Explosion Protection Directive 2015 - 2015 Exsv

Original Language Title: Explosionsschutzverordnung 2015 – ExSV 2015

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

On Reason

1.

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

2.

§ 181 of the MinroG MinroG MinroG, BGBl.  I n ° 38/1999, as last amended by the Federal Law BGBl.  I n ° 80/2015, as well as

3.

Section 3 (4) and (6), Section 7 (1), (5) and (6), and Section 7b (7) of the Electrical Engineering 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

1.
section General provisions

§ 1.

Scope

§ 2.

Transform

3.

Definitions

4.

Deployment on the market and commissioning

5.

Essential health and safety requirements

§ 6.

Free movement of goods

2.
section Duties of economic operators

7.

Manufacturers ' obligations

§ 8.

Plenipotentiary

9.

The duties of the leaders

10.

Dealer's obligations

11.

The circumstances under which the manufacturer's obligations also apply to Importer and trader apply

12.

Identification of economic agents.

3.
section Product compliance

13.

Conformance of products compliance

§ 14.

Compliance assessment procedures

15.

EU Declaration of Conformity

16.

General principles of CE marking

17.

Terms and Conditions for attaching the CE marking

4.
section Compliance Assessment

18.

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

19.

Requests to notified bodies

§ 20.

Conformance presumption in notified bodies

21.

Branch companies of notified bodies and award of Suborders

§ 22.

Notification procedure

§ 23.

Notification of change

24.

Feeding the competency of notified bodies

25.

The duties of notified bodies in relation to their work

26.

Reported posts reporting obligations

27.

Coordinating the notified bodies

5.
section Supervision of the Union market, control of products imported into the Union market, protection of the protection of the protection of the products concerned.

28.

Monitoring the Union market and controlling the on the EU market products

29.

Method of handling products with which a risk is connected

30.

Conformated products that represent a risk

§ 31.

Formal non-compliance

6.
section Transitional and final provisions

§ 32.

Transitional provisions

§ 33.

Entry into force

34.

Language Equal Treatment

I

Decision criteria for the classification of device groups in Categories

II

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

ANNEX III

Module B: EU type-examination

IV

Module D: Conformity with the building pattern on the basis of a Quality assurance related to the production process

V

Module F: Conformance with the construction pattern based on a Product Validation

VI

Module C1: Conformance to the pattern on the basis of a internal manufacturing control with monitored product checks

VII

Module E: Conformity with the construction pattern based on the Quality assurance related to the product

ANNEX VIII

Module A: Internal Manufacturing Control

ANNEX IX

Module G: Compliance based on a single audit

X

EU Declaration of Conformity (NR). xxxx)

1. Section

General provisions

Scope

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

1.

Devices and protective systems for intended use in potentially explosive atmoshields areas;

2.

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

3.

Components that are intended to be installed in the devices and protective systems referred to in Z 1.

(2) This Regulation does not apply to:

1.

Medical devices intended for use in medical areas;

2.

Devices and protective systems where the risk of explosion is solely due to the presence of Explosives or chemically unstable substances are caused;

.

Devices intended for use in a domestic and non-commercial environment, in which an explosive atmosphere is rare and can only be formed as a result of an unintended fuel outlet;

4.

Personal protective equipment within the meaning of Directive 89 /686/EEC on the approximation of Legislation of the Member States relating to personal protective equipment, OJ L 327, 31.12.2002 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.

Seeschiffe and movable off-shore facilities and equipment on board these ships, or Attachments;

6.

Transport equipment, i.e. vehicles and associated trailers, which are used exclusively for the Transport of persons in the air, on road and rail networks or on the waterway, and means of transport as far as they are intended for the transport of goods in the air, on public roads 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 paragraph 1 lit.  (b) the Treaty on the Functioning of the European Union, BGBl III No 86/1999, as amended by BGBl III No 314/2013.

Transform

§ 2. This Regulation provides for 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 No.  OJ L 96, 29.3.2014 p. 309, transposed into Austrian law.

Definitions

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

1.

"Devices": Machines, Operating Medium, Stationary or Mobile Devices, Control and equipment, as well as warning and prevention systems, which are intended individually or in combination for the production, transmission, storage, measurement, control and conversion of energy and/or the processing of materials, and the potential of their own potential Have ignition sources and cause an explosion ;

2.

"Protection Systems": all devices except for the components of devices that are running To stop explosions immediately and/or to limit the area affected by an explosion and to be provided separately on the market as autonomous systems;

3.

"Components": those components that are used for the safe operation of devices and protective systems are required without, however, performing an autonomous function;

4.

"explosive atmosphere": a mixture of air and flammable gases, vapours, mists, or dusts under atmospheric conditions, in which the combustion process is transferred to the whole unburned mixture after ignition has taken place;

5.

"hazardous area": an area in which the atmosphere is based on the local and operational conditions explosively;

6.

"Device Group I": Devices for use in underground mining operations and their Installations which may be endangered by mine gas and/or combustible dusts shall be determined, including the categories M1 and M2 listed in Annex I;

7.

"Device Group II": Devices that are used in the remaining areas, which are explosive atmospheres may be endangered, including the categories 1, 2 and 3 of the equipment listed in Annex I;

8.

"Device Category": the classification of devices within each device group in accordance with Annex I, from the provides the necessary level of security to ensure that it is guaranteed;

9.

"intended use": the use of a product in a way that is used by the The manufacturer is determined by assigning the device to a particular device group and category or by making all the information necessary for the safe operation of the protection system, the device or the component;

10.

"Delivery on the market": any delivery of a product for payment or free of charge. Distribution, consumption or use on the Union market in the context of a business activity;

11.

"Placing on the market": the initial deployment of a product on the Union market;

12.

"Manufacturer": any natural or legal person who makes a product or develop or manufacture, and market this product under its own name or trademark, or use it for its own purposes;

13.

"Plenipotentiary" means any natural or legal person established in the European Union, which has been commissioned by a manufacturer to carry out certain tasks in its name;

14.

"importer": any natural or legal person resident in the European Union who placing a product on the Union market from a third country;

15.

"Dealer": any natural or legal person in the supply chain who is a product on the market, with the exception of the manufacturer or the importer;

16.

"Economic agents": the manufacturer, the authorized agent, the importer, and the trader;

17.

"Technical Specification": a document in which the technical requirements are required to which a product must satisfy;

18.

harmonized standard ": a harmonised standard as defined in Art. 2 para. 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": the procedure for evaluating whether the essential health and security requirements of this Regulation to a product have been met;

20.

"Conformance assessment body": a body that has conformity assessment activities including calibrations, audits, certifications, and inspections;

21.

"callback" means any measure that already has the effect of returning one of the end-users for electrical equipment provided;

22.

"Withdrawal": any measure to prevent a supply chain from being used product is available on the market;

23.

"Union Harmonization Law": European Union legislation on Harmonisation of the conditions for the marketing of products;

24.

"CE Marking": Labeling that the manufacturer declares that the product is the shall comply with the requirements laid down in the European Union's harmonisation legislation on its affixing;

25.

"Market Surveillance Authority": one according to § 6 para. 1 MING, § 13 ETG 1992, or pursuant to § § 170, 171 MinroG competent authority to carry out market surveillance;

Deployment on the market and commissioning

§ 4. (1) Products may only be made available on the market and put into service if they are properly installed and maintained and used in accordance with their 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 this does not affect 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 shall be issued, provided that a visible sign clearly indicates that such products are do not comply with the requirements and cannot be acquired until the manufacturer has produced the conformity with 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 meet the essential health and safety requirements set out in Annex II, which are applicable to them, taking into account their intended use.

Free movement of goods

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

2. Section

Economic Operators ' duties

Obligations of manufacturers

§ 7. (1) Manufacturers must ensure that when they place their products on the market or use them for their own purposes, they must ensure that they are in accordance with the essential health and safety requirements. Security requirements in Annex II were designed and manufactured.

(2) Manufacturers must prepare the technical documentation in accordance with Annexes III to IX and have the conformity assessment procedure in question be carried out or carried out in accordance with § 14.

1.

This method has shown that the product that is not a component is , manufacturers shall draw up an EU declaration of conformity and attach the CE marking.

2.

A component has been proven with the appropriate conformity assessment procedure to show that a component The manufacturer shall issue a written certificate of conformity in accordance with § 14 (3).

Manufacturers ensure that each product is 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 the same user, a single copy can be attached to the batch or delivery concerned.

(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 date on which the product is placed on the market.

(4) Manufacturers must

1.

ensures that compliance with this Regulation is always compliant with this Regulation. Series production is ensured. Any changes to the design of the product or its characteristics, as well as modifications to the harmonised standards or other technical specifications referred to in the declaration of conformity of a product, shall be duly taken into account ;

2.

If this is considered appropriate in view of the risks posed by a product, in order to protect the health and safety of consumers, carry out sample checks on products made available on the market, examine them and, if necessary, register a list of complaints concerning non-compliant products; and Recall products and provide traders with this monitoring on the Keep running.

(5) Manufacturers must ensure that products they have placed on the market carry a type, batch or serial number or a different identifier for their identification, or, if this is due to the The size or nature of the product is not possible for the required information to be provided on the packaging or in the documents attached to the product.

(6) Manufacturers must ensure that products that have placed them on the market and are not components with the special explosion protection tag  and, if applicable, the other markings and information provided for 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 Indicate the packaging or the documents 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) The 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, understandable and clear.

(9) Manufacturers who consider or have reason to believe that a product which they have placed on the market does not comply with this Regulation shall immediately take the necessary corrective measures, in order to ensure the conformity of this 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 provide detailed information, in particular on the non-compliance and the corrective measures taken.

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

Authorized

§ 8. (1) A manufacturer may nominate 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 set out by the manufacturer, which shall be determined on behalf of the manufacturer. The contract shall allow the authorised representative to carry out at least the following tasks:

1.

Declaration of compliance with the EU declaration of conformity or, where applicable, the certificate of conformity and the technical documentation for the market surveillance authority over a period of 10 years after placing the product on the market;

2.

at the reasonable request of a market surveillance authority or one for the control of the External borders competent national authority shall provide all necessary information and documentation to demonstrate the conformity of a product to that authority;

.

at the request of the Market Surveillance Authority Cooperation for all measures to avert the Risks associated with products that are part of the role of the plenipotentiary.

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 complied with the requirements of § 7 (5), (6) and (7).

If 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 shall not be allowed to transport this product into circulation before the product has been brought into conformity. 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, on the product itself, have its name, company or registered trademark and postal address to which it may be contacted, or, if not possible, on the packaging or in the documents accompanying the product. 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 responsibility, the importer must ensure that the conditions of its storage or transport are consistent with the product's conformity with the essential health and safety requirements. and security requirements of Annex II.

(6) In the event that this is considered appropriate in view of the risks posed by a product, the importer shall have sample checks on the market for the protection of the health and safety of end-users. , to investigate complaints and, if necessary, to maintain a list of complaints, non-compliant products and product recalls, and to keep distributors informed of such monitoring.

(7) 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, in order to ensure the conformity of this 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 10 years, and ensure that they are able to submit the technical documentation on request.

(9) The importer must, at the request of the market surveillance authority, all the information and documents necessary to demonstrate the conformity of the product, in paper form or on the basis of a reasoned request. electronic means in German language. They must cooperate with this authority, at their request, in all measures to avoid risks associated with products that have placed them on the market.

Obligations of traders

§ 10. (1) The dealers must 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 labelled with the CE marking, where necessary, and that the EU declaration of conformity or the certificate of conformity as well as the required documents and the instructions for use and the safety information in German, and whether the manufacturer and the importer meet the requirements in accordance with § 7 (5), (6) and (7) and § 9 Paragraph 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, dealers must ensure that the conditions of its storage or transport are consistent with the product's compliance with the essential health and safety requirements. Security requirements of Annex II shall not be affected.

(4) Traders who are of the opinion or have reason to believe that a product made available on the market is not in conformity with this Regulation shall ensure that the necessary Corrective measures are taken to ensure the conformity of this product or, where appropriate, to withdraw or recall it. 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) The traders shall, at the request of the market surveillance authority, require all the information and documentation necessary to demonstrate the conformity of a product in paper form or on the basis of their reasoned request. make electronic means available. They must cooperate with this authority, at their request, in all measures to avoid risks associated with products that they have provided on the market.

Circumstances in which the manufacturer's obligations are also applicable to importer and trader

§ 11. A importer or trader shall be deemed to be a manufacturer for the purposes of this Regulation and shall be subject to the obligations of a manufacturer in accordance with § 7 if he/she is a product under his own name or of its own trade mark, or modifies a product already on the market in such a way that conformity with this Regulation can be affected.

Identification of economic operators

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

1.

of which they have purchased 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.

3. Section

Conformity of the product

Presumption Of Compliance of Products

§ 13. (1) Compliance with harmonised standards or parts of those products whose references have been published in the Official Journal of the European Union shall be subject to conformity with the essential health and safety requirements laid down in Annex II, 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 relevant national standards and standards are met by the person concerned. the technical specifications which are considered to be 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 in accordance with § 1 (1) (2) (2) as follows:

1.

For device groups I and II, device category M 1, and 1, the EU type-examination is in accordance with the Appendix III, in conjunction with one of the following:

)

Conformance with the construction pattern based on a quality assurance based on the Production Process according to Annex IV or

b)

Conformance with the construction pattern based on an inspection of the products in accordance with Annex V;

2.

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

)

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

)

Conformance with the design on the basis of an internal manufacturing control with monitored product tests in accordance with Annex VI,

bb)

Conformance with the construction pattern based on quality assurance based on the Product in accordance with Annex VII,

)

for the remaining devices of these groups and categories, the internal manufacturing control is in accordance with Annex VIII, and the technical documentation referred to in Annex VIII, Z 2, shall be sent to a notified body which shall immediately confirm the receipt of these documents and keep them in place;

3.

for device group II, device category 3 is the internal manufacturing control in accordance with Annex VIII

4.

for device groups I and II: In addition to the methods listed in Z 1, 2, and 3 of this paragraph, the conformity shall 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) (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 for 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 relation to the safety aspects referred to in Annex II, Z 1.2.7.

(5) By way of derogation from paragraphs 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 the the procedures referred to in (1), (2) and (4) have not been applied 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 written 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 structure to the specimen in Annex X, contains the elements specified in the relevant conformity assessment procedures of Annexes III to IX and is up to date on . It is to be translated into German for products that are placed on the market or made available on the market in Germany.

(3) A product of several European Union legislation, each requiring an EU declaration of conformity, is only a single EU declaration of conformity for all To issue EU legislation. This declaration shall indicate the legislation in force in the European Union and its reference in the Official Journal.

(4) With the exhibition of the EU Declaration of Conformity, the manufacturer shall take full responsibility for ensuring that the product meets the requirements of this Regulation.

General principles of CE marking

§ 16. The CE marking shall be subject to the general principles laid down in Article 30 of Regulation (EC) No 765/2008 on the requirements for accreditation and market surveillance relating to the CE marking with the marketing of products and repealing Regulation (EEC) No 339/93, OJ L 327, 31.12.1993, p.  OJ L 218, 13.8.2008 p.30

Rules and conditions governing the affixing of the CE marking

§ 17. (1) The CE marking is easily visible, legible and permanently affixed 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) The CE marking indicates the identification number of the notified body, if that body was involved in the production control stage. 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 special explosion protection flag shall be used, which shall: Identification 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) The CE marking and the markings, characteristics and information referred to in paragraph 4 and, where applicable, the identification number of the notified body may be another sign of a particular risk or risk. a particular use. Products designed for a certain explosive atmosphere must be labelled accordingly.

(6) The Market Surveillance Authority shall ensure that the system of CE marking is properly implemented and that, in the event of misuse of this marking, steps shall be taken in the To initiate the terms of § 9m ETG 1992.

4. Section

Conformity Assessment

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

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

(2) The Federal Minister for Science, Research and the Economy has notified the European Commission of its procedures for the evaluation and notification of conformity assessment bodies and for the monitoring of To inform and inform about any changes in this regard.

Requirements for notified bodies

§ 19. (1) A conformity assessment body has to 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 have legal personality.

(3) A conformity assessment body must 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 proven.

(4) A conformity assessment body, its top management level and the staff responsible for performing conformity assessment tasks may not design engineer, manufacturer, supplier, installer, buyer, owners, users or maintenance operations of the products to be evaluated or representatives 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 branch contractors or subcontractors do not ensure the confidentiality, objectivity and impartiality of their conformity assessment activities

(5) The conformity assessment body and its staff have the conformity assessment activities with the greatest possible degree of professionalism and the professional competence required in the area concerned. , they shall not be subject to any form of influence, in particular of a financial nature, which could have an impact on their assessment or the results of their conformity assessment work, and in particular by persons or groups of persons , which have an interest in the outcome 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, for which it has been notified; whether these tasks are fulfilled by the body itself, on its behalf, or under its responsibility.

A conformity assessment body must have at any time, in each conformity assessment procedure, and in any type and category of products for which it has been notified:

1.

The required staff with expertise and sufficient experience to complete the to perform the tasks of conformity assessment;

2.

Descriptions of procedures according to which the conformity assessment is performed in order to to ensure transparency and the repeatability of such procedures, and to have adequate instruments and procedures in place between the tasks it takes as the notified body and other activities; ;

3.

Procedure for performing activities with due regard to the size of a Company, the industry in which it operates, its structure, the degree of complexity of the respective product technology, and the fact that the 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 to be carried out with the conformity assessment, and have access to all necessary equipment or facilities.

(7) The staff responsible for carrying out the tasks of conformity assessment must have the following:

1.

A solid technical and vocational training system that includes all conformity assessment activities, for which the conformity assessment body has been notified;

2.

a sufficient knowledge of the requirements associated with the assessments to be performed , and sufficient authority to carry out such assessments;

.

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

4.

The ability to create certificates, logs, and reports as evidence of Assessments carried out.

(8) The impartiality of the conformity assessment body, its senior management level and the personnel responsible for the 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 their results.

(9) The conformity assessment bodies shall be covered by a liability insurance scheme.

(10) Information provided by the staff of a conformity assessment body in carrying out its tasks in accordance with Annexes III to VII and Annex IX or one of the relevant national implementing rules is subject to professional secrecy, but it does not apply to the market surveillance authority and to the Federal Minister for Science, Research and the Economy. Property rights are to 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 Directive 2014 /34/EU or 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.

Conformance presumption in notified bodies

§ 20. A conformity assessment body shall comply with the criteria of the relevant harmonised standards or parts thereof, the references of which shall be published in the Official Journal of the European Communities. Union shall be presumed to meet the requirements laid down in § 19, in so far as the applicable harmonised standards cover these requirements.

Branch companies of notified bodies and subcontracting

§ 21. (1) The notified body shall assign or transfer to a subcontractor certain tasks associated with the conformity assessment, which shall be: ensure that the subcontractor or the subsidiary meets the requirements of § 19, and to inform the Federal Minister for Science, Research and the Economy 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.

(4) The notified bodies shall have the relevant documentation concerning the assessment of the qualifications of the subcontractor or the branch undertaking and the documents referred to in Annexes III to VII and Annex IX thereto. shall be available for the notifying authority.

Notification procedure

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

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

Change of notification

§ 23. (1) If the Federal Minister for Science, Research and the Economy determines or is informed that a notified body no longer meets the requirements of § 19 or that it does not comply with its obligations, it shall, where appropriate, restrict, suspend or revoke the notification, taking into account the extent to which those requirements have not been met or where those obligations are not met; has 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 when the notified body cees its activity, the notified body concerned by the amendment to the notification shall transmit the files to the notified body. further processing to another notified body and shall ensure that they are kept ready for the notifying authority and the market surveillance authority at their request.

Challenging the competence of notified bodies

§ 24. (1) The Federal Minister for Science, Research and the Economy gives the European Commission the opportunity to investigate the cases in which it has the competence of a notified body. or the permanent fulfilment of the relevant requirements and obligations by a notified body, doubts or doubts, upon request, of any information on the basis of the notification or of the Maintaining 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 does not have the conditions for its notification. more than that. The Federal Minister for Science, Research and the Economy, as the notifying authority, shall, if necessary, take corrective measures, including a withdrawal of notification, as a result of the European Commission's determination.

Obligations of notified bodies in relation to their work

§ 25. (1) The notified bodies shall carry out the conformity assessment in accordance with the conformity assessment procedures in accordance with 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, they must be so strict 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 laid down 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) If 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 comply with the requirements of the to take corrective action, 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 or certificates. To restrict, suspend, or withdraw authorisations.

Reporting Obligations of notified bodies

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

1.

Any denial, restriction, suspension, or withdrawal of a certificate or a Approval,

2.

All circumstances, the consequences for the scope or conditions of the notification

3.

Any requests for information about conformity assessment activities that they use from the market surveillance authority,

4.

at the request of which conformity assessment activities they are in the scope of their They have been notified and which other activities, including cross-border activities and subcontracting, have been carried out.

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

Co-ordinating the notified bodies

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

5. Section

Supervision of the Union market, control of products imported into the Union market, protection of the protection of the protection of the products concerned

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

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

Method of handling products that are associated with a risk

§ 29. (1) If 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 for domestic and commercial animals or goods, it shall 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 non-compliance is not restricted to the domestic market, it has to inform the Federal Minister for Science, Research and the Economy of this and has it for its part, shall inform the European Commission and the other Member States of the European Union of the results of the evaluation and of the measures to which the economic operator has been invited. The Federal Minister for Science, Research and the Economy announcites notifications from other Member States of the European Union about products with non-compliance of the Market Surveillance Authority in a suitable way.

(3) The economic operator shall ensure that any appropriate corrective action he takes shall extend to all the products concerned which he or she placed on the market in the European Union or on the Market provided.

(4) Within the period referred to in paragraph 1, the economic operator concerned shall not take any appropriate corrective measures, the market surveillance authority shall take all appropriate provisional measures to ensure that the To prohibit or restrict the product on the domestic market, to withdraw or to recall the product from the market. 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) The information referred to in paragraph 4 shall indicate all available information, in particular the data for the identification of the non-conforming product, the origin of the product, the nature of the alleged product, and the nature of the product. 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 meets the health or safety requirements of people or the protection of domestic and commercial animals or goods, or

2.

The harmonized standards where compliance with § 13 is subject to a presumption of conformity deficient.

(6) If another Member State has initiated the procedure, the Federal Minister for Science, Research and Economic Affairs shall inform the European Commission and the other Member States of the European Union without delay, any measures adopted and any further information on the non-compliance of the product and, if it does not agree with the notified national measure, its objections.

(7) Within three months of the receipt of the information referred to in paragraph 4, neither another Member State nor the European Commission shall raise an objection to a provisional measure by the Market Surveillance Authority, this measure is considered to be 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 that pose a risk

§ 30. (1) According to an assessment pursuant to Section 29 (1) of the Market Surveillance Authority, it is established that a product poses a risk to the health or safety of people or to the home. , although it is in conformity with this Regulation, it shall invite the economic operator concerned to take all appropriate measures to ensure that the product in question is taken into account in the case of the the placing on the market of this risk no longer has, or within one of the types of The risk of reasonable, reasonable time, which it may prescribe, is withdrawn or recalled.

(2) The economic operator shall ensure that the corrective measures it takes extend to all the products concerned which it has provided 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. Actions.

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-compliance in question if it has one of the following: the following cases:

1.

the CE marking was in violation of Art. 30 of Regulation (EC) No 765/2008 or § 17;

2.

The CE label was not attached;

3.

the special explosion protection tag  , the characteristics that refer to the device group and category and, if necessary, the other markings and information listed in Annex II Z 1.0.5 were not

4.

the identification number of the notified body-if this is in the production control stage -has been or has not been applied for non-compliance with § 17;

5.

The EU declaration of conformity or, if appropriate, the certificate of conformity is the product not attached;

6.

The EU declaration of conformity or the certificate of conformity was not properly

7.

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

8.

missing the information specified in Section 7 (7) or § 9 (3) is incorrect or incomplete;

9.

Another requirement in accordance with § 7 or § 9 is not satisfied.

(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: to ensure that it is recalled or withdrawn from the market.

6. Section

Transitional and Final Provisions

Transitional provisions

§ 32. (1) The Market Surveillance Authority shall not prevent products from being provided on the market or 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.

(2) Certificates issued pursuant to Directive 94 /9/EC shall remain valid under 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. As far as personal names are given in masculine form in this Regulation, they refer to women and men in the same way. The gender-specific form is to be used in the application to specific persons.

Mitterlehner

ANNEX I

Decision criteria for division of device groups into categories

Essential Requirements

1. General requirements

1.

Device Group I

a)

The device category M 1 includes devices that are designed to be constructive and, if necessary, in addition to special protective measures, they may be operated in accordance with the characteristics indicated by the manufacturer and ensure a very high level of safety. 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

at least one second independent apparative when failure of an apparatus protection measure Protection measure to ensure the required security or

will ensure the required security when two independent errors occur.

The devices in this category must meet the more stringent requirements set out in Annex II Z 2.0.1.

)

The device category M 2 includes devices that are designed to be designed in a way that is Compliance with the parameters specified by the manufacturer can be operated and 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 must comply with the more stringent requirements of Annex II Z 2.0.2.

2.

Device Group II

a)

The device category 1 includes devices that are designed to be designed in a way that they can be used in Compliance with the parameters specified by the manufacturer can be operated and 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. Devices of this category must ensure the necessary level of safety even in the case of rarely occurring equipment disruptions and therefore have explosion protection measures, so that

at least one second independent apparative when failure of an apparatus protection measure Protection measure to ensure the required security or

will ensure the required security when two independent errors occur.

The devices in this category must meet the more stringent requirements of Annex II Z 2.1.

)

The device category 2 includes devices that are structurally designed to be in Compliance with the parameters specified by the manufacturer can be operated and ensure a high degree 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 requirements of Annex II Z 2.2.

)

The device category 3 includes devices that are structurally designed to be in Conformity with the parameters specified by the manufacturer can be operated and guarantee a normal degree 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 requirements of 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

The technical knowledge level, which changes quickly, must be immediately and as far as possible are applied.

For related devices according to § 2 paragraph 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 regard to the risk of explosion.

1.

Common Requirements for Devices and Protection Systems

1.0.

General requirements

1.0.1.

Principles of integrated explosion security

The design of devices and protective systems intended for use in potentially explosive atmospheres must be based on the principles of the integrated Explosion safety. To this end, the manufacturer must take measures to:

-

as a priority when it is possible to avoid explosive atmospheres that are from the devices and protection systems themselves can be created or released;

-

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

-

if there is an explosion that is a threat to people, and may, where appropriate, be caused by direct or indirect exposure to domestic and livestock animals or goods, to stop them immediately and/or to the range of explosion flames and explosion pressures to a sufficiently safe level.

1.0.2.

Devices and protective systems are designed to look at possible fault conditions, and in order to eliminate dangerous situations as far as possible.

The consideration is also to include reasonably foreseeable abuse.

1.0.3.

Special test and maintenance conditions

Devices and protective systems that are subject to special testing and maintenance conditions must be designed and built in accordance with these conditions.

1.0.4.

Environment conditions

Devices and protective systems must be designed and built with respect to existing or predictable environmental conditions.

1.0.5.

Labeling

The following minimum information must be displayed clearly and permanently on each device and protection system:

-

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

-

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

-

Name of the series and type,

-

optionally the batch or serial number,

-

the year of construction,

-

the special explosion protection tag  , followed by the tag that points to the device group and category,

-

for the device group II of the letter "G" (for areas where explosive gas, steam, Fog, air mixtures are present) and/or

-

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

1.0.6.

Operations Manual

a)

There must be an operating manual for each device or protection system, the following Minimum information contains:

The same information as for devices or protection systems (see Z 1.0.5) with The exception of the batch or serial number and, where applicable, maintenance-related information (e.g.  B. Addresses of service workshops, etc.);

Information about the or the secure

-

Start-up,

-

Usage,

-

Assembly and Disassembly,

-

Maintenance (maintenance and fault removal),

-

Rüsten;

-

where necessary to mark areas at risk Pressure relief devices;

-

If necessary, information about the incorporation;

-

Evidence that allows the decision to decide whether or not to use a device (corresponding to its designated category) or a protection system in the intended area under the conditions to be expected to be safely carried out;

-

Electrical characteristics and pressures, highest surface temperatures, and other limits;

-

If necessary, special conditions for use, including references to improper use, which can be experienced by experience;

-

If necessary, the basic features of the tools that are attached to the device or protection system

)

The operating manual includes those for commissioning, maintenance, inspection, Verification of the functionality and, where appropriate, repair of the equipment or protective system necessary plans and schemes and all relevant information, in particular with regard to safety.

)

With respect to security considerations, the documents in which the device or protection system is not in contradiction with the operating instructions.

1.1.

Selection of Materials

1.1.1.

Materials used for the construction of the devices and protective systems may be Taking into account operationally foreseeable strains does not cause the triggering of an explosion.

1.1.2.

No reactions within the manufacturer's foreseeable operating limits of the materials used with the components forming the explosive atmosphere, which can lead to an impairment of explosion safety.

1.1.3.

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

1.2.

Construction and construction

1.2.1.

Devices and protective systems are available in consideration of the technical knowledge to design and manufacture the explosion protection area in such a way that they can be operated safely during their expected lifetime.

1.2.2.

Components that are intended to be installed in devices and protective systems or as spare parts are design and manufacture in such a way that they are functionally reliable in terms of explosion protection if they are installed in accordance with the manufacturer's instructions.

1.2.3.

Closed design and prevention of leaks

For devices from which flammable gases or dusts can exit, the closed design should be as possible.

As far as possible, devices that have openings or leaks may not allow gases or dust to escape, so that outside the Devices cannot form an explosive atmosphere.

places where substances are entered or removed must, as far as possible, be designed and equipped in such a way as to ensure that no filling or emptying of the material is required. flammable substances.

1.2.4.

Dust Deposits

Devices and protective systems designed to be used in dust-loaded areas are to be designed in such a way as to ensure that dust deposits on their Do not ignite surfaces.

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

The surface temperatures of the appliance parts must be significantly below the glow temperatures of the stored dust.

The layer thickness of the deposited dust should be considered in terms of thermal insulation and, if necessary, due to temperature limitation.

1.2.5.

Additional protections

Devices and protective systems that may be exposed to external loads of a special nature must, if necessary, be accompanied by additional protective measures

The devices must be able to withstand the appropriate loads without affecting explosion protection.

1.2.6.

Dangerous Opening

If devices and protective systems are arranged in a housing or under closure that are part of the explosion protection itself, it may only be used by means of of a special tool or of appropriate protective measures, to open it.

1.2.7.

Protection against other risks

Devices and protection systems must be designed and manufactured in such a way that

a)

Avoiding injury or other damage caused by direct or indirect contact could be caused;

)

It is ensured that there are no dangerous surface temperatures on accessible device parts or dangerous radiations;

)

Non-electrical hazards that occur in the experience are excluded;

)

It is ensured that predictable overload states do not have dangerous situations

The risks referred to in this Z, which originate from devices and protection systems, are wholly or partially covered by other European Union law , the present Regulation shall not apply to such equipment and protective systems and to those risks, 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 overloading

Dangerous overload of devices is already in development with integrated devices for measurement, control and control technology. in particular with overcurrent triggers, temperature limiters, differential pressure switches, flow monitors, time relay, speed monitors and/or related monitoring devices.

1.2.9.

Pressure-proof encapsulation devices

If parts that can ignite an explosive atmosphere are enclosed in a housing, then make sure that the enclosure is the one in the explosion of an explosive mixture in the interior, and a transfer of the explosion to the explosive atmosphere surrounding the housing is prevented.

1.3.

Potential ignition sources

1.3.1.

Hazards of different ignition source types

sparks, flames, arcs, high surface temperatures, sound energy, optical radiation, electromagnetic waves, and other Ignition source types with ignitable potential must not be created.

1.3.2.

Hazards of static electricity

Electrostatic charges that can lead to hazardous discharge operations must be avoided by appropriate measures.

1.3.3.

Hazards caused by electrical stray and leakage

Electrical stray and leakage currents in conductive device parts, for example, to create ignitable sparks, overheating of surfaces, or dangerous corrosion, must be prevented.

1.3.4.

Intolerable warming hazards

Inadmissible heating that is caused by rubbing and beating, for example.  For example, between materials, rotating parts or the penetration of foreign bodies, they should be avoided as far as possible in a constructive way.

1.3.5.

Hazards for pressure balancing

Devices and protective systems must be designed or equipped with integrated devices for measurement, control and control technology to ensure that they are Do not generate shock waves or compressions that can cause an explosion.

1.4.

Hazards due to external interference effects

1.4.1.

The devices and protection systems must be designed and built in such a way that they are also changing environmental conditions, under the influence of external stresses, in the event of moisture exposure, vibration, pollution and other external influences within the limits of the operating conditions specified by the manufacturer Perform the intended function safely.

1.4.2.

Device parts must be appropriate to the mechanical and thermal stresses that are provided to be able to withstand the effects of existing or foreseeable aggressive substances.

1.5.

Security Devices Requirements

1.5.1.

Safety devices must be independent of operating measurement and/or Control devices work.

As far as possible, the failure of a security device must be detected quickly enough by appropriate technical measures, so that dangerous states with high probability of not entering.

The principle of failsafe behavior is to be applied.

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

1.5.2.

As far as possible, the device and/or protection system must be in the event of failure of safety devices. into a safe state.

1.5.3.

Safety devices emergency exits must, as far as possible, relock . 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

Where operating and display devices are used, they shall be designed to be ergonomic in terms of explosion risk, in order to: To achieve the highest level of operational security.

1.5.5.

Requirements for devices with a measurement function for explosion protection

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

1.5.6.

The display accuracy and operability of devices with a measurement function must be Need to be checked.

1.5.7.

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

1.5.8.

Risk through software

When designing devices, protective systems, and security devices that are software-controlled, the risks must be particularly affected by errors in the program.

1.6.

Integration of security-related system requirements

1.6.1.

Devices and protective systems that are running in automatic operation and that are operated by the intended operation , you must be able to shut down manually if this does not affect security.

1.6.2.

Saved energies must be so fast when you are operating the emergency shutdown devices to be isolated as safely as possible, so that they lose their driving effect.

This does not apply to electrochemically stored energies.

1.6.3.

Power failure hazards

For devices and protection systems where an energy failure can lead to additional risks, a secure system must be independent of the rest of the operating system. Maintain the operating state.

1.6.4.

hazards due to ports

Devices and protective systems must be equipped with appropriate cables and wires.

Devices and protection systems intended to be used in conjunction with other devices or protective systems must be used in the Interfaces are secure.

1.6.5.

Order of warning devices as part of a device

If devices or protective systems are equipped with detector or warning devices to indicate the occurrence of explosive atmospheres, data , which will enable the equipment to be installed in a suitable way.

2.

More requests to devices

2.0.

Device Group I device requests

2.0.1.

Device Category M 1 Requirements of Device Group I

2.0.1.1.

The devices must be designed and manufactured in such a way that ignition sources themselves are Rare device failures do not take effect.

You must be equipped with explosion protection measures, so that

at least one second independent apparative when failure of an apparatus protection measure Protection measure to ensure the required security or

-

ensuring the required level of security when two independent errors occur .

As far as required, the devices must also be provided with special protection measures.

You must be able to continue operating when an explosive atmosphere is present.

2.0.1.2.

The devices must be built in such a way that dust does not penetrate into them, if necessary

2.0.1.3.

The surface temperatures of the device parts must be limited to the non-ignition of Swirled dust is clearly below the ignition temperature of foreseeable dust/air mixtures.

2.0.1.4.

The devices must be designed so that the opening of device parts that are ignition sources , can only be possible in an energy-free or intrinsi-safe condition. If a device cannot be deactivated, the manufacturer must issue a warning to the device parts that can be opened.

As far as required, the devices must be equipped with appropriate additional locking mechanisms.

2.0.2.

Device Category M 2 Requirements of Device Group I

2.0.2.1.

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

When an explosive atmosphere occurs, the devices must be shut down.

2.0.2.2.

The devices must be designed so that the opening of device parts that are ignition sources , can only be possible in an energy-free state or via corresponding locking systems. If a device cannot be deactivated, the manufacturer must issue a warning to the device parts that can be opened.

2.0.2.3.

With regard to dust explosion protection, the requirements of device category M 1

2.1.

Device category 1 requirements of device group II

2.1.1.

Explosive atmospheres caused by gases, vapours, or fog

2.1.1.1.

The devices are to be designed and manufactured in such a way that sources of ignition are rare

You must be equipped with explosion protection measures, so that

at least one second independent apparative when failure of an apparatus protection measure Protection measure to ensure the required security or

-

ensuring the required level of security when two independent errors occur .

2.1.1.2.

For devices whose surfaces can heat up, ensure that the the highest surface temperatures are not exceeded even in the worst case scenario.

There are also temperature increases due to heat stout and chemical reactions.

2.1.1.3.

The devices must be designed so that the opening of device parts that are ignition sources , can only be possible in an energy-free or intrinsi-safe condition. If a device cannot be deactivated, the manufacturer must issue a warning to the device parts that can be opened.

As far as required, the devices must be equipped with appropriate additional locking mechanisms.

2.1.2.

Explosionable atmosphere by dust/air mixtures

2.1.2.1.

The devices are to be designed and manufactured in such a way that an inflammation of Dust/air mixtures are avoided even in the case of seldom occurring equipment failures.

You must be equipped with explosion protection measures, so that

at least one second independent apparative when failure of an apparatus protection measure Protection measure to ensure the required security or

-

ensuring the required level of security when two independent errors occur .

2.1.2.2.

As far as required, the devices must be built in such a way that dust only applies to the be able to penetrate them or leave them.

The intended insertion and attachment parts must also satisfy this requirement.

2.1.2.3.

The surface temperatures of the device parts must be limited to the non-ignition of Swirled dust is clearly below the ignition temperature of foreseeable dust/air mixtures.

2.1.2.4.

With regard to the safe opening of the devices, the relevant requirement applies 2.1.1.3.

2.2.

Device Category 2 Requirements of Device Group II

2.2.1.

Explosive atmospheres caused by gases, vapours, or fog

2.2.1.1.

The devices must be designed and manufactured in such a way that even when they occur frequently Device faults or incorrect operating conditions, which usually have to be expected, ignition sources are avoided.

2.2.1.2.

With regard to surface temperatures, the device parts are to be designed and , that they will not be exceeded even in the case of unusual operating situations provided by the manufacturer.

2.2.1.3.

The devices must be designed so that the opening of device parts that are ignition sources , can only be possible in an energy-free state or via corresponding locking systems. If a device cannot be deactivated, the manufacturer must issue a warning to the device parts that can be opened.

.

Explosionable atmosphere through dust/air mixtures

2.2.2.1.

The devices are to be designed and manufactured in such a way that it is even in the case of frequent occurrence Equipment faults or fault conditions, which usually have to be expected, cannot be used for the ignition of dust/air mixtures.

2.2.2.2.

With regard to surface temperatures, requirement 2.1.2.3.

2.2.2.3.

With regard to dust protection, the requirement 2.1.2.2 applies.

2.2.2.4.

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

2.3.

Device category 3 requirements of device group II

2.3.1.

Explosive atmospheres caused by gases, vapours, or fog

2.3.1.1.

The devices are to be designed and manufactured in such a way that predictably expected Ignition sources that can occur during normal operation are avoided.

2.3.1.2.

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

2.3.2.

Explosionable atmosphere by dust/air mixtures

2.3.2.1.

The devices are to be designed and manufactured in such a way that dust/air mixtures of Do not ignite the ignition sources to be expected in operation.

2.3.2.2.

With regard to surface temperatures, requirement 2.1.2.3.

2.3.2.3.

The devices, including the intended insertion and connection parts, must be at The size of the dust particles shall be taken into account in such a way that neither explosive dust/air mixtures nor dangerous dust accumulations can be formed inside the dust.

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 on are limited to a sufficient degree.

3.0.2.

The protection systems must be designed and organized in such a way that: Explosion transmission by dangerous chain reactions and flame jet detonations as well as transitions from ongoing explosions in detonations are prevented.

3.0.3.

In the event of a failure of the power supply, the protection systems must be over a reasonable period of time. maintain their ability to function in order to avoid dangerous situations.

3.0.4.

Protection systems are not allowed to fail under the influence of external interference effects.

3.1.

Project planning and planning

3.1.1.

Material properties

When designing the material properties, the expected explosion pressure, taking into account extreme operating conditions, is the maximum Explosion pressure as well as the expected heat effect of the flame must be taken into account.

3.1.2.

Protection systems that are used to back or undercontrol explosions must be in Be able to withstand pressure surges without losing their system integrity.

3.1.3.

The fittings connected to the protection systems must be the maximum expected Explosion pressure withstands without losing its functionality.

3.1.4.

The expected pressure ratios in peripheral devices and connected pipe sections shall be taken into account for their retroactive effect in the planning and project planning phase of the explosion protection systems.

3.1.5.

Discharge devices

If you expect the protective systems used to be stressed beyond their material strength, appropriate relief devices are available in in a non-dangerous way for people who are present in the immediate vicinity.

3.1.6.

Explosionsuppression Systems

Explosion suppression systems must be designed and projected in such a way that, in the event of an event, they are likely to explode at an earliest possible time. and to optimally counteract it, taking into account the maximum pressure increase in time and the maximum explosion pressure.

3.1.7.

Explosionary decoupling systems

Uncoupling systems designed to remove specific devices 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 the mechanical load-bearing capacity under conditions of use.

3.1.8.

The protection systems must be integrated into a circuit-oriented concept with appropriate An alarm threshold can be integrated so that, if necessary, a switch-off of the product supply and removal and of the equipment parts which no longer ensure a safe operation is carried out.

ANNEX III

Module B: EU Type Check

1.

The EU type-examination is the part of a conformity assessment procedure, where a notified body examines and certifies the technical design of a product, and certifies that it satisfies the requirements of this Regulation applicable to the product.

2.

The EU type-examination will be representative of a planned production Full product pattern (construction pattern) performed.

3.

The application for EU type-examination is from the manufacturer to a single notified body. of his choice.

The application contains the following:

a)

The name and address of the manufacturer and, if the application is submitted by the plenipotentiary, also its name and address;

b)

a written declaration that the same application does not apply to any other notified body. ;

)

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)

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

iii)

Descriptions and explanations to understand the drawings and plans mentioned above as well as how the product works,

)

a list of harmonised standards, the references of which are published in the Official Journal of the The European Union has been published, fully or in part, and, if these harmonized standards have not been applied, a description of the solutions to the essential health and safety requirements. this Regulation has been complied with, including a list, 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.

)

the results of design calculations, checks, and so on, and

vi)

the audit reports

)

representative samples for the production in question. The notified body can request additional samples if necessary to complete the validator.

4.

The notified body has the following tasks:

4.1.

Review of the technical documentation, check whether the pattern or patterns are in accordance with the the technical documentation has been manufactured and the parts are drawn up in accordance with the relevant harmonised standards and which parts are 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 opted for their application;

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 the 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 investigations and checks are performed.

5.

The notified body creates an audit report on the z 4 Measures and the results achieved. 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.

The design pattern corresponds to the requirements of the product in question for the product concerned. Regulation shall issue the notified body to 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 contain all the relevant information to ensure that the products manufactured are in conformity with assess the design and, if necessary, carry out any checks after they have been put into service.

The construction pattern does not deny the applicable requirements of this Regulation the notified body refuses to issue a EU type-examination certificate and shall inform the applicant of this, giving a detailed explanation of its refusal.

7.

The notified body is continuously informed of any changes in the generally accepted State of the art; if they indicate that the approved model no longer complies with the applicable requirements of this Regulation, it shall decide whether any such changes will require further investigation. If this is the case, the notified body shall inform the manufacturer thereof.

The manufacturer shall inform the notified body that is in the technical documentation of the EU type-examination certificate of any changes to the certificate. any approved type which could affect its conformity with the essential health and safety requirements of this Regulation or the conditions for the validity of that certificate. Such changes require an additional permit in the form of a supplement 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 they have been issued or withdrawn, and shall transmit to their notifying authority, at regular intervals or on request, a list of all such certificates. and/or additions to which they are refused, suspended or otherwise restricted .

Each notified body shall inform the other notified bodies of the EU type-examination certificates and/or any additions they may have made to them. , refused, withdrawn, suspended or otherwise restricted, and, if requested to do so, shall inform them of any such certificates and/or additions issued by it.

If you ask for this, the European Commission, the Member States and the other notified bodies will receive a copy of the EU type-examination certificates and/or their supplements. 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 holds a copy of the EU type-examination certificate together with attachments and additions. together with the technical documentation, ready for 10 years after placing the product on the market for the market surveillance authority.

10.

The authorized representative of the manufacturer may submit the application referred to in Z 3, and the Z 7 and 9 shall be fulfilled if they are defined on behalf of the contract.

ANNEX IV

Module D: Conformance to the pattern based on a quality assurance related to the production process

1.

In compliance with the construction pattern, based on a quality assurance based on the The production process 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 declares on its own responsibility that the products in question are the type of construction described in the EU type-examination certificate, and fulfil the requirements of this Regulation applicable to them.

2.

Manufacturing

The manufacturer operates an approved quality assurance system for the manufacture, final acceptance and testing of the products in question according to Z 3 and is subject to surveillance in accordance with Z 4.

3.

Quality assurance system

3.1.

The manufacturer requests a notified body of his choice to evaluate his or her choice. Quality assurance systems for the products concerned.

The application contains the following:

a)

The name and address of the manufacturer and, if the application is submitted by the plenipotentiary, also its name and address;

b)

a written declaration that the same application does not apply to any other notified body. ;

)

All relevant information about the intended product category;

d)

The documentation of the quality assurance system;

e)

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

3.2.

The quality assurance system ensures that the products match the one in the EU type-examination certificate and with the requirements of this Regulation applicable to them.

All elements, requirements, and regulations taken into account by the manufacturer are systematically and correctly written in the form of written principles, procedures and instructions. These quality assurance documents must enable a uniform interpretation of the quality assurance programmes, plans, manuals and reports.

In particular, you have an appropriate description of the following points:

a)

Quality objectives and organizational structure, responsibilities, and powers of the Executive management in terms of product quality;

)

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

)

Before, during, and after manufacture, tests and tests their frequency;

)

The quality-relevant records, such as audit reports and audit data, calibration data, Reports on the qualifications of the staff working in this area, etc.; and

e)

means to achieve the required product quality and to work effectively of the quality assurance system.

3.3.

The notified body evaluates the quality assurance system to determine whether it is in Z 3.2 requirements are met.

For each component of the quality assurance system that meets the relevant specifications of the relevant harmonised standard, it goes from a Compliance with these requirements.

In addition to experience with quality management systems, at least one member of the audit team has experience with the assessment in the relevant the product range and product technology concerned, and knowledge of the applicable 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 of these requirements.

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

.

The manufacturer undertakes to use the approved quality assurance system and to ensure that it is always properly and effectively kept.

3.5.

The manufacturer shall inform the notified body that the quality assurance system , all scheduled changes to the quality assurance system.

The notified body assesses all planned changes and decides whether the modified quality assurance system is still the same as the one mentioned in Z 3.2. Requirements or whether a reassessment is required.

You are announcting your decision to the manufacturer. The notification must include the conclusion of the assessment and the justification for the assessment decision.

4.

Monitoring under the responsibility of the notified body

4.1.

Monitoring is designed to ensure that the manufacturer has the obligations under the approved Quality assurance system in compliance with the rules.

4.2.

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

a)

The documentation of the quality assurance system;

)

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

4.3.

The notified body periodically carries out audits to ensure that the manufacturer maintains and applies the quality assurance system, and submits a corresponding audit report to it.

4.4.

In addition, the notified body can see 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 case of a test, a test report.

5.

CE Marking, EU Declaration of Conformity, and Conformity Certificate

5.1.

The manufacturer will bring to each individual product that is not a component and the one with the of the EU type-examination certificate, which complies with the applicable requirements, the CE marking and, under the responsibility of the notified body referred to in Z 3.1, its identification number.

5.2.

The manufacturer provides a written record for each product model that is not a component. EU declaration of conformity, and shall keep it ready for market surveillance authorities for 10 years after the product is placed on the market, which is not part of the product. 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 must provide a written certificate of conformity for each component model and, after placing the component on the market for the market surveillance authorities, shall be ready for ten years. The certificate of conformity must show the component model for which it has been issued. A copy of the certificate of conformity is attached to each component.

6.

The manufacturer holds the product for 10 years after placing the product on the market. Market surveillance authorities provide the following documents:

a)

The documents according to Z 3.1;

)

the information in relation to the change according to Z 3.5 in its approved form;

)

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 the 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 it refuses, suspended or restricted in some other way.

Each notified body shall be informed by the other notified bodies of the approval of quality assurance systems that they are refusing to notify, has been withdrawn or otherwise restricted, and at the request of the certification of quality assurance systems which it has granted.

8.

Plenipotentiary

The manufacturer's obligations under Z 3.1, 3.5, 5, and 6 may be fulfilled by his authorized representative on his behalf and under his responsibility if they are set on the work order.

ANNEX V

Module F: Compliance with the Construction Pattern based on a Product Review

1.

Conformance with the construction pattern on the basis of a test of the products the part of a conformity assessment procedure in which the manufacturer fulfils the obligations laid down in Z 2 and 5 and ensures, on its own responsibility, that the affected persons subject to the provisions of Z 3 Products conforming to the type of construction described in the EU type-examination certificate and comply with the requirements of this Regulation applicable to them.

2.

Manufacturing

The manufacturer must take all the necessary measures to ensure that the manufacturing process and its monitoring ensure that the products manufactured are consistent with the type of type described in the EU type-examination certificate and with the requirements of this Regulation applicable to them.

3.

Review

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

The examinations and tests to check the conformity of the products with the appropriate requirements will be carried out by examination and testing of each individual product according to Z 4.

4.

Review of compliance by examining and checking each product

4.1.

All products are examined individually, and the appropriate checks are performed after the relevant harmonised standard (s) and/or equivalent tests, as set out in other relevant technical specifications. , in order to verify their conformity with the approved type of design 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 decides which checks are to be performed.

4.2.

The notified body provides a basis for these examinations and tests. certificate of conformity and shall affix its identification number to any approved product or allow it to be brought under its responsibility.

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

5.

CE Marking, EU Declaration of Conformity, and Conformity Certificate

5.1.

The manufacturer will bring to each individual product that is not a component and the one with the approved in the EU type-examination certificate and which complies with the applicable requirements of this Regulation, the CE marking and, under the responsibility of the notified body referred to in Z 3, the Identification number.

5.2.

The manufacturer provides a written record for each product model that is not a component. EU declaration of conformity, and shall keep it ready for market surveillance authorities for 10 years after the product is placed on the market, which is not part of the product. 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.

If the notified body referred to in Z 3 is correct, the manufacturer may, under the responsibility of this notified body, also be able to identify the identification number of the The notified body must be notified to the products that are not components.

5.3.

The manufacturer must provide a written certificate of conformity for each component model and, after placing the component on the market for the market surveillance authorities, shall be ready for ten years. The certificate of conformity must show the component model for which it has been issued. A copy of the certificate of conformity is attached to each component.

6.

If the notified body is correct, the manufacturer can be under the responsibility of the The notified body shall attach the identification number of the notified body to the products during the manufacturing process.

7.

Plenipotentiary

The obligations of the manufacturer may be fulfilled by his authorized representative on his behalf and under his responsibility, provided that they are on behalf of the shall be established. An authorized representative shall not be entitled to fulfil the obligations of the manufacturer set out in Z 2.

ANNEX VI

Module C1: Conformance to the building pattern based on an internal production control with monitored product checks

1.

In compliance with the construction pattern, based on an internal manufacturing control with the product tests monitored shall be the part of a conformity assessment procedure in which the manufacturer fulfils the obligations laid down in z 2, 3 and 4 and ensures and declares on his own responsibility that the relevant Products of the type described in the EU type-examination certificate and comply with the requirements of Part 2 of this Regulation which apply to them.

2.

Manufacturing

The manufacturer must take all the necessary measures to ensure that the manufacturing process and its monitoring ensure that the products manufactured are consistent with the type of type described in the EU type-examination certificate and with the requirements of this Regulation applicable to them.

3.

Product checks

One or more tests of one or more specific aspects of the product are manufactured by the manufacturer or by his or her behalf. shall be carried out in order to verify compliance with the type of construction described in the EU type-examination certificate and with the relevant requirements of this Regulation. These tests shall be carried out under the responsibility of a notified body chosen by the manufacturer.

The manufacturer will bring the identification number of this location under the responsibility of the notified body during the manufacturing process.

4.

CE Marking, EU Declaration of Conformity, and Conformity Certificate

4.1.

The manufacturer brings to each individual product that is not a component, and the one with the of the EU type-examination certificate, which complies with the applicable requirements of this Regulation, the CE marking.

4.2.

The manufacturer is writing a written product model that is not a component EU declaration of conformity, and shall keep it ready for market surveillance authorities for 10 years after the product is placed on the market, which is not part of the product. 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 must provide a written certificate of conformity for each component model and, after placing the component on the market for the market surveillance authorities, shall be ready for ten years. The certificate of conformity must show the component model for which it has been issued. A copy of the certificate of conformity is attached to each component.

5.

Plenipotentiary

The manufacturer's obligations under Z 4 may be fulfilled by his authorized representative on his behalf and under his responsibility, if they are set on the work order.

ANNEX VII

Module E: Conformance to the design based on quality assurance based on the product

1.

Conformance with the construction pattern based on a quality assurance based on the The product is the part of a conformity assessment procedure in which the manufacturer fulfils the obligations laid down in z 2 and 5 and ensures and declares on its own responsibility that the products concerned shall comply with the obligations laid down in the EU type-examination certificate shall correspond to the type of design described above and shall be applicable to the Meet the requirements of this Regulation.

2.

Manufacturing

The manufacturer operates an approved quality assurance system for the final acceptance and testing of the products concerned in accordance with Z 3 and is subject to the Monitoring according to Z 4.

3.

Quality assurance system

3.1.

The manufacturer requests a notified body of his choice to evaluate his or her choice. Quality assurance systems for the products concerned.

The application contains the following:

a)

The name and address of the manufacturer and, if the application is submitted by the plenipotentiary, also its name and address,

b)

a written declaration that the same application does not apply to any other notified body. ;

)

All relevant information about the intended product category,

d)

the quality assurance system and

e)

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

3.2.

The quality assurance system ensures that the products match the one in the EU type-examination certificate and with the requirements of this Regulation applicable to them.

All elements, requirements, and regulations taken into account by the manufacturer are systematically and correctly written in the form of written principles, procedures and instructions. These quality assurance documents must enable a uniform interpretation of the quality assurance programmes, plans, manuals and reports.

In particular, you have an appropriate description of the following points:

a)

Quality objectives and organizational structure, responsibilities, and powers of the Executive management in terms of product quality;

)

Investigations and checks performed after manufacture;

)

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

)

Medium that monitors the effective operation of the quality assurance system.

3.3.

The notified body evaluates the quality assurance system to determine whether it is in Z 3.2 requirements are met.

For each component of the quality assurance system that meets the relevant specifications of the relevant harmonised standard, it goes from a Compliance with these requirements.

In addition to experience with quality management systems, at least one member of the audit team has experience with the assessment in the relevant the product range and product technology concerned, and knowledge of the applicable 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 of these requirements.

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

.

The manufacturer undertakes to use the approved quality assurance system and to ensure that it is always properly and effectively kept.

3.5.

The manufacturer shall inform the notified body that the quality assurance system , all scheduled changes to the quality assurance system.

The notified body assesses all planned changes and decides whether the modified quality assurance system is still the same as the one mentioned in Z 3.2. Requirements or whether a reassessment is required.

You are announcting your decision to the manufacturer. The notification must include the conclusion of the assessment and the justification for the assessment decision.

4.

Monitoring under the responsibility of the notified body

4.1.

Monitoring is designed to ensure that the manufacturer has the obligations under the approved Quality assurance system in compliance with the rules.

4.2.

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

a)

the documentation of the quality assurance system

)

The quality-relevant records, such as audit reports and audit data, calibration data, Reports on the qualifications of the personnel involved in this area, etc.

4.3.

The notified body periodically carries out audits to ensure that the manufacturer maintains and applies the quality assurance system, and submits a corresponding audit report to it.

4.4.

In addition, the notified body can see 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 case of a test, a test report.

5.

CE Marking, EU Declaration of Conformity, and Conformity Certificate

5.1.

The manufacturer will bring to each individual product that is not a component and the one with the of the EU type-examination certificate, which complies with the applicable requirements, the CE marking and, under the responsibility of the notified body referred to in Z 3.1, its identification number.

5.2.

The manufacturer provides a written record for each product model that is not a component. EU declaration of conformity, and shall keep it ready for market surveillance authorities for 10 years after the product is placed on the market, which is not part of the product. 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 must provide a written certificate of conformity for each component model and, after placing the component on the market for the market surveillance authorities, shall be ready for ten years. The certificate of conformity must show the component model for which it has been issued. A copy of the certificate of conformity is attached to each component.

6.

The manufacturer holds the product for 10 years after placing the product on the market. Market surveillance authorities provide the following documents:

a)

The documents according to Z 3.1;

)

the information in relation to the change according to Z 3.5 in its approved form;

)

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 the 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 it refuses, suspended or restricted in some other way.

Each notified body shall inform the other notified bodies of authorisations of quality assurance systems that they refuse to notify, or , and at the request of approvals of quality assurance systems that it has granted.

8.

Plenipotentiary

The manufacturer's obligations under Z 3.1, 3.5, 5, and 6 may be fulfilled by his authorized representative on his behalf and under his responsibility if they are set on the work order.

ANNEX VIII

Module A: Internal Manufacturing Control

1.

The internal manufacturing control is the conformity assessment procedure, with the manufacturer fulfils the obligations set out in Z 2, 3 and 4, and ensures and declares on its own responsibility that the products concerned satisfy the requirements of this Regulation applicable to them.

2.

Technical documents

The manufacturer creates the technical documentation. These documents shall make it possible to assess the conformity of the product with the requirements in question; they must include a suitable risk analysis and assessment.

The technical documentation shall list the applicable requirements and collect the design, manufacture and functioning of the product, in so far as they are relevant to the assessment. The technical documentation shall contain at least the following elements:

a)

a general description of the product,

)

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

)

Descriptions and explanations that are used to understand the drawings and plans mentioned above, and the functionality of the product is required

)

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

e)

the results of design calculations, checks, etc., and

f)

the audit reports.

3.

Manufacturing

The manufacturer must take all the necessary measures to ensure that the manufacturing process and its monitoring match the products with those in Z 2. , and with the requirements of this Regulation applicable to them.

4.

CE Marking, EU Declaration of Conformity, and Conformity Certificate

4.1.

The manufacturer will bring to each individual product that is not a component and that the the applicable requirements of this Regulation, the CE marking.

4.2.

The manufacturer is writing a written product model that is not a component EU declaration of conformity and, together with the technical documentation, shall provide it for the market surveillance authorities for 10 years after placing the product on the market, which is not a component. The EU declaration of conformity must show which product model, 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 must provide a written certificate of conformity for each component model and, together with the technical documentation, shall make it available to the market surveillance authorities for 10 years after the component has been placed on the market. The certificate of conformity must show the component for which it was issued. A copy of the certificate of conformity is attached to each component.

5.

Plenipotentiary

The manufacturer's obligations under Z 4 may be fulfilled by his authorized representative on his behalf and under his responsibility, if they are set on the work order.

ANNEX IX

Module G: Compliance based on a single audit

1.

The compliance on the basis of a single audit is 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 shall be subject to the requirements of the applicable law. Requirements of this Regulation.

2.

Technical documents

2.1.

The manufacturer creates the documents and places them in the notified body referred to in Z 4. is available. 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,

)

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

)

Descriptions and explanations that are used to understand the drawings and plans mentioned above, and the functionality of the product is required

)

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

e)

the results of design calculations, checks, etc., and

f)

the audit reports.

2.2.

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

3.

Manufacturing

The manufacturer shall take all the necessary measures to ensure that the manufacturing process and its monitoring ensure the conformity of the manufactured products with the shall ensure 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 are 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 provides a certificate of conformity on the basis of these tests and tests, and brings it to each approved product their identification number, or let them be brought under their responsibility.

The manufacturer holds the compliance certificates for the market surveillance authorities for 10 years after the product is placed on the market.

5.

CE Marking, EU Declaration of Conformity, and Conformity Certificate

5.1.

The manufacturer will bring to each product that is not a component and that the applicable This Regulation meets the requirements of this Regulation, the CE marking and, under the responsibility of the notified body referred to in Z 4, its identification number.

5.2.

The manufacturer issues a written EU declaration of conformity and holds it for ten years long after placing the product on the market, which is not a component, for the market surveillance authorities. 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 must issue a written certificate of conformity and hold it for ten years long after the component has been placed on the market for market surveillance authorities. The certificate of conformity must show the component for which it was issued. A copy of the certificate of conformity is attached to each component.

6.

Plenipotentiary

The manufacturer's obligations in Z 2.2 and 5 may be fulfilled by his authorized representative on his behalf and under his responsibility, if they are set on the work order.

ANNEX X

EU Declaration of Conformity (NR) xxxx)

1.

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

2.

The name and address of the manufacturer and, where appropriate, its authorized representative:

3.

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

4.

The object of the declaration (label of the product for traceability: if necessary, if necessary) in order to identify the product, an image will be added.):

5.

The subject-matter of the statement described above meets the relevant Harmonisation legislation of the Union:

6.

Specification of the relevant harmonised standards or the other technical specifications that the declaration of conformity was based on the following:

7.

Where applicable: The notified body ... (name, identification number) ... (description of its (measure) ... and the following certificate issued:

8.

Additional information:

Undersigned for and on behalf of:

(location and date of the exhibition):

(name, function) (signature):