article 9 (3). Where a trader considers or has reason to believe that a product does not comply with the essential health and safety requirements set out in Annex II, it may not provide that product on the market before the Product conformity is manufactured. In addition, if a risk is associated with the products, the trader must also inform the manufacturer or importer and the market surveillance authority.

(3) As long as a product is in its responsibility, distributors must ensure that the conditions of its storage or transport comply with the product's compliance with the essential health and safety requirements of Annex II.

(4) traders who are of the opinion or have reason to believe that a product they are provided on the market does not comply with this Regulation must ensure that the necessary corrective measures are taken to ensure that: To make this product conformity or to withdraw it or recall it if necessary. In addition, if risks are associated with the product, dealers must immediately inform the market surveillance authorities of the Member States of the European Union where they have provided the product on the market, and in doing so, detailed information, in particular on the non-compliance and the corrective measures taken.

(5) traders must provide the market surveillance authority with all the information and documents required for the verification of the conformity of a product, either in paper form or by electronic means, on the basis of their reasoned request. They must cooperate with this authority, at their request, in all measures to avert the risks associated with products that they have made available on the market.

Circumstances under which the manufacturer ' s obligations shall also apply to importer and trader

§ 11. A importer or trader shall be deemed to be a producer for the purposes of this Regulation and shall be subject to the obligations of a manufacturer in accordance with § 7 if he places a product on the market under his or her own name or trademark or is already in product on the market so as to be able to affect conformity with this Regulation.

Identification of economic operators

§ 12. (1) The economic operators shall, at the request of the market surveillance authority, be required to name the economic operators,

1.

from which they have obtained a product;

2.

to which they have delivered a product.

(2) The economic operators must be able to provide the information referred to in paragraph 1 10 years after the product has been referred to, and 10 years after the product has been handed over.

Section 3

Product compliance

Presumption of conformity of products

§ 13. (1) In the case of products which are in conformity with harmonised standards or parts of which the references have been published in the Official Journal of the European Union, conformity with the essential health and safety requirements shall be in accordance with Annex II, which are covered by the relevant standards or parts thereof.

(2) Where there are no harmonized standards, the Federal Minister for Science, Research and the Economy shall take the necessary measures to ensure that the persons concerned meet the existing national standards and technical specifications. They shall be considered as important or helpful for the proper implementation of the essential health and safety requirements set out in Annex II.

Conformity assessment procedures

§ 14. (1) The conformity assessment procedures shall be carried out for equipment and, if necessary, devices pursuant to § 1 (1) (2) (2) as follows:

1.

For the equipment groups I and II, category M 1 and 1, the EU type-examination shall be applied in accordance with Annex III, in conjunction with one of the following:

a)

Conformity with the design on the basis of a quality assurance related to the production process referred to in Annex IV or

b)

conformity with the design on the basis of an examination of the products referred to in Annex V;

2.

for device groups I and II, equipment category M 2 and 2:

a)

for engines with internal combustion and for electrical equipment of these groups and categories, the EU type-examination in accordance with Annex III shall apply, in conjunction with one of the following:

aa)

conformity with the design on the basis of internal production control with monitored product tests in accordance with Annex VI,

bb)

conformity with the design on the basis of quality assurance in relation to the product referred to in Annex VII,

b)

the other equipment of these groups and categories shall be subject to the internal production control referred to in Annex VIII, and the technical documentation referred to in Annex VIII (2) shall be sent to a notified body responsible for obtaining such documents immediately confirmed and kept it;

3.

for device group II, equipment category 3, the internal production control referred to in Annex VIII shall apply;

4.

for groups of equipment I and II: In addition to the procedures referred to in Z 1, 2 and 3 of this paragraph, conformity may also be applied on the basis of an individual test in accordance with Annex IX.

(2) For protection systems, conformity assessment shall be carried out in accordance with the procedure referred to in paragraph 1 (1) (1) or (4).

(3) The procedures referred to in paragraph 1 shall apply to components other than the affixing of the CE marking and the issue of the EU declaration of conformity. The manufacturer must issue a written certificate of conformity which explains the conformity of the components with the applicable provisions of this Regulation and the characteristics of these components and the conditions for shall be installed in equipment and protective systems which contribute to the fulfilment of the essential health and safety requirements applicable to finished equipment and protective systems in accordance with Annex II.

(4) In addition to the conformity assessment procedures referred to in paragraphs 1 and 2, the procedure referred to in Annex VIII may also be applied in respect of the safety aspects referred to in Annex II, Z 1.2.7.

(5) By way of derogation from (1), (2) and (4), the market surveillance authority may, on a duly substantiated request, authorise the placing on the market and putting into service of products which are not components on the domestic market, to which the products referred to in paragraphs 1, 2 and 4 and the use of which is in the interests of protection.

(6) The documents and the correspondence relating to the conformity assessment procedures referred to in paragraphs 1 to 4 shall be drawn up in German.

EU Declaration of Conformity

§ 15. (1) The EU declaration of conformity states that compliance with the essential health and safety requirements set out in Annex II has been demonstrated.

(2) The EU declaration of conformity corresponds in its construction to the specimen in Annex X, contains the elements indicated in the relevant conformity assessment procedures of Annexes III to IX and must be kept up to date. It is to be translated into German for products which are placed on the market or are made available on the market in Germany.

(3) A product of a number of European Union legislation, each requiring an EU declaration of conformity, is to issue only a single EU declaration of conformity for all EU legislation. This declaration shall specify the relevant legislation of the European Union together with its reference in the Official Journal.

(4) By issuing the EU declaration of conformity, the manufacturer shall take full responsibility for ensuring that the product complies with the requirements of this Regulation.

General principles of the CE marking

§ 16. The CE marking shall be subject to the general principles laid down in Article 30 of Regulation (EC) No 765/2008 concerning the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EC) No 765/2008. (EEC) No 339/93, OJ L 339, 31.12.1993 OJ L 218, 13.8.2008 p.30.

Rules and conditions governing the affixing of the CE marking

§ 17. (1) The CE marking shall be affixed legibly, legibly and permanently to the product or its data plaque. If the nature of the product does not permit or does not justify it, it shall be affixed to the packaging and to the accompanying documents.

(2) The CE marking shall be affixed prior to placing the product on the market.

(3) Behind the CE marking, the identification number of the notified body shall be the notified body, if that body has been involved in the production control phase. The identification number of the notified body shall be affixed either by the body itself or by its instructions by the manufacturer or his authorised representative.

(4) Behind the CE marking and, where applicable, the identification number of the notified body, the specific explosion protection mark shall be , the marks referring to the category and category of equipment and, where appropriate, the other markings and information referred to in Annex II, Z 1.0.5.

(5) Behind the CE marking and the markings, markings and information referred to in paragraph 4 and, where applicable, the identification number of the notified body, a different character may be present, which may be of particular risk or use . Products which are designed for a certain explosive atmosphere must be labelled accordingly.

(6) The market surveillance authority must ensure that the system of CE marking is properly implemented and that, in the event of misuse of this marking, steps within the meaning of § 9m ETG 1992 .

Section 4

Conformity assessment

Notification of conformity assessment bodies, information requirements of the notifying authority

§ 18. (1) The Federal Minister for Science, Research and the Economy shall notify the European Commission and the other Member States of the European Union of the bodies empowered to carry out conformity assessment tasks as independent third parties in accordance with of this Regulation.

(2) The Federal Minister for Science, Research and the Economy has informed the European Commission of its procedures for the evaluation and notification of conformity assessment bodies and for the monitoring of notified bodies, as well as the relevant information on the Changes to be notified.

Requirements for notified bodies

§ 19. (1) A conformity assessment body shall comply with the requirements of para. 2 to 11 for the purposes of the notification.

(2) A conformity assessment body must have been established in accordance with Austrian law and must have legal personality.

(3) A conformity assessment body shall be an independent third party with the establishment or product, the or the product, the that he assesses, is not in any connection whatsoever. A body belonging to a trade association or association and assesses the products in whose design, manufacture, supply, assembly, use or maintenance are parties to undertakings represented by that association, may be considered as such under the condition that their independence and the absence of any conflicts of interest are demonstrated.

(4) A conformity assessment body, its top management level and the staff responsible for the performance of conformity assessment tasks may not design, manufacturer, supplier, installer, buyer, owner, user, or The maintenance of the products to be evaluated or the representative of one of these parties. This does not preclude the use of products already subject to conformity assessment, which are necessary for the activities of the conformity assessment body, or the use of such products for personal use. A conformity assessment body, its top management level and the staff responsible for the performance of conformity assessment tasks may not be directly involved in the design, manufacture or The construction, marketing, installation, use or maintenance of these products will also be involved in the parties involved in these activities. They shall not deal with activities which could affect their independence in the assessment or their integrity in relation to the conformity assessment measures for which they are notified. This is especially true for consulting services.

A conformity assessment body shall ensure that the activities of its subsidiary undertakings or subcontractors do not adversely affect the confidentiality, objectivity and impartiality of their conformity assessment activities.

(5) The conformity assessment body and its staff shall carry out the conformity assessment activities with the greatest possible professionalism and professional competence in the field in question; they shall not be allowed to: influence, in particular financial, which may affect its assessment or the results of its conformity assessment work, and which, in particular, emanates from persons or groups of persons who are interested in the outcome of the outcome of the of these activities.

(6) A conformity assessment body must be in a position to perform all conformity assessment tasks which it is entitled to, in accordance with Annexes III to VII and Annex IX and for which it has been notified, whether those tasks are carried out by the Body itself, on its behalf or under its responsibility are fulfilled.

A conformity assessment body shall have at all times, in each conformity assessment procedure and in respect of each type and category of products for which it has been notified, that:

1.

the necessary staff, with expertise and sufficient experience, to carry out the tasks of conformity assessment;

2.

Descriptions of procedures according to which the conformity assessment is carried out in order to ensure the transparency and repeatability of these procedures; it must have adequate instruments and appropriate procedures in which: the tasks which it performs as notified body and other activities;

3.

Procedures for carrying out activities with due regard to the size of a company, the industry in which it operates, its structure, the degree of complexity of the product technology concerned and the fact that it is Production process is a mass production or series production.

A conformity assessment body must have the necessary means for the appropriate execution of the technical and administrative tasks associated with the conformity assessment and access to all necessary equipment, or Facilities.

(7) The staff responsible for carrying out the tasks involved in the conformity assessment shall have the following:

1.

sound professional and vocational training, covering all conformity assessment activities for which the conformity assessment body has been notified;

2.

adequate knowledge of the requirements to be met by the assessments to be carried out and the sufficient power to carry out such assessments;

3.

adequate knowledge and understanding of the essential health and safety requirements set out in Annex II, the harmonised standards applicable and the relevant provisions of the Union's harmonisation legislation and of the relevant provisions of the relevant national legislation and

4.

The ability to produce certificates, protocols and reports as proof of assessments carried out.

(8) The impartiality of the conformity assessment body, its top management level and the personnel responsible for conformity assessment activities must be guaranteed. The remuneration of the senior management level and the staff responsible for the performance of conformity assessment tasks shall not be based on the number of assessments carried out or the results of such assessments.

(9) The conformity assessment bodies shall take out liability insurance.

(10) Information obtained by the staff of a conformity assessment body in the performance of its tasks in accordance with Annexes III to VII and Annex IX or any of the relevant national implementing rules shall be covered by the professional secrecy, which, however, does not apply to the market surveillance authority and the Federal Minister for Science, Research and the Economy. Property rights must be protected.

(11) The conformity assessment bodies shall participate in the relevant standardisation activities and the activities of the coordination group of notified bodies set up under the Directive 2014 /34/EU, respectively. ensure that the staff responsible for carrying out the conformity assessment tasks are informed of the situation. The conformity assessment bodies shall apply the administrative decisions and documents drawn up by this group as a general guideline.

Presumption of conformity in notified bodies

§ 20. If a conformity assessment body proves that it meets the criteria of the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed that they shall: Requirements laid down in § 19 shall be complied with in so far as the harmonized standards applicable cover these requirements.

Branch companies of notified bodies and subcontracting

§ 21. (1) The notified body shall carry out or transfer to a sub-contractor certain tasks related to the conformity assessment, and shall ensure that the subcontractor or the branch undertaking has the following responsibilities: According to § 19, and to inform the Federal Minister for Science, Research and Economics accordingly.

(2) The notified bodies shall be fully responsible for the work carried out by subcontractors or branch undertakings, irrespective of where they are established.

(3) Work may only be awarded to a subcontractor or transferred to a subsidiary company if the customer agrees to it.

The notified bodies shall have the relevant documentation relating to the assessment of the qualifications of the subcontractor or of the branch undertaking and the work carried out by it in accordance with Annexes III to VII and Annex IX to the to the notifying authority.

Notification procedure

§ 22. (1) The Federal Minister for Science, Research and the Economy shall only notify conformity assessment bodies which meet the requirements of § 19.

(2) The notification shall include complete information on the conformity assessment activities, the conformity assessment modules concerned and the products, and the certificate of competence in question.

Amendment of the notification

§ 23. (1) If the Federal Minister for Science, Research and the Economy finds or is informed that a notified body no longer fulfils the requirements laid down in § 19 or that it does not comply with its obligations, it shall limit the Where appropriate, it shall issue, suspend or revoke the notification, taking into account the extent to which these requirements have not been met or where these obligations have not been complied with. It shall forthwith inform the European Commission and the other Member States of the European Union thereof.

(2) In the event of a restriction, suspension or revocation of the notification, or where the notified body cees its activity, the notified body concerned by the amendment to the notification shall forward the files for further processing to a other notified body, and shall ensure that they are kept ready for the notifying authority and the market surveillance authority at their request.

Challenge to the competence of notified bodies

§ 24. (1) The Federal Minister for Science, Research and the Economy shall grant the European Commission for the investigation of those cases in which it is responsible for the competence of a notified body or for the permanent fulfilment of the relevant requirements. and obligations by a notified body, doubts or doubts shall be brought to the attention of a notified body at the request of any information on the basis of the notification or maintenance of the competence of the notified body.

(2) In accordance with Article 28 (4) of Directive 2014 /34/EU, the European Commission shall adopt an implementing act if it finds that a notified body does not or no longer fulfils the conditions for its notification. The Federal Minister for Science, Research and the Economy, as the notifying authority, shall, if necessary, take corrective measures, including a withdrawal of the notification, on the basis of the European Commission's determination.

Obligations of notified bodies in relation to their work

§ 25. The notified bodies shall carry out the conformity assessment in accordance with the conformity assessment procedures as set out in Annexes III to VII and Annex IX.

(2) Compliance assessments shall be carried out in accordance with proportionality, avoiding unnecessary burdens on economic operators. The notified bodies shall have their activities taking due account of the size of a company, the industry in which it operates, its structure and the degree of complexity of the product technology concerned and of the product technology concerned. Mass production or series character of the manufacturing process. However, in doing so, they must act so strictly and comply with such a level of protection as is necessary for the conformity of the product with the requirements of this Regulation.

(3) A notified body shall establish that a manufacturer has not complied with the essential health and safety requirements set out in Annex II or in the relevant harmonised standards or other technical specifications. , it shall require the manufacturer to take appropriate corrective measures and shall not issue a certificate.

(4) Where a notified body has already issued a certificate and establishes, in the context of the monitoring of conformity, that the product is no longer in conformity, it shall require the manufacturer to take appropriate corrective measures; and has the certificate or to suspend or withdraw the authorisation if necessary.

(5) Where corrective measures are not taken or they do not have the necessary effect, the notified body shall, where appropriate, have all the certificates and/or certificates issued by the competent authorities. To restrict, suspend or withdraw authorisations.

Reporting requirements of notified bodies

§ 26. (1) The notified bodies shall report to the Federal Minister for Science, Research and the Economy:

1.

any refusal, restriction, suspension or withdrawal of a certificate or an authorisation,

2.

all the circumstances, the consequences for the scope or the conditions of the notification;

3.

any request for information on the conformity assessment activities which they have received from the market surveillance authority,

4.

at the request of which conformity assessment activities they have followed in the scope of their notification and which other activities, including cross-border activities and subcontracting, have carried out them.

2. The notified bodies shall carry out similar conformity assessment activities and cover the same products to the other bodies notified in accordance with Directive 2014 /34/EU, relevant information on the negative and on the negative Requests also to be sent on the positive results of conformity assessments.

Coordination of notified bodies

§ 27. In accordance with Article 33 of Directive 2014 /34/EU, the notified bodies must participate directly or through notified representatives in the work of a coordination group which is responsible for appropriate coordination and cooperation between the parties in the framework of the of this Regulation shall be established and duly continued by the European Commission.

Section 5

Supervision of the Union market, control of products imported into the Union market, protection of small-goods vehicles

Supervision of the Union market and control of products entering the Union market

§ 28. (1) For products, Article 15 (3) and Articles 16 to 29 of Regulation (EC) No 765/2008 apply.

Procedures for the treatment of products with which a risk is associated

§ 29. Where the market surveillance authority has reasonable grounds to believe that a product governed by this Regulation poses a risk to the health or safety of humans or to domestic and commercial animals or goods, it shall have sufficient reason to believe that: assess whether the product in question meets all the relevant requirements laid down in this Regulation. To this end, the economic operators concerned shall cooperate with the market surveillance authority to the extent necessary. If, in the course of the assessment referred to in paragraph 1, the market surveillance authority concludes that a product does not comply with the requirements of this Regulation, it shall, without delay, invite the economic operator concerned to: to take all appropriate corrective measures to ensure the conformity of the product with those requirements, to withdraw it or to recall it, in accordance with the nature of the risk, as required by the Authority. The market surveillance authority shall inform the relevant notified body. Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in this paragraph.

(2) If the market surveillance authority considers that the non-compliance is not restricted to the domestic market, it shall inform the Federal Minister for Science, Research and the Economy of this and, for its part, has the European the Commission and the other Member States of the European Union on the results of the evaluation and the measures to which the economic operator has been asked to inform. The Federal Minister for Science, Research and the Economy announcites notifications from other Member States of the European Union on products with non-compliance of the Market Surveillance Authority in a suitable manner.

(3) The economic operator shall ensure that all appropriate corrective measures which it takes extend to all the products concerned which it has placed on the market or made available on the market in the European Union.

(4) Within the period referred to in paragraph 1, the economic operator concerned does not take appropriate corrective measures, the market surveillance authority shall take all appropriate provisional measures to ensure that the product is made available on the domestic market. Prohibit or restrict the market, take the product off the market or recall it. The Federal Minister for Science, Research and the Economy shall immediately inform the European Commission and the other Member States of the European Union of these measures.

(5) From the information referred to in paragraph 4 all available information shall be required, in particular the data for the identification of the non-conforming product, the origin of the product, the nature of the alleged non-compliance and the risk as well as the nature and duration of the national measures taken and the arguments of the relevant economic operator. The Federal Minister for Science, Research and the Economy, in particular, indicates whether the non-compliance is due to one of the following causes:

1.

The product does not meet the requirements for the health or safety of humans or the protection of domestic animals or goods, or

2.

the harmonized standards, where compliance with Article 13 is subject to a presumption of conformity, are deficient.

(6) If another Member State has initiated the procedure, the Federal Minister for Science, Research and Economic Affairs shall immediately inform the European Commission and the other Member States of the European Union of any Measures and any other available information on the non-compliance of the product and, if it does not agree with the notified national measure, on its objections.

If, within three months of receiving the information referred to in paragraph 4, no other Member State or the European Commission does not consider an objection to a provisional measure by the Market Surveillance Authority, that measure shall be deemed to have been: justified.

(8) The Market Surveillance Authority shall ensure that appropriate restrictive measures, such as the withdrawal of the product from the market, are immediately taken with regard to the product concerned.

Conformable products posing a risk

§ 30. (1) According to an assessment pursuant to Article 29 (1) of the Market Surveillance Authority, it is established that a product poses a risk to the health or safety of humans or to domestic and commercial animals or goods, although with this it shall require the economic operator concerned to take all appropriate measures to ensure that the product in question no longer has this risk when placing the product on the market or that it does not comply with the requirements of the within a reasonable, reasonable period of time, which it may prescribe, is withdrawn or recalled.

(2) The economic operator shall ensure that the corrective measures which it takes shall cover all the products concerned which it has made available on the market in the European Union.

(3) The Federal Minister for Science, Research and the Economy shall immediately inform the European Commission and the other Member States of the European Union thereof. From this information, all available information must be provided, in particular the data for the identification of the product concerned, its origin, its supply chain, the nature of the risk, and the nature and duration of the national measures taken. Measures.

Formal non-compliance

§ 31. (1) Without prejudice to Article 29 (1), the market surveillance authority shall require the economic operator concerned to correct the non-conformity in question if it finds one of the following cases:

1.

the CE marking has been affixed in the event of non-compliance with Article 30 of Regulation (EC) No 765/2008 or by Article 17;

2.

the CE marking has not been affixed;

3.

the special explosion protection mark , the marks referring to the category and category of equipment and, where appropriate, the other markings and information referred to in Annex II, Z 1.0.5, have not been affixed;

4.

the identification number of the notified body, if this body was involved in the production control phase, was affixed or was not applied in the event of non-compliance with § 17;

5.

the EU declaration of conformity or, where appropriate, the certificate of conformity is not attached to the product;

6.

the EU declaration of conformity or the certificate of conformity has not been duly issued;

7.

the technical documentation is either not available or is not complete;

8.

the information referred to in § 7 (7) or § 9 (3) is missing, are false or incomplete;

9.

A different requirement pursuant to § 7 or § 9 is not fulfilled.

(2) If the non-compliance referred to in paragraph 1 continues, the market surveillance authority shall take all appropriate measures to restrict or prohibit the supply of the product on the market or to ensure that: is recalled or withdrawn from the market.

6.

Transitional and final provisions

Transitional provisions

§ 32. (1) The market surveillance authority shall not prevent products from being made available on the market; shall be put into service which fall within the scope of the explosion protection regulation in 1996 and which comply with the provisions of this Regulation and which have been placed on the market on or before 20 April 2016.

Certificates issued in accordance with Directive 94 /9/EC shall remain valid within the framework of this Regulation.

(3) References to Directive 94 /9/EC shall be construed as references to Directive 2014 /34/EU.

entry into force

§ 33. This Regulation shall enter into force on 20 April 2016. At the same time, the explosion protection regulation 1996, BGBl. No 252/1996, except for force.

Linguistic equality

§ 34. To the extent that personal names are referred to in this Regulation only in male form, they shall refer to women and men in the same way. The gender-specific form is to be used in the application to certain persons.

Mitterlehner

ANNEX I

Decision criteria for the classification of equipment groups in categories

Essential requirements

1. General requirements

1.

Equipment Group I

a)

Equipment category M 1 shall include equipment designed in a constructive manner and, if necessary, in addition to special protective measures, so as to be capable of being operated in accordance with the characteristics specified by the manufacturer. and ensure a very high level of security. The equipment of this category is intended for use in underground mines and their installations, which are endangered by pit gas and/or combustible dusts. Devices of this category must continue to operate in existing explosive atmospheres, even in the case of rare equipment disruptions, and therefore have explosion protection measures, so that:

-

in the event of failure of an apparatus protection measure, at least one second independent apparatus for protective equipment ensures the necessary safety; or

-

in the event of two independent errors, the necessary security is ensured.

The equipment of this category shall comply with the more stringent requirements set out in Annex II Z 2.0.1.

b)

Equipment category M 2 includes equipment designed to be designed to be operated in accordance with the characteristics specified by the manufacturer and to ensure a high degree of safety. Equipment of this category shall be intended for use in underground mines and their installations which may be endangered by mine gas and/or combustible dusts. The equipment must be designed to be switched off when an explosive atmosphere occurs. The equipment explosion protection measures within this category ensure the necessary level of safety during normal operation, even under heavy operating conditions and in particular in the case of rough treatment and changing environmental influences. The equipment of this category shall comply with the more stringent requirements set out in Annex II, Z 2.0.2.

2.

Equipment Group II

a)

Equipment category 1 shall include equipment designed to be operated in accordance with the characteristics specified by the manufacturer and to ensure a very high level of safety. Equipment of this category shall be intended for use in areas where an explosive atmosphere consisting of a mixture of air and gases, vapours or mists or of dust/air mixtures is permanent or long-term or frequent exists. Equipment of this category must ensure the necessary level of safety even in the case of uncommon equipment disruptions and therefore have explosion protection measures, so that:

-

in the event of failure of an apparatus protection measure, at least one second independent apparatus for protective equipment ensures the necessary safety; or

-

in the event of two independent errors, the necessary security is ensured.

The equipment in this category shall comply with the more stringent requirements set out in Annex II Z 2.1.

b)

Equipment category 2 includes equipment designed to be designed to be operated in accordance with the characteristics indicated by the manufacturer and to ensure a high level of safety. Equipment of this category is intended for use in areas where it is expected that an explosive atmosphere consisting of gases, vapours, mists or dust/air mixtures will occasionally occur. The apparatus explosion protection measures of this category ensure the necessary level of safety even in the event of frequent equipment faults or fault conditions which are usually to be expected. The equipment in this category shall comply with the more stringent requirements set out in Annex II Z 2.2.

c)

Equipment category 3 includes equipment designed to be operated in accordance with the characteristics specified by the manufacturer and to ensure a normal level of safety. Equipment of this category shall be intended for use in areas where there is no risk of an explosive atmosphere occurring due to gases, vapours, fog or swirled dust, but if it nevertheless occurs, then all Probability after only rare and for a short period of time. Equipment of this category ensures the necessary level of safety during normal operation. The equipment of this category shall comply with the more stringent requirements set out in Annex II Z 2.3.

ANNEX II

Essential health and safety requirements for the design and construction of equipment and protective systems intended for use in potentially explosive atmospheres

Preliminary remarks

A.

The technical level of knowledge which changes rapidly must be applied immediately and as far as possible.

B.

For related devices according to § 2 para. 1 Z 2 lit. (b) the essential health and safety requirements shall apply only in so far as they are necessary for the safe and reliable functioning and handling of such equipment with a view to the risk of explosion.

1.

Common requirements for equipment and protective systems

1.0.

General requirements

1.0.1.

Principles of integrated explosion safety

The design of devices and protective systems for the intended use in potentially explosive atmospheres must be carried out according to the principles of integrated explosion safety. To this end, the manufacturer shall take measures to:

-

as a matter of priority, if it is possible to avoid explosive atmospheres which can be produced or released by the equipment and protective systems themselves;

-

prevent the inflammation of explosive atmospheres, taking into account electrical and non-electrical ignition source types, in individual cases;

-

in the event of an explosion which may cause the risk to humans and, where appropriate, of domestic and commercial animals or goods, by direct or indirect action, to stop them immediately and/or to the area of effect of explosion flames and explosion pressures to a sufficiently safe level.

1.0.2.

Equipment and protective systems shall be designed and manufactured, taking into account possible error conditions, in order to eliminate dangerous situations where possible.

Consideration should also be given to the reasonably foreseeable misuse.

1.0.3.

Special testing and maintenance conditions

Equipment and protection systems subject to special testing and maintenance conditions shall be designed and constructed in accordance with these conditions.

1.0.4.

Environment conditions

Equipment and protective systems shall be designed and constructed with respect to existing or foreseeable environmental conditions.

1.0.5.

Marking

The following minimum particulars must be clearly and permanently affixed to each device and protection system:

-

the name, registered trade name or registered trade mark and address of the manufacturer;

-

CE marking (see Annex II to Regulation (EC) No 765/2008),

-

the name of the series and the type,

-

where appropriate, the batch or serial number,

-

the year of construction,

-

the special explosion protection mark , followed by the identifier that refers to the device group and category,

-

for the equipment group II of the letter "G" (for areas in which explosive gas, vapour, fog, air mixtures are present) and/or

-

the letter "D" (for areas in which dust can form explosive atmospheres).

1.0.6.

Operating Instructions

a)

There must be an operating manual for each device or protection system, which shall contain the following minimum particulars:

-

the same information as for the labelling of equipment or protective systems (see Z 1.0.5), with the exception of the batch number or serial number and, where applicable, maintenance-relevant information (e.g. B. addresses of service workshops, etc.);

-

Information on or on the safe

-

Commissioning,

-

use,

-

assembly and disassembly,

-

maintenance (maintenance and fault management),

-

Equipping;

-

where necessary, the marking of areas at risk from pressure relief equipment;

-

where necessary, information on the training;

-

information which, without any doubt, makes it possible to decide whether the use of a device (in accordance with its designated category) or a protection system in the intended area is possible without danger under the conditions to be expected;

-

electrical parameters and pressures, maximum surface temperatures and other limit values;

-

if necessary, special conditions for use, including indications of non-objectionable use, which may be experienced in the experience;

-

if necessary, the basic features of the tools which can be attached to the device or protection system.

b)

The operating instructions shall include the plans and schemes necessary for the putting into service, maintenance, inspection, verification of the functioning and, where appropriate, repair of the equipment or protective system, together with all relevant information. in particular with regard to safety.

c)

With regard to safety aspects, the documents in which the equipment or protective system is presented must not be in conflict with the operating instructions.

1.1.

Selection of materials

1.1.1.

The materials used for the construction of equipment and protective systems shall not cause the triggering of an explosion, taking into account operationally foreseeable stresses.

1.1.2.

Within the limits of the operating limits foreseeable by the manufacturer, no reactions of the materials used may be carried out with the components forming the explosive atmosphere which lead to an impairment of explosion safety .

1.1.3.

Materials must be selected in such a way that foreseeable changes in their properties and their compatibility in combination with other materials do not lead to any reduction in safety, in particular with regard to: Corrosion behaviour, wear, electrical conductivity, mechanical strength, ageing resistance and the effects of temperature changes

1.2.

Construction and construction

1.2.1.

Equipment and protective systems shall be designed and manufactured in the field of explosion protection, taking into account the technical knowledge, in such a way as to ensure that they can be operated safely during their expected lifetime.

1.2.2.

The components intended for installation in equipment and protective systems or as spare parts shall be designed and manufactured in such a way as to be functionally reliable in terms of explosion protection for their intended purposes, if they are to be used in accordance with Instructions from the manufacturer are installed.

1.2.3.

Closed construction and prevention of leaks

For equipment from which flammable gases or dusts can exit, the closed construction should be provided as far as possible.

Where possible, equipment which has openings or leakages shall not permit the escape of gases or dusts, so that no explosive atmosphere can be formed outside the equipment.

Places where substances are entered or removed must, as far as possible, be planned and equipped in such a way as to ensure that no flammable substances can escape during filling or emptying.

1.2.4.

Dust deposits

Equipment and protective systems intended to be used in dust-loaded areas shall be designed in such a way as to ensure that dust deposits on their surfaces cannot be ignited.

In principle, dust deposits must be limited as far as possible. The equipment and protective systems must be easy to clean.

The surface temperatures of the equipment parts must clearly fall below the glow temperatures of the stored dust.

The layer thickness of the deposited dust should be considered with regard to heat stowage and, if necessary, be taken into account by temperature limitation.

1.2.5.

Additional protective measures

Equipment and protective systems, which may be exposed to external stresses of a particular nature, shall, if necessary, be accompanied by additional protective measures.

The equipment must withstand the corresponding loads without the explosion protection being impaired.

1.2.6.

Unsafe Open

Where equipment and protective systems are arranged in a housing or closure which are part of the explosion protection itself, it may only be possible to open it by means of a special tool or suitable protective measures.

1.2.7.

Protection against other risks

Equipment and protective systems must be designed and manufactured in such a way that:

a)

to avoid injury or other damage which could be caused by direct or indirect contact;

b)

ensure that no hazardous surface temperatures or hazardous radiation occur on accessible equipment;

c)

experience shows that non-electrical hazards are excluded;

d)

is to ensure that predictable overload conditions do not cause dangerous situations.

Where the risks referred to in this Z, originating from equipment and protective systems, are covered in whole or in part by other European Union legislation, this Regulation shall apply to such equipment and protective systems and to those risks. not, or shall not apply to the latter from the date of application of this specific piece of legislation of the European Union.

1.2.8.

Device overload

Dangerous overloads of the devices have already been encountered in the development with integrated devices for measuring, control and control technology, in particular with overcurrent triggers, temperature limiters, differential pressure switches, Flow monitors, time relays, speed monitors and/or related monitoring devices.

1.2.9.

Pressure-resistant encapsulation devices

If parts which can ignite an explosive atmosphere are enclosed in a housing, it shall be ensured that the housing is able to withstand the pressure arising from the explosion of an explosive mixture inside and a transmission the explosion on the explosive atmosphere surrounding the housing is prevented.

1.3.

Potential sources of ignition

1.3.1.

Hazards due to different ignition source types

Sparks, flames, arcs of light, high surface temperatures, sound energies, radiation in the optical field, electromagnetic waves as well as other types of ignition source with ignitable potential must not be created.

1.3.2.

Hazards due to static electricity

Electrostatic charges, which can lead to hazardous discharge processes, must be avoided by suitable measures.

1.3.3.

Hazards due to electrical stress and leakage currents

Electrical scattering and leakage currents in conductive device parts, which lead, for example, to the formation of ignition-capable sparks, overheating of surfaces or dangerous corrosion, must be prevented.

1.3.4.

Hazards caused by inadmissible warming

Inadmissible warms caused by rubbing and percussion For example, between materials, rotating parts or the penetration of foreign bodies, it is possible to avoid as far as possible a constructive approach.

1.3.5.

Pressure balancing hazards

Equipment and protective systems shall be designed or equipped with integrated measuring, control and control equipment in such a way as to avoid the generation of shock waves or compressions originating from pressure equalisation processes which result in an explosion. can bring about.

1.4.

Hazards caused by external interference

1.4.1.

The equipment and protective systems shall be designed and constructed in such a way as to ensure that they are also used in changing environmental conditions, under the influence of external stresses, in the event of humidity, vibration, pollution and other external conditions. Fault influences within the limits of the operating conditions specified by the manufacturer reliably fulfil their intended function.

1.4.2.

Equipment parts must be proportionate to the mechanical and thermal stresses provided for, and must withstand the effects of existing or foreseeable aggressive substances.

1.5.

Requirements for safety devices

1.5.1.

Safety devices must function independently of the measuring and/or control devices required for operation.

Where possible, the failure of a safety device must be detected fast enough by appropriate technical measures, so that dangerous states cannot occur with high probability.

In principle, the principle of safe misconduct (fail-safe) is to be applied.

Safety-related switching operations must, in principle, act directly on the corresponding actuator without software control.

1.5.2.

Where possible, the device and/or protection system must be transferred to a safe state in the event of failure of safety devices.

1.5.3.

Emergency switches of safety devices must, as far as possible, have re-switching locks. A new start command should only be possible for normal operation if the reconnection locks have been deliberately removed beforehand.

1.5.4.

Operating and display devices

If the operating and display devices are used, they shall be designed in accordance with ergonomic principles with regard to the risk of explosion, in order to achieve the highest level of operational safety.

1.5.5.

Requirements for devices with a measuring function for explosion protection

Devices with a measuring function that influence devices in potentially explosive atmospheres are, in particular, to design and build the foreseeable operating requirements and special operating conditions accordingly.

1.5.6.

The display accuracy and functionality of devices with a measuring function must be able to be checked if required.

1.5.7.

The design of devices with a measuring function must be based on a safety factor which ensures that the alarm threshold, in particular taking into account the operating conditions of the device and any deviations in the measuring system, is sufficiently far out of the explosion and/or ignition limits of the atmospheres to be detected.

1.5.8.

Risk through software

In the design of devices, protective systems and security devices that are software-controlled, the risks must be taken into account in particular by errors in the program.

1.6.

Integration of safety-related system requirements

1.6.1.

Equipment running in automatic operation and protective systems which deviate from the intended operation must be able to be switched off by hand, provided that this does not impair safety.

1.6.2.

When operating the emergency cut-off devices, stored energies must be removed as quickly and safely as possible, so that they lose their driving effect.

This does not apply to electrochemically stored energies.

1.6.3.

Hazards caused by power failure

In the case of devices and protective systems in which an energy failure can lead to additional risks, a safe operating state must be maintained independently of the rest of the operating system.

1.6.4.

Ports driven

Equipment and protective systems shall be equipped with appropriate ducts for cables and cables.

Equipment and protective systems intended to be used in conjunction with other equipment or protective systems shall be secure with respect to the interfaces.

1.6.5.

Arrangement of warning devices as part of a device

Where equipment or protective systems are equipped with detector or warning devices to indicate the occurrence of explosive atmospheres, information shall be required which shall enable the equipment to be properly installed.

2.

More stringent requirements for equipment

2.0.

Requirements for equipment of device group I

2.0.1.

Requirements for equipment category M 1 of equipment group I

2.0.1.1.

The equipment must be designed and manufactured in such a way that ignition sources do not become effective even in the case of rare equipment malfunctions.

They must be equipped with explosion protection measures, so that:

-

in the event of failure of an apparatus protection measure, at least one second independent apparatus for protective equipment ensures the necessary safety; or

-

in the event of two independent errors, the necessary level of security is ensured.

Where necessary, the equipment must also be provided with special protective measures.

They must be able to continue operating in the presence of an explosive atmosphere.

2.0.1.2.

The equipment must be constructed in such a way that no dust can penetrate into it, where necessary.

2.0.1.3.

The surface temperatures of the equipment parts must be clearly below the ignition temperature of foreseeable dust/air mixtures with regard to the non-ignition of swirled dust.

2.0.1.4.

The devices shall be designed in such a way that the opening of equipment parts, which may be ignition sources, is only possible in an energy-free or intrinsi-safe state. If a device cannot be deactivated, the manufacturer must attach a warning to the device parts which can be opened.

Where necessary, the equipment shall be equipped with appropriate additional locking mechanisms.

2.0.2.

Requirements for equipment category M 2 of equipment group I

2.0.2.1.

The equipment must be equipped with protective equipment to ensure that ignition sources do not become effective in normal operation, even under difficult conditions and in particular harsh treatment and changing environmental influences.

When an explosive atmosphere occurs, the devices must be able to be switched off.

2.0.2.2.

The devices must be designed in such a way that the opening of equipment parts, which may be ignition sources, is only possible in the energy-free state or via corresponding locking systems. If a device cannot be deactivated, the manufacturer must attach a warning to the device parts which can be opened.

2.0.2.3.

With regard to dust explosion protection, the requirements of device category M 1 shall be complied with.

2.1.

Equipment category 1 requirements of device group II

2.1.1.

Explosive atmospheres caused by gases, vapors or fog

2.1.1.1.

The equipment shall be designed and manufactured in such a way that sources of ignition are avoided even in the event of equipment malfunctions which occur rarely.

They must be equipped with explosion protection measures, so that:

-

in the event of failure of an apparatus protection measure, at least one second independent apparatus for protective equipment ensures the necessary safety; or

-

in the event of two independent errors, the necessary level of security is ensured.

2.1.1.2.

For devices whose surfaces can be heated, it must be ensured that the highest surface temperatures mentioned above are not exceeded even in the worst case.

In this case, temperature increases due to heat stings and chemical reactions must also be taken into account.

2.1.1.3.

The devices shall be designed in such a way that the opening of equipment parts, which may be ignition sources, is only possible in an energy-free or intrinsi-safe state. If a device cannot be deactivated, the manufacturer must attach a warning to the device parts which can be opened.

Where necessary, the equipment shall be equipped with appropriate additional locking mechanisms.

2.1.2.

Explosive atmosphere due to dust/air mixtures

2.1.2.1.

The equipment shall be designed and manufactured in such a way as to prevent the ignition of dust/air mixtures, even in the event of a seldom occurring equipment malfunction.

They must be equipped with explosion protection measures, so that:

-

in the event of failure of an apparatus protection measure, at least one second independent apparatus for protective equipment ensures the necessary safety; or

-

in the event of two independent errors, the necessary level of security is ensured.

2.1.2.2.

Where necessary, the equipment shall be constructed in such a way as to allow dust to penetrate or leave it only at the points provided for it.

The intended introduction and connection parts must also satisfy this requirement.

2.1.2.3.

The surface temperatures of the equipment parts must be clearly below the ignition temperature of foreseeable dust/air mixtures with regard to the non-ignition of swirled dust.

2.1.2.4.

With regard to the driverless opening of the equipment, the relevant requirement 2.1.1.3 applies.

2.2.

Equipment category 2 requirements of device group II

2.2.1.

Explosive atmospheres caused by gases, vapors or fog

2.2.1.1.

The devices must be designed and manufactured in such a way that ignition sources are avoided even in the event of frequent equipment malfunctions or erroneous operating conditions, which usually have to be expected.

2.2.1.2.

With regard to the surface temperatures, the equipment parts must be designed and manufactured in such a way that they are not exceeded even in the case of unusual operating situations provided by the manufacturer.

2.2.1.3.

The devices must be designed in such a way that the opening of equipment parts, which may be ignition sources, is only possible in the energy-free state or via corresponding locking systems. If a device cannot be deactivated, the manufacturer must attach a warning to the device parts which can be opened.

2.2.2.

Explosive atmosphere due to dust/air mixtures

2.2.2.1.

The equipment must be designed and manufactured in such a way that it is not possible to ignite dust/air mixtures, even in the case of frequent equipment disturbances or fault conditions, which usually have to be expected to be expected.

2.2.2.2.

With regard to the surface temperatures, the requirement 2.1.2.3 applies.

2.2.2.3.

With regard to dust protection, requirement 2.1.2.2 shall apply.

2.2.2.4.

With regard to the driverless opening of the devices, the relevant requirement 2.2.1.3 applies.

2.3.

Requirements for equipment category 3 of equipment group II

2.3.1.

Explosive atmospheres caused by gases, vapors or fog

2.3.1.1.

The equipment shall be designed and manufactured in such a way as to avoid predictably expected ignition sources which may occur during normal operation.

2.3.1.2.

The surface temperatures that occur must not exceed the specified highest surface temperatures in the intended operation. In exceptional circumstances, an excess shall be permitted only if special protection measures have been taken by the manufacturer.

2.3.2.

Explosive atmosphere due to dust/air mixtures

2.3.2.1.

The equipment shall be designed and manufactured in such a way as to ensure that dust/air mixtures are not ignited by ignition sources which are to be expected in operation.

2.3.2.2.

With regard to the surface temperatures, the requirement 2.1.2.3 applies.

2.3.2.3.

The equipment, including the intended insertion and connection parts, shall be so constructed, taking into account the size of the dust particles, in such a way that neither explosive dust/air mixtures nor dangerous accumulations of dust are formed inside the interior of the equipment. .

3.

More stringent requirements for protection systems

3.0.

General requirements

3.0.1.

Protection systems must be dimensioned in such a way that the effects of explosions are limited to a sufficiently safe level.

3.0.2.

The protection systems must be designed and arranged in such a way as to prevent the transfer of explosions by dangerous chain reactions and flame-jet detonations, as well as transitions from ongoing explosions in detonations.

3.0.3.

In the event of a failure of the energy supply, the protective systems must maintain their operability over a reasonable period of time, so as to avoid dangerous situations.

3.0.4.

Protective systems must not be misleaned under the influence of external interference effects.

3.1.

Project planning and planning

3.1.1.

Material properties

In the project planning of the material properties, the expected explosion pressure shall be taken into account, taking into account extreme operating conditions, as the maximum explosion pressure as well as the expected thermal effect of the flame.

3.1.2.

Protective systems that serve to hold back or undercontrol explosions must be able to withstand pressure surges without losing their system integrity.

3.1.3.

The fittings connected to the protective systems must withstand the maximum explosion pressure to be expected without losing their functionality.

3.1.4.

The pressure conditions to be expected in peripheral equipment and connected pipe sections shall be taken into account in view of their retroactive effect in the planning and project planning phase of the protective systems for the explosive situation.

3.1.5.

Discharge facilities

If it is to be expected that the protective systems used are to be stressed beyond their material strength, suitable relief devices are to be projected in a non-hazardous manner in a person present in the immediate vicinity.

3.1.6.

Explosion suppression systems

Explosion suppression systems must be designed and designed in such a way that in the event of an event they detect the current explosion at an earliest possible time and, taking into account the maximum time pressure increase and the maximum time limit, the explosion suppression systems must be designed and designed to be able to detect the explosion. Optimally counteract the explosion pressure.

3.1.7.

Explosion-oriented decoupling systems

Decoupling systems, which are designed to remove certain equipment by means of appropriate devices in the shortest possible time, must be designed and designed in such a way as to ensure the safety of the ignition and to ensure that they are capable of being used for the protection of the ignition. Mechanical load-bearing capacity under conditions of use.

3.1.8.

The protective systems must be integrated into a circuit design with a suitable alarm threshold, so that, if necessary, the product supply and discharge and those parts of the equipment are switched off, the said components being a safe one. Do not ensure operation anymore.

ANNEX III

Module B: EU type-examination

1.

The EU type-examination is the part of a conformity assessment procedure, in which a notified body examines and certifies the technical design of a product and certifies that it is the product of the product. Requirements of this Regulation.

2.

The EU type-examination will be carried out as a test of a sample of the complete product (model) which is representative of the planned production.

3.

The application for EU type-examination must be submitted by the manufacturer to a single notified body of his choice.

The application shall contain the following:

a)

the name and address of the manufacturer and, if the application is submitted by the authorised representative, the name and address of the person concerned;

b)

a written declaration that the same application has not been lodged with any other notified body;

c)

the technical documentation. On the basis of these documents, it must be possible to assess the conformity of the product with the applicable requirements of this Regulation; it must contain a suitable risk analysis and assessment. The technical documentation shall be accompanied by the requirements in force and shall cover the design, manufacture and operation of the product in so far as they are relevant to the assessment. The technical documentation shall contain at least the following elements:

i)

a general description of the product,

ii)

Designs, manufacturing drawings and plans of components, assemblies, circuits, etc.,

iii)

descriptions and explanations necessary for the understanding of the above drawings and plans and the functioning of the product;

iv)

a list of harmonised standards, the references of which have been published in the Official Journal of the European Union, in full or in part, and, where these harmonized standards have not been applied, a description, which solutions have complied with the essential health and safety requirements of this Regulation, including a list of which other relevant technical specifications have been applied. In the case of harmonised standards partially applied, the parts which have been applied shall be indicated in the technical documentation,

v)

the results of design calculations, tests, etc. and

vi)

the audit reports

d)

samples representative of the production in question. The notified body may request additional samples if it is necessary to carry out the test programme.

4.

The notified body shall carry out the following tasks:

4.1.

Examination of the technical documentation, verification of the design of the specimen in accordance with the technical documentation, and the determination of the parts which have been designed in accordance with the applicable harmonised standards and which parts have been designed in accordance with other relevant technical specifications;

4.2.

Implementation or To determine whether the solutions from the relevant harmonised standards have been correctly applied, provided that the manufacturer has chosen to apply the appropriate tests and tests,

4.3.

Implementation or To determine whether the solutions adopted by a manufacturer using solutions derived from other relevant technical specifications shall determine whether the appropriate tests and tests are carried out in order to determine whether the solutions adopted by a manufacturer are to be found to be meet health and safety requirements of this Regulation, if it has not applied the solutions from the relevant harmonised standards;

4.4.

Agreement with the manufacturer, where the examinations and tests are carried out.

5.

The notified body shall draw up an audit report on the measures carried out in accordance with Z 4 and the results obtained. Without prejudice to its obligations to the notifying authority, the notified body shall publish the contents of this report or parts thereof only with the consent of the manufacturer.

6.

Where the design corresponds to the requirements of this Regulation applicable to the product concerned, the notified body shall issue the manufacturer with an EU type-examination certificate. This certificate shall contain the name and address of the manufacturer, the results of the examination, any conditions for its validity and the information required for the identification of the approved type. The EU type-examination certificate may be attached to one or more annexes.

The EU type-examination certificate and its annexes shall contain all the relevant information on the basis of which the conformity of the manufactured products with the tested design shall be assessed and, where appropriate, a check after their entry into service can be performed.

Where the design does not comply with the applicable requirements of this Regulation, the notified body shall refuse to issue an EU type-examination certificate and shall inform the applicant thereof, in which case the applicant shall give a detailed view of its refusal to grant the certificate. is based.

7.

The notified body shall keep informed of any changes in the generally accepted state of the art; if it indicates that the approved type of construction no longer meets the applicable requirements of this Regulation, it shall take a decision. Whether or not such changes require further investigation. If this is the case, the notified body shall inform the manufacturer thereof.

The manufacturer shall inform the notified body which has received the technical documentation relating to the EU type-examination certificate of any changes to the approved type, which shall be consistent with the essential health and safety requirements. the safety requirements of this Regulation or the conditions for the validity of this certificate. Such changes require an additional authorisation in the form of an addition to the original EU type-examination certificate.

8.

Each notified body shall inform its notifying authority of the EU type-examination certificates and/or any additions to which it has issued or withdrawn, and shall transmit to its notifying authority in regular Any such certificates and/or supplements to which they are refused, suspended or otherwise restricted shall be established at intervals or at the request of the Commission.

Each notified body shall inform the other notified bodies of the EU type-examination certificates and/or any additions thereto which they have refused, withdrawn, suspended or otherwise restricted, and shall inform them of the need to: if requested to do so, all such certificates and/or additions issued by it shall be included in the case.

If they so request, the European Commission, the Member States and the other notified bodies will receive a copy of the EU type-examination certificates and/or their additions. The European Commission and the Member States shall, on request, receive a copy of the technical documentation and the results of the tests carried out by the notified body. The notified body shall keep a copy of the EU type-examination certificate, including its annexes and additions, and the technical dossier, including the documents submitted by the manufacturer, until such time as the validity of the certificate is valid. Certificate ends.

9.

The manufacturer shall keep a copy of the EU type-examination certificate, together with the annexes and additions, together with the technical documentation, ready for the market surveillance authority for 10 years after the product has been placed on the market.

10.

The authorised representative of the manufacturer may submit the application referred to in Z 3 and comply with the obligations laid down in Z 7 and 9 if they are laid down in the contract.

ANNEX IV

Module D: Conformity with the design on the basis of a quality assurance related to the production process

1.

Conformity with the design on the basis of a quality assurance related to the production process is the part of a conformity assessment procedure in which the manufacturer is subject to the obligations laid down in z 2 and 5. , and shall ensure, on its own responsibility, that the products in question comply with the design model described in the EU type-examination certificate and fulfil the requirements of this Regulation applicable to them.

2.

Manufacture

The manufacturer shall operate an approved quality assurance system for the manufacture, final inspection and testing of the products concerned in accordance with Z 3 and shall be subject to surveillance in accordance with Z 4.

3.

Quality assurance system

3.1.

In the case of a notified body of its choice, the manufacturer shall request the evaluation of its quality system for the products concerned.

The application shall contain the following:

a)

the name and address of the manufacturer and, if the application is submitted by the authorised representative, the name and address of the person concerned;

b)

a written declaration that the same application has not been lodged with any other notified body;

c)

all relevant information relating to the product category envisaged;

d)

the documents relating to the quality system;

e)

the technical documentation relating to the approved type and a copy of the EU type-examination certificate.

3.2.

The quality system shall ensure conformity of the products with the type of construction described in the EU type-examination certificate and with the requirements of this Regulation applicable to them.

All the elements, requirements and requirements taken into account by the manufacturer must be systematically and properly put together in the form of written principles, procedures and instructions. These documents relating to the quality assurance system must enable a uniform interpretation of the quality programmes, plans, manuals and reports.

In particular, they shall provide an adequate description of the following points:

a)

the quality objectives and the organisational structure, responsibilities and powers of the management in relation to product quality;

b)

appropriate manufacturing, quality control and quality assurance techniques, applied procedures and systematic measures provided for;

c)

the examinations and tests carried out before, during and after manufacture, indicating their frequency;

d)

the quality-relevant records, such as test reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.; and

e)

Means to monitor the achievement of the required product quality and the effective functioning of the quality assurance system.

3.3.

The notified body shall assess the quality system in order to determine whether it meets the requirements set out in Z 3.2.

In the case of each component of the quality assurance system which meets the relevant specifications of the relevant harmonised standard, it shall comply with those requirements.

In addition to experience with quality management systems, at least one member of the audit team has experience of the evaluation in the relevant product area and product technology, as well as knowledge of the applicable product Requirements of this Regulation. The audit also includes a visit to the premises of the manufacturer. The audit team checks the data in Z 3.1 lit. (e) technical documentation, in order to ensure that the manufacturer is able to identify the relevant requirements of this Regulation and to carry out the necessary tests to ensure that the conformity of the product with these requirements are guaranteed.

The decision shall be notified to the manufacturer. The communication must include the conclusion of the audit and the justification for the evaluation decision.

3.4.

The manufacturer undertakes to comply with the obligations of the approved quality assurance system and to ensure that it is always kept properly and efficiently.

3.5.

The manufacturer shall inform the notified body which has approved the quality system of any planned changes to the quality system.

The notified body shall assess all the proposed changes and decide whether the modified quality system still meets the requirements referred to in Z 3.2 or whether a re-evaluation is necessary.

It shall announce its decision to the manufacturer. The communication must include the conclusion of the examination and the justification for the evaluation decision.

4.

Monitoring under the responsibility of the notified body

4.1.

The purpose of monitoring is to ensure that the manufacturer complies with the obligations arising from the approved quality system.

4.2.

The manufacturer shall provide the notified body for the assessment of access to the manufacturing, inspection, testing and storage facilities and shall provide it with all the necessary documents, in particular:

a)

the documents relating to the quality system;

b)

the quality-relevant records, such as test reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.

4.3.

The notified body shall carry out audits on a regular basis to ensure that the manufacturer maintains and applies the quality assurance system and shall submit a test report to it.

4.4.

In addition, the notified body may carry out unannounced visits to the manufacturer. During such visits, the notified body may, if necessary, carry out product testing or have it carried out in order to satisfy itself of the proper functioning of the quality assurance system. The notified body shall submit a survey report to the manufacturer and, in the event of an audit, a report.

5.

CE marking, EU declaration of conformity and certificate of conformity

5.1.

The manufacturer shall affix the CE marking to each individual product which is not a component and which complies with the design model described in the EU type-examination certificate and satisfies the applicable requirements, the CE marking and-under the Responsibility of the notified body referred to in Z 3.1-the identification number of the notified body.

5.2.

The manufacturer shall draw up a written EU declaration of conformity for each product model that is not a component, and shall keep it ready for the market surveillance authorities for ten years after placing the product on the market, which is not a component. The EU declaration of conformity must show the product model for which it was issued.

A copy of the EU declaration of conformity is attached to any product that is not a component.

5.3.

The manufacturer shall issue a written certificate of conformity for each component model and shall keep it ready for 10 years after the component has been placed on the market for the market surveillance authorities. The certificate of conformity must show the component model for which it has been issued. A copy of the certificate of conformity shall be attached to each component.

6.

The manufacturer shall, for 10 years after placing the product on the market, provide the following documents to the market surveillance authorities:

a)

the documents referred to in Z 3.1;

b)

the information with regard to the change in accordance with Z 3.5 in its approved form;

c)

the decisions and reports of the notified body according to Z 3.5, 4.3 and 4.4.

7.

Each notified body shall inform its notifying authority of the authorisations of quality assurance systems which it has issued or withdrawn and shall transmit to its notifying authority at regular intervals or on request. a list of all the authorisations of quality assurance systems which they have refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of the authorisations of quality assurance systems which it has refused, suspended, withdrawn or otherwise restricted, and at the request of the authorisations. of quality assurance systems that it has granted.

8.

Authorised representative

The manufacturer's obligations under Z 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative on his behalf and under his responsibility if they are laid down on behalf of the contract.

ANNEX V

Module F: Conformity with the design on the basis of a product test

1.

Conformity with the design on the basis of a test of the products shall be the part of a conformity assessment procedure in which the manufacturer fulfils the obligations laid down in the Z 2 and 5 and guarantees and their own responsibility states that the affected products subject to the provisions of Z 3 comply with the type of construction described in the EU type-examination certificate and satisfy the requirements of this Regulation applicable to them.

2.

Manufacture

The manufacturer shall take all measures necessary to ensure that the manufacturing process and its monitoring ensure that the products manufactured are in conformity with the type of design described in the EU type-examination certificate and with the aid of the the requirements of this Regulation.

3.

Review

A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests in order to ensure that the products conform to the approved type and the approved type as described in the EU type-examination certificate. to examine the requirements of this Regulation.

The examinations and tests to check the conformity of the products with the relevant requirements shall be carried out by means of examination and testing of each individual product in accordance with Z 4.

4.

Verification of conformity by examination and testing of each product

4.1.

All products shall be individually examined and the appropriate tests shall be carried out in accordance with the relevant harmonised standard (s) and/or equivalent tests, which shall be included in other relevant technical specifications. in order to verify their conformity with the approved type of design as described in the EU type-examination certificate and the applicable requirements of this Regulation.

In the absence of such a harmonised standard, the notified body shall decide which tests are to be carried out.

4.2.

The notified body shall draw up a certificate of conformity on the basis of these tests and tests and shall affix its identification number to each approved product or shall bear it under its responsibility.

The manufacturer shall keep the certificates of conformity ready for inspection for the market surveillance authorities for 10 years after placing the product on the market.

5.

CE marking, EU declaration of conformity and certificate of conformity

5.1.

The manufacturer shall apply to each individual product which is not a component and which complies with the type of construction approved and described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation, which: CE marking and-under the responsibility of the notified body referred to in Z 3-the identification number thereof.

5.2.

The manufacturer shall draw up a written EU declaration of conformity for each product model that is not a component, and shall keep it ready for the market surveillance authorities for ten years after placing the product on the market, which is not a component. The EU declaration of conformity must show the product model for which it was issued.

A copy of the EU declaration of conformity is attached to any product that is not a component.

Where the notified body referred to in Z 3 is correct, the manufacturer may, under the responsibility of that notified body, also apply the identification number of the notified body to the products which are not components.

5.3.

The manufacturer shall issue a written certificate of conformity for each component model and shall keep it ready for 10 years after the component has been placed on the market for the market surveillance authorities. The certificate of conformity must show the component model for which it has been issued. A copy of the certificate of conformity shall be attached to each component.

6.

Where the notified body agrees, the manufacturer may, under the responsibility of this notified body, attach the identification number of the notified body to the products during the production process.

7.

Authorised representative

The obligations of the manufacturer may be fulfilled by his authorised representative on his behalf and under his responsibility, provided that they are laid down on behalf of the manufacturer. An authorised representative must not comply with the obligations of the manufacturer set out in Z 2.

ANNEX VI

Module C1: Conformance with the design on the basis of an internal production control with monitored product tests

1.

Conformity with the design on the basis of an internal production control with monitored product tests is the part of a conformity assessment procedure in which the manufacturer specified in points Z 2, 3 and 4. Obligations as well as warranted and declared on its own responsibility that the products in question comply with the type of construction described in the EU type-examination certificate and the requirements of Part 2 of this Regulation which apply to them .

2.

Manufacture

The manufacturer shall take all measures necessary to ensure that the manufacturing process and its monitoring ensure that the products manufactured are in conformity with the type of design described in the EU type-examination certificate and with the aid of the the requirements of this Regulation.

3.

Product Checks

One or more tests of one or more specific aspects of the product shall be carried out by the manufacturer or on his behalf by the manufacturer or on his behalf, in order to conform to the product in the EU type-examination certificate shall be reviewed in accordance with the requirements of this Regulation. These tests shall be carried out under the responsibility of a notified body chosen by the manufacturer.

The manufacturer shall, under the responsibility of the notified body during the manufacturing process, bear the identification number of this point.

4.

CE marking, EU declaration of conformity and certificate of conformity

4.1.

The manufacturer shall affix the CE marking to each individual product which is not a component and which complies with the design model described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.

4.2.

The manufacturer shall draw up a written EU declaration of conformity for a product model that is not a component, and shall keep it ready for market surveillance authorities for 10 years after the product is placed on the market, which is not a component. The EU declaration of conformity must show the product model for which it was issued.

A copy of the EU declaration of conformity is attached to any product that is not a component.

4.3.

The manufacturer shall issue a written certificate of conformity for each component model and shall keep it ready for 10 years after the component has been placed on the market for the market surveillance authorities. The certificate of conformity must show the component model for which it has been issued. A copy of the certificate of conformity shall be attached to each component.

5.

Authorised representative

The manufacturer's obligations under Z 4 may be fulfilled by his authorised representative on his behalf and under his responsibility if they are laid down on behalf of the contract.

ANNEX VII

Module E: Conformity with the design on the basis of quality assurance based on the product

1.

Conformity with the design on the basis of a quality assurance based on the product is the part of a conformity assessment procedure, in which the manufacturer fulfils the obligations laid down in the Z 2 and 5 and ensures and on its own responsibility, declares that the products in question comply with the design model described in the EU type-examination certificate and that they comply with the requirements of this Regulation applicable to them.

2.

Manufacture

The manufacturer shall operate an approved quality assurance system for the final inspection and testing of the products concerned in accordance with Z 3 and shall be subject to surveillance in accordance with Z 4.

3.

Quality assurance system

3.1.

In the case of a notified body of its choice, the manufacturer shall request the evaluation of its quality system for the products concerned.

The application shall contain the following:

a)

the name and address of the manufacturer and, if the application is submitted by the authorised representative, the name and address of the person concerned,

b)

a written declaration that the same application has not been lodged with any other notified body;

c)

all relevant information relating to the product category envisaged,

d)

the documents relating to the quality system and

e)

the technical documentation relating to the approved type and a copy of the EU type-examination certificate.

3.2.

The quality system shall ensure conformity of the products with the type of construction described in the EU type-examination certificate and with the requirements of this Regulation applicable to them.

All the elements, requirements and requirements taken into account by the manufacturer must be systematically and properly put together in the form of written principles, procedures and instructions. These documents relating to the quality assurance system must enable a uniform interpretation of the quality programmes, plans, manuals and reports.

In particular, they shall provide an adequate description of the following points:

a)

the quality objectives and the organisational structure, responsibilities and powers of the management in relation to product quality;

b)

studies and tests carried out after manufacture;

c)

the quality-relevant records, such as test reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.,

d)

Means to monitor the effective functioning of the quality system.

3.3.

The notified body shall assess the quality system in order to determine whether it meets the requirements set out in Z 3.2.

In the case of each component of the quality assurance system which meets the relevant specifications of the relevant harmonised standard, it shall comply with those requirements.

In addition to experience with quality management systems, at least one member of the audit team has experience of the evaluation in the relevant product area and product technology, as well as knowledge of the applicable product Requirements of this Regulation. The audit also includes a visit to the premises of the manufacturer. The audit team checks the data in Z 3.1 lit. (e) technical documentation, in order to ensure that the manufacturer is able to identify the relevant requirements of this Regulation and to carry out the necessary tests to ensure that the conformity of the product with these requirements are guaranteed.

The decision shall be notified to the manufacturer. The communication must include the conclusion of the audit and the justification for the evaluation decision.

3.4.

The manufacturer undertakes to comply with the obligations of the approved quality assurance system and to ensure that it is always kept properly and efficiently.

3.5.

The manufacturer shall inform the notified body which has approved the quality system of any planned changes to the quality system.

The notified body shall assess all the proposed changes and decide whether the modified quality system still meets the requirements referred to in Z 3.2 or whether a re-evaluation is necessary.

It shall announce its decision to the manufacturer. The communication must include the conclusion of the examination and the justification for the evaluation decision.

4.

Monitoring under the responsibility of the notified body

4.1.

The purpose of monitoring is to ensure that the manufacturer complies with the obligations arising from the approved quality system.

4.2.

The manufacturer shall provide the notified body for the assessment of access to the manufacturing, inspection, testing and storage facilities and shall provide it with all the necessary documents, in particular:

a)

the documents relating to the quality system,

b)

the quality-relevant records, such as test reports and test data, calibration data, reports on the qualification of employees in this area, etc.

4.3.

The notified body shall carry out audits on a regular basis to ensure that the manufacturer maintains and applies the quality assurance system and shall submit a test report to it.

4.4.

In addition, the notified body may carry out unannounced visits to the manufacturer. During such visits, the notified body may, if necessary, carry out product testing or have it carried out in order to satisfy itself of the proper functioning of the quality assurance system. The notified body shall submit a survey report to the manufacturer and, in the event of an audit, a report.

5.

CE marking, EU declaration of conformity and certificate of conformity

5.1.

The manufacturer shall affix the CE marking to each individual product which is not a component and which complies with the design model described in the EU type-examination certificate and satisfies the applicable requirements, the CE marking and-under the Responsibility of the notified body referred to in Z 3.1-the identification number of the notified body.

5.2.

The manufacturer shall draw up a written EU declaration of conformity for each product model that is not a component, and shall keep it ready for the market surveillance authorities for ten years after placing the product on the market, which is not a component. The EU declaration of conformity must show the product model for which it was issued.

A copy of the EU declaration of conformity is attached to any product that is not a component.

5.3.

The manufacturer shall issue a written certificate of conformity for each component model and shall keep it ready for 10 years after the component has been placed on the market for the market surveillance authorities. The certificate of conformity must show the component model for which it has been issued. A copy of the certificate of conformity shall be attached to each component.

6.

The manufacturer shall, for 10 years after placing the product on the market, provide the following documents to the market surveillance authorities:

a)

the documents referred to in Z 3.1;

b)

the information with regard to the change in accordance with Z 3.5 in its approved form;

c)

the decisions and reports of the notified body according to Z 3.5, 4.3 and 4.4.

7.

Each notified body shall inform its notifying authority of the authorisations of quality assurance systems which it has issued or withdrawn and shall transmit to its notifying authority at regular intervals or on request. a list of all the authorisations of quality assurance systems which they have refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of the authorisations of quality assurance systems which it has refused, suspended or withdrawn and, at the request of a quality system, the authorisation of quality assurance systems, which shall: it has granted.

8.

Authorised representative

The manufacturer's obligations under Z 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative on his behalf and under his responsibility if they are laid down on behalf of the contract.

ANNEX VIII

Module A: Internal Manufacturing Control

1.

Internal production control shall be the conformity assessment procedure with which the manufacturer fulfils the obligations set out in points Z 2, 3 and 4 and ensures and declares on his own responsibility that the relevant Products shall comply with the requirements of this Regulation applicable to them.

2.

Technical documentation

The manufacturer shall draw up the technical documentation. On the basis of these documents, it must be possible to assess the conformity of the product with the requirements in question; it must contain a suitable risk analysis and assessment.

The technical documentation shall list the applicable requirements and shall cover the design, manufacture and operation of the product, insofar as they are relevant to the assessment. The technical documentation shall contain at least the following elements:

a)

a general description of the product,

b)

Designs, manufacturing drawings and plans of components, assemblies, circuits, etc.;

c)

descriptions and explanations necessary for the understanding of the above drawings and plans and the functioning of the product;

d)

a list of harmonised standards, the references of which have been published in the Official Journal of the European Union, in full or in part, and, where these harmonized standards have not been applied, a description, which solutions have complied with the essential health and safety requirements of this Regulation, including a list of which other relevant technical specifications have been applied. In the case of harmonised standards partially applied, the parts which have been applied shall be indicated in the technical documentation;

e)

the results of design calculations, tests, etc. and

f)

the audit reports.

3.

Manufacture

The manufacturer shall take all measures necessary to ensure that the production process and its monitoring comply with the conformity of the products with the technical documentation referred to in Z 2 and with the requirements of this Regulation applicable to them. .

4.

CE marking, EU declaration of conformity and certificate of conformity

4.1.

The manufacturer shall affix the CE marking to each individual product, which is not a component and which meets the applicable requirements of this Regulation.

4.2.

The manufacturer shall draw up a written EU declaration of conformity for a product model which is not a component and shall keep it, together with the technical documentation, for 10 years after the product has been placed on the market, which is not a component, for market surveillance authorities. The EU declaration of conformity must produce the product model for which it has been issued.

A copy of the EU declaration of conformity is attached to any product that is not a component.

4.3.

The manufacturer shall issue a written certificate of conformity for each component model and shall, together with the technical documentation, keep it ready for 10 years after the component has been placed on the market for the market surveillance authorities. The certificate of conformity must show the component for which it was issued. A copy of the certificate of conformity shall be attached to each component.

5.

Authorised representative

The manufacturer's obligations under Z 4 may be fulfilled by his authorised representative on his behalf and under his responsibility if they are laid down on behalf of the contract.

ANNEX IX

Module G: Conformity based on a single test

1.

Conformity based on an individual assessment shall be the conformity assessment procedure with which the manufacturer fulfils the obligations laid down in Z 2, 3 and 5 and ensures and declares on its own responsibility that: the product, subject to the provisions of Z 4, complies with the requirements of this Regulation applicable to it.

2.

Technical documentation

2.1.

The manufacturer shall draw up the documents and make them available to the notified body referred to in Z 4. On the basis of these documents, it must be possible to assess the conformity of the product with the requirements in question; it must contain a suitable risk analysis and assessment. The technical documentation shall be accompanied by the applicable requirements and shall cover the design, manufacture and operation of the product, insofar as they are relevant to the assessment. The technical documentation shall contain at least the following elements:

a)

a general description of the product,

b)

Designs, manufacturing drawings and plans of components, assemblies, circuits, etc.;

c)

descriptions and explanations necessary for the understanding of the above drawings and plans and the functioning of the product;

d)

a list of harmonised standards, the references of which have been published in the Official Journal of the European Union, in full or in part, and, where these harmonized standards have not been applied, a description, which solutions have complied with the essential health and safety requirements of this Regulation, including a list of which other relevant technical specifications have been applied. In the case of harmonised standards partially applied, the parts which have been applied shall be indicated in the technical documentation;

e)

the results of design calculations, tests, etc. and

f)

the audit reports.

2.2.

The manufacturer must keep the technical documentation ready for the market surveillance authorities for 10 years after the product has been placed on the market.

3.

Manufacture

The manufacturer shall take all measures necessary to ensure that the manufacturing process and its monitoring ensure the conformity of the manufactured products with the applicable requirements of this Regulation.

4.

Review

A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests in accordance with the relevant harmonised standards and/or equivalent tests, which shall be listed in other relevant technical specifications. through or have them carried out in order to verify the conformity of the product with the applicable requirements of this Regulation. In the absence of such a harmonised standard, the notified body shall decide which tests are to be carried out.

The notified body shall draw up a certificate of conformity on the basis of these tests and tests and shall affix its identification number to each approved product, or shall bear it under its responsibility.

The manufacturer shall keep the certificates of conformity ready for the market surveillance authorities for 10 years after placing the product on the market.

5.

CE marking, EU declaration of conformity and certificate of conformity

5.1.

The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in Z 4, the identification number thereof to each product which is not a component and which satisfies the applicable requirements of this Regulation.

5.2.

The manufacturer shall draw up a written EU declaration of conformity and shall keep it ready for the market surveillance authorities for ten years after the product, which is not a component, on the market. The EU declaration of conformity must show the product for which it was issued.

A copy of the EU declaration of conformity is attached to any product that is not a component.

5.3.

The manufacturer shall issue a written certificate of conformity and shall keep it ready for ten years after the component has been placed on the market for the market surveillance authorities. The certificate of conformity must show the component for which it was issued. A copy of the certificate of conformity shall be attached to each component.

6.

Authorised representative

The manufacturer's obligations under Z 2.2 and 5 may be fulfilled by his authorised representative on his behalf and under his/her responsibility, provided that they are laid down on behalf of the manufacturer.

ANNEX X

EU Declaration of Conformity (NR. xxxx)

1.

Product Model/Product (Product, Type, Charging or Serial Number):

2.

Name and address of the manufacturer and, where appropriate, of his authorised representative:

3.

The sole responsibility for the issue of this declaration of conformity is borne by the manufacturer.

4.

Purpose of the declaration (designation of the product for traceability: if necessary, an image may be added to identify the product):

5.

The above-mentioned subject-matter of the Declaration shall comply with the relevant Union harmonisation legislation:

6.

Indication of the relevant harmonised standards or of the other technical specifications on which the declaration of conformity has been based:

7.

Where appropriate, the notified body ... (name, identification number) ... (description of the measure) ... and the following certificate shall be issued:

8.

Additional information:

Signed for and on behalf of:

(Place and date of the exhibition):

(Name, function) (Signature):