Explosion Protection Directive 2015 - 2015 Exsv

Original Language Title: Explosionsschutzverordnung 2015 – ExSV 2015

Read the untranslated law here: http://www.ris.bka.gv.at/Dokumente/BgblAuth/BGBLA_2016_II_52/BGBLA_2016_II_52.html

52. Regulation of the Federal Minister for science, research and economy of equipment and protective systems intended for use in potentially explosive atmospheres (explosion protection directive 2015 - 2015 ExSV)

On the basis of



1 of § 2 para 1 of the machines - placing - and NotifizierungsG - MING, Federal Law Gazette I no. 77/2015, and 2 of § 181 of the mineral raw material act - MinroG, Federal Law Gazette I no. 38/1999, as last amended by Federal Law Gazette I no. 80/2015, as well as 3 of § 3 para 4 and 6, section 7, paragraph 1, 5 and 6 and article 7 b of paragraph 7 of the electrical engineering Act 1992 - ETG 1992 , Federal Law Gazette No. 106/1993, amended by Federal Law Gazette I no. 129/2015, is prescribed: table of contents


1 section General provisions § 1 scope § 2. implementation § 3. definitions § 4. making available on the market and commissioning 5. essential health and safety requirements § 6 free movement of goods section 2 obligations of economic operators § 7 obligations of the manufacturer § 8 authorized § 9 obligations of importers § 10 obligations of dealers § 11 circumstances under which the obligations of the manufacturer apply to importers and distributors § 12 identification of economic operators 3. section conformity of the product article 13 presumption of conformity of products § 14 conformity assessment procedures § 15 EU Declaration of conformity § 16 general principles the CE marking § 17 rules and conditions for the affixing of the CE marking 4. section conformity assessment article 18 notification of conformity assessment bodies, information obligations of the notifying authority § 19 requirements on notified bodies § 20 presumption of conformity when notified points § 21 affiliates of notified bodies and subcontracting § 22 notification procedure § 23 changes to the notification section 24 challenge of the competence of notified bodies § 25 obligations of notified bodies in relation to their work § 26 reporting obligations of notified bodies § 27 coordination of notified bodies 5. section monitoring of the Union market , Control of the products introduced on the Union market, safeguard clause procedure § 28 Union market monitoring and control of the products concerned on the Union market § 29 procedure for the treatment of products that a risk is connected to § 30-compliant products that pose a risk to § 31 formal non-compliance 6 section transitional and final provisions § 32. transitional provisions § 33. entry into force of § 34. linguistic equal treatment annex I





Decision criteria for the classification of the device groups into categories







ANNEX II





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







ANNEX III





Module B: EC type examination







ANNEX IV





Module D: involved conformity with the design on the basis of a quality assurance on the production process







ANNEX V





Module F: conformity with the design on the basis of a product audit







ANNEX VI





Module C1: Conformity with the design on the basis of an internal production control plus supervised product testing







ANNEX VII





Module E: related conformity type on the basis of quality assurance to the product







ANNEX VIII





Module A: internal production control







ANNEX IX





Module g conformity based on a single audit







ANNEX X.





EU Declaration of conformity (No. xxxx)





 

1 section

General terms and conditions

Scope

§ 1 (1) this Regulation applies to the following "products" following equipment and protective systems, called:



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

2. safety, control and regulating devices for use outside potentially explosive atmospheres, which however with regard to explosion risks for the safe operation of equipment and protective systems are necessary or contribute;

3. components that are intended to be incorporated in the protective systems and devices referred to in subpara 1.

(2) this Regulation shall not apply:



1 medical devices intended for use in medical fields;

2. equipment and protective systems where the explosion hazard; caused exclusively by the presence of explosives or chemically unstable substances

3. devices that are intended for use in domestic and non-commercial environment, where can be made an explosive atmosphere as a result of accidental leakage of fuel only rarely and only;

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

5. seagoing vessels and mobile off-shore units, as well as the equipment on board these ships or installations;

6 means of transport, i.e. vehicles and accompanying trailers, which are intended exclusively for the carriage of persons in the air, road and rail networks or on water and means of transport, so far as they are designed for the transport of goods in the air, on public road and rail networks or on water. Vehicles to be used in potentially explosive atmospheres, are taken by the scope of this regulation;

7 products in accordance with article 346 para 1 lit. b of the Treaty on the functioning of the European Union, Federal Law Gazette III No. 86/1999 as amended by Federal Law Gazette III No. 314/2013.

Implementation

§ 2. Through this regulation, the directive is 2014/34/EC on the harmonisation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres OJ No. L 96 of the 29.3.2014 p. 309, transposed into Austrian law.

Definitions

§ 3. The purposes of this regulation, the term may refer to:



1. "Devices": machines, equipment, stationary or transportable devices, control and equipment parts and warning and prevention systems, which are individually or combined to the generation, transfer, storage, measurement, control and conversion of energy and/or intended for processing of materials and have their own potential ignition sources and thereby cause an explosion;

2. "Protective systems": all devices with the exception of components; provided by devices that should immediately stop explosions running to and/or limit the area affected by an explosion and as autonomous systems on the market separately

3. "Components": such devices, which are required for the safe operation of equipment and protective systems, without to meet even an autonomous function.

4. "explosive atmosphere": a mixture of air and combustible gases, vapours, mists or dusts under atmospheric conditions, in which, the combustion spreads to the entire unburned mixture after the inflammation;

5. "hazardous area": an area that will potentially explosive atmosphere due to local and operational conditions;

6 "group I": device intended for use in day of mines as well as their surfaces, which may be endangered by firedamp and/or combustible dust. This includes the device categories referred to in annex I, M1 and M2.

7 "device group II": equipment intended for use in the other areas which may be endangered by explosive atmospheres; This includes the categories listed in annex I, 1, 2, and 3;

8 "Device category": the layout of equipment within each device group referred to in annex I, of the necessary level of security that is necessary to ensure results;

9 "intended use": use of a product in a way that is, determined by the manufacturer as a result that he assigns the device of a specific device group and category or makes all details which are necessary for the safe operation of the protection system, device, or component;

10 "Making available on the market": any payment or free of charge of a product for distribution, consumption or use on the Union market in the course of a business;

11 "placing on the market': the first making available of a product on the Union market;

12 'Manufacturer': any natural or legal person who manufactures a product or develop or manufactured and marketed this product under their own name or their own trade mark or used it for their own purposes;

13.

"Authorised representative": each resident within the European Union, natural or legal person, in writing, appointed by a manufacturer to perceive certain tasks on his behalf;

14 "importer": each resident within the European Union, natural or legal person, who makes a product from a third country on the Union market;

15 'Dealer': any natural or legal person in the supply chain that provides a product on the market, with the exception of the manufacturer or the importer;

16 "Economic operators": the manufacturer, the agents, the importer and the Distributor;

17 'technical specification': a document in which the technical requirements are prescribed, a product must, conform

18. harmonised standard": a harmonized standard in accordance with the definition in article 2 paragraph 1, lit. c of the Regulation (EU) No. 1025 / 2012 to the European standardisation, amending Directives 89/686/EEC and 93/15/EEC as well as 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 repealing Decision 87/95/EEC and decision No 1673/2006/EC , OJ No. L 316 of the 14.11.2012 S. 12;

19 "Conformity assessment": the procedures for assessing whether the essential health and safety requirements this regulation in a product have; been fulfilled

20 "Conformity assessment body": a body that performs conformity assessment activities including calibration, testing, certifications and inspections;         

21 "Callback": any measure which one targets the end user of already provided electrical equipment on achieving the return;

22 "Redemption": any measure, that is, to prevent that a progress in the supply chain product on the market, provided

23 ' harmonisation legislation of the Union ': legislation of the European Union on the harmonisation of the conditions for the marketing of products;

24 "CE marking": marking by which the manufacturer declares that the product meets the requirements laid down in the harmonisation of legislation in the European Union about its affixing;

25 "Market surveillance authority": a pursuant to § 6 para 1 MING, § 13 ETG 1992 or pursuant to sections 170, 171 MinroG to carry out market surveillance authority;

Deployment on the market and putting into operation

4. (1) products must be only made available on the market and put into operation, if it with proper installation and maintenance, and intended use complies with this regulation.

(2) this Regulation shall not affect not the requirements that persons and in particular workers using the products in question were set to protect if this has any changes of these products in relation to the provisions of this regulation to the result.

(3) it is permitted that especially at trade fairs, exhibitions and demonstrations of this regulation products not be issued, provided that a visible sign clearly indicates that such products do not meet the requirements, and can be purchased only if the manufacturer has made compliance with this regulation. Demonstrations are appropriate security measures to take in order to ensure the protection of individuals.

Essential health and safety requirements

§ Must meet the essential health and safety requirements 5 products in annex II, which are applicable, taking into account its intended use on it.

Free movement of goods

§ 6. The making available on the market and the putting into service of products which comply with the provisions of this regulation, may neither be prohibited, limited, yet disabled.

2. section

Obligations of economic operators

Obligations of the manufacturers

§ 7 (1) the manufacturer must, if they put their products on the market, or they use for their own purposes, ensure that these have been designed in accordance with the essential health and safety requirements in annex II and manufactured.

(2) the manufacturer must create the technical documentation according to annexes III to IX and perform the relevant conformity assessment procedure according to § 14, or perform.



1 has been demonstrated with this procedure, that the product, which is not a component complies with the applicable requirements, the manufacturer issuing an EU Declaration of conformity and affix the CE marking.

2. was demonstrated with the appropriate conformity assessment procedure that a component complies with the applicable requirements, the manufacturer issue a written certificate of conformity according to § 14 para 3.

The manufacturers make sure that a copy of the EC declaration of conformity or the certificate of conformity is enclosed with each product. If however a large number of products at one and the same user is delivered, one copy may be in the relevant batch or delivery.

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

(4) the manufacturer must



1. by appropriate procedures ensure that compliance with this regulation in repetitive manufacturing is always ensured. Changes to the design of a product or its characteristics as well as changes in the harmonized standards or other technical specifications referred to in Declaration of conformity of a product must be considered appropriate;

2. If this given the risk posed by a product as reasonable is considered to protect of health and sampling of products provided on the market make the safety of consumers, they investigate and, if necessary, keep a register of complaints relating to non-compliant products and recalls of products and keep distributors informed of such monitoring.

(5) the manufacturer must ensure that products which they have placed on the market, a type, batch or serial number or a different flag wear their identification, or, where this is not possible because of the size or nature of the product that the required information on the packaging or in the product are specified documents.

(6) the manufacturer must ensure that products which they have placed on the market and are not components fitted Z 1.0.5 with the special characteristics of explosion protection and, where appropriate, other labels and information referred to in annex II.

(7) the manufacturer must their name, their company or registered trade mark and their mailing address, under which they are reached, specify either on the product itself or, if this is not possible, document accompanying the product on the packaging or in the. The address refers to a central point, at which the manufacturer can be achieved. The contact information is to specify in the German language.

(8) the manufacturer must ensure that the operating instructions and safety information in German language are enclosed with the product. These operating instructions and information, as well as all selections must be clear, understandable and clear.

(9) manufacturers who consider or have reason to believe that a product placed by them in traffic is not this regulation, must take immediate corrective measures to establish the conformity of this product or to withdraw it if necessary, or to call back. Also, the manufacturer if there are risks associated with the product, must immediately inform the market surveillance authorities of the Member States where they have deployed the product on the market, the Europäiaschen Union, in and making detailed information, in particular about the non-compliance and the corrective measures taken.

(10) the manufacturer have the market surveillance on their reasoned request all information and documents which are required to demonstrate of the conformity of the product with this regulation, to be in paper form or by electronic means in German language. They must cooperate with this authority at its request with all measures to prevent risks associated with electric Betriebsmittelen, which they have placed on the market.

Agents

8. (1) a manufacturer may nominate in writing a representative. The obligations referred to in article 7, paragraph 1, and the obligation to the creation of the technical documentation referred to in section 7, paragraph 2 are not part of the job of an agent.

(2) an authorised representative the tasks laid down by the manufacturer perceives, which are set on behalf of the manufacturer. The contract must allow the agent to carry out at least the following tasks:



1. keep the EC declaration of conformity or, where appropriate, the certificate of conformity and the technical documentation for the market surveillance authorities for a period of ten years after placing on the market of the product;

2.

on a reasoned request from a market surveillance authority or a national authority responsible for the control of external borders handed over all information and documentation necessary to demonstrate of the conformity of a product to this authority;

3. on request from the market surveillance authority cooperation in all measures to avert the risks associated with products that the remit of the agent belong.

Obligations of importers

Importers may bring only compliant products on the market § 9 (1).

(2) before you install a product on the market, importers shall ensure that the appropriate conformity assessment procedure was carried out according to § 14 of the manufacturer. Ensure that the manufacturer has created the technical documentation, that the product with the CE marking and the EC declaration of conformity or the certificate of conformity and the required documents are attached to him and that the manufacturer has satisfied the requirements of section 7, para. 5, 6 and 7.

Is an importer of considers or has reason to believe that a product does not match the essential health and safety requirements of annex II, he may bring this product into traffic before the conformity of the product is manufactured. If a risk associated with the product, the importer also inform the manufacturer and the market surveillance authority thereof.

(3) the importers have on the product even its name, their company or registered trade mark and their mailing address, which they can be contacted or if this is not possible, on its packaging or in the attached documentation to indicate the product. The contact information is to specify in the German language.

(4) the importer must ensure that the operating instructions and safety information in German language are enclosed with the product.

(5) while a product is under their responsibility, the importer must ensure that the conditions of its storage or its transportation do not affect the compliance of the product with the essential health and safety requirements of annex II.

(6) the importers have, if it is considered in light of the risks posed by a product as appropriate to make provided products to protect of the health and safety of end-users of sampling on the market, to investigate complaints and, if necessary, to keep a register of complaints, of non-conforming products and product recalls, and to keep distributors informed of such monitoring.

(7) importers who consider or have reason to believe that a product placed by them in traffic is not this regulation, must take immediate corrective measures to establish the conformity of this product or to withdraw it if necessary, or to call back. Also inform importers the market surveillance authorities of the Member States of the European Union, where they have deployed the product on the market, moreover, when are risks associated with the product, and do detailed information, in particular on the non-compliance and the corrective measures taken.

(8) the importer must after the placing on the market of the product for 10 years keep a copy of the EC declaration of conformity or, where appropriate, the certificate of conformity for the market surveillance authorities and ensure that they can submit these to the technical documentation on request.

(9) the importer must provide all information and documents which are required to demonstrate of the conformity of the product, the market surveillance authority whose following a reasoned request on paper or by electronic means in German language. They must cooperate with this authority at its request with all measures to prevent risks associated with products which they have placed on the market.

Obligations of distributors

The dealer must take into account the requirements of this regulation with due care § 10 (1), if they do not provide a product on the market.

(2) before you deploy a product on the market, the dealer must check whether the product with the CE marking, if required, provided the EU Declaration of conformity or the certificate of conformity and the required documentation and the operating instructions and safety information in German are attached to him, and whether the manufacturer and the importer have fulfilled the requirements laid down in article 7, par. 5, 6 and 7, and article 9, para. 3. A distributor considers or has reason to believe that a product does not match the essential health and safety requirements in annex II, he may provide this product not on the market before the conformity of the product is manufactured. A risk associated with the products the retailer must also inform the manufacturer or the importer, as well as the market surveillance.

(3) while a product is under their responsibility, the dealer must ensure that the conditions of its storage or its transportation do not affect the compliance of the product with the essential health and safety requirements of annex II.

(4) distributors who consider or have reason to believe that a product provided by them on the market is not this regulation, ensure that the necessary corrective measures are taken to establish the conformity of this product or to withdraw it if necessary, or to call back. Also, the dealer, when are risks associated with the product, immediately inform the market surveillance authorities of the Member States of the European Union, where they have deployed the product on the market, and this detailed information, in particular about the non-compliance and corrective measures must make.

(5) the Distributor must provide all information and documents that are necessary to demonstrate the conformity of a product, the market surveillance authority whose following a reasoned request in paper form or electronically. They must cooperate with this authority at its request with all measures to prevent risks associated with products that have made available on the market.

Circumstances under which the obligations of the manufacturer also apply to importers and distributors

§ 11. An importer or Distributor is the manufacturer for the purposes of this regulation and is subject to the obligations of a manufacturer in accordance with article 7, if it under his own name or his own trade mark on the market bringing a product or a product already on the market changed so that compliance with this regulation can be affected.

Identification of economic operators

Section 12 (1) the economic operators are obliged to call the economic actors of the market surveillance authorities on request,



1 of which they have; purchased a product

2 they have given to a product.

(2) the economic operators can present ten years after the purchase of the product, as well as ten years after the delivery of the product this information referred in paragraph 1.

3. section

Conformity of the product

Presumption of conformity of products

Section 13 (1) for products that comply with harmonised standards or parts thereof, the reference numbers of which have been published, is believed a conformity with the essential health and safety requirements set out in annex II which are covered by the relevant standards or parts thereof in the official journal of the European Union.

(2) where no harmonised standards exist, has the Minister for science, to take the necessary measures to research and industry, so that the existing national standards and technical specifications are brought those affected note, that are deemed important or useful for the proper implementation of the essential health and safety requirements set out in annex II.

Conformity assessment procedures

The conformity assessment procedures are section 14 (1) for devices and, if necessary, pursuant to section 1 para 1 as follows devices Z 2:



1. for device groups I and II, equipment category is 1 and 1 M to apply the EU type examination in accordance with annex III, and in conjunction with one of the following: a) conformity with the design on the basis of a quality assurance related to the production process referred to in annex IV or annex b) conformity with the design on the basis of an examination of the products referred to in annex V;

2. for device groups I and II, equipment-category M 2 and 2: a) for engines with internal combustion, and electrical equipment in these groups and categories, the EU type examination in accordance with annex III shall apply in connection with one of the following: aa) conformity with the design on the basis of an internal production control plus supervised product testing in accordance with annex VI, bb) conformity with type on the basis of quality assurance relative to the product in accordance with annex VII ,

b)

for the other devices in these groups and categories, the internal control of production referred to in annex VIII shall apply, and the technical documentation referred to in annex VIII shall be Z 2 a notified body, which immediately confirms the receipt of these documents and she kept;

3. for equipment group II, equipment category 3 is to apply the internal control of production referred to in annex VIII;

4. for device groups I and II: in addition to the procedures referred to in Nos. 1, 2 and 3 of this paragraph also conformity can be applied on the basis of an individual examination in accordance with annex IX.

(2) for protection systems conformity assessment is 4 procedure perform no. 1 or Z after in para 1.

(3) the procedures are used for components with the exception of the affixing of the CE marking and the exhibition of the EC declaration of conformity referred to in paragraph 1. The manufacturer must issue a written certificate of conformity, declaring the conformity of the components with the provisions of this regulation and of the characteristics of these components as well as the terms and conditions below are for their installation in the equipment and protective systems, which contribute, which are met for finished equipment and protective systems of applicable essential health and safety requirements set out in annex II.

(4) In relation to the in annex II Z 1.2.7 mentioned security issues can in addition to the conformity assessment procedures referred to in paragraphs 1 and 2 are also applied the procedure set out in annex VIII.

(5) by way of derogation from paragraphs 1, 2 and 4, the market surveillance authority at the duly justified request can the placing on the market and the commissioning of products, that no components are in domestic approval, on which that in paragraph 1, have not been applied to 2 and 4 procedure and the use of which is necessary in the interests of protecting.

(6) the documents and correspondence relating to conformity assessment procedures are according to the par. 1 to 4 to write in German.

EU Declaration of conformity

Section 15 (1) the EU Declaration of conformity States that compliance with the essential health listed in annex II and security requirements has been detected.

(2) the EU Declaration of conformity corresponds to the model in annex X in their construction, contains the elements specified in the relevant conformity assessment procedures of in annexes III to IX and be kept up to date. It is placed for products in the domestic market or made available on the market are to translate into German.

(3) a product is subject to several legal provisions of the European Union, where each a EU Declaration of conformity is required, only a single EU conformity declaration for all EU legislation is to exhibit. The relevant legislation of the European Union shall be indicated in this statement together with their site in the official journal.

(4) with the exhibition of the EU Declaration of conformity, the manufacturer assumes full responsibility, that the product complies with the requirements of this regulation.

General principles of the CE marking

§ 16. The General principles referred to in article 30 of Regulation (EC) apply to marking No. 765/2008 on the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93, OJ L 218 of the 13.8.2008 p. 30.

Rules and conditions for the affixing of the CE marking

Section 17 (1) is the CE marking visibly, legibly and permanently to the product or to its data plate to install. If the nature of the product does not allow this or does not justify, it is applied on the packaging and accompanying documents.

(2) the CE marking is affixed prior to the placing on the market of the product.

(3) behind the CE marking is the identification number of the notified body, if this place during the production control worked. The identification number of the notified body shall be affixed by the body itself or according to its instructions, by the manufacturer or his authorised representative.

(4) special explosion protection indicator, the indicator, which refer to the equipment group and category, and, where appropriate, other markings and information are Z 1.0.5 behind the CE mark and, where appropriate, the identification number of the notified body referred to in annex II.

(5) behind the CE marking and the marks, license plate information according to paragraph 4, as well as, where appropriate, the identification number of the notified body, another character can stand, indicating a special risk or use. Products that are designed for a particular explosive atmosphere must be marked accordingly.

(6) which has market surveillance to ensure that a proper implementation of the system of CE marking is guaranteed, and in the case of misuse of this labelling within the meaning of § 9 m ETG 1992 to initiate steps.

4 section

Conformity assessment

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

Section 18 (1) the Federal Minister for science, research and industry shall notify the European Commission and the other Member States of the European Union the bodies which have the power to perceive as a third-party conformity assessment tasks under this regulation.

(2) the Federal Minister for science, research and economy has the European Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, as well as to inform of any changes.

Requirements for notified bodies

19. (1) a conformity assessment body has the requirements for the purposes of notification to meet paragraph 2 to 11.

(2) a conformity assessment body must have been founded under Austrian law and have legal personality.

(3) in the case of a conformity assessment body's must be an independent third party, the with of the organisation or the product it assesses that, is no connection. A body that belongs to a trade association or a trade association and rated the products on their design, manufacturing, provision, Assembly, use or maintenance involved companies, which are represented by this association can be considered such a body, on the condition that its independence and the absence of any conflict of interest are demonstrated.

(4) a conformity assessment body, its top level of management and the personnel responsible for the conformity assessment tasks shall be not designer, manufacturer, supplier, Installer, purchaser, owner, user or maintenance operation of the products to be evaluated or representatives of one of these parties. This excludes using already an assessed products that are necessary for the activity of the conformity assessment body or the use of such products for personal use. A conformity assessment body, its top level of management and the personnel responsible for the conformity assessment tasks shall neither be involved directly in the design, manufacture or construction, marketing, installation, use or maintenance of those products, nor represent the parties involved in these activities. They may not deal with activities, which might impair their independence in assessing or their integrity relating to the conformity assessment activities for which they are notified. This applies particularly for consulting services.

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

(5) the conformity assessment body and its personnel have carried out the conformity assessment activities with the highest degree of professional and the necessary expertise in the relevant field; they should not be exposed any inducements, particularly financial, which could affect their judgement or the results of their conformity assessment activities, and specifically emanates from persons or groups of persons who have an interest in the outcome of these activities.

(6) a conformity assessment body must be able to resolve all conformity assessment tasks that was her regardless of whether these tasks are fulfilled by the body itself, on its behalf or under its responsibility in accordance with the annexes III to VII and annex IX to drop and for which they shall notify.

A conformity assessment body must at all times, each conformity assessment procedure and each species and category of products for which it has been notified, have about:



1. the necessary staff with technical knowledge and sufficient relevant experience to perform the conformity assessment tasks;

2.

Descriptions of procedures, according to which conformity assessment is carried out to ensure the transparency and the repeatability of these procedures; It must have adequate tools and appropriate procedures, distinction is made between the items that perceives as a notified body and other activities;

3. procedures for the implementation of activities, taking due account of the size of a company, the industry in which it operates, its structure, the degree of complexity of the product technology and the fact that the production process is a mass production or mass production.

A conformity assessment body must have the necessary resources to the appropriate technical and administrative tasks connected with conformity assessment, and have access to all necessary equipment or facilities.

(7) the employees who are responsible for carrying out the conformity assessment tasks, must have the following:



1. a sound technical and vocational training covering all the conformity assessment activities for which the conformity assessment body has been notified;

2. a satisfactory knowledge of the requirements associated with the reviews to be conducted, and the sufficient power to carry out such assessments;

3. appropriate knowledge and understanding of the essential health and safety requirements in annex II, of the applicable harmonised standards and of the relevant provisions of Community harmonisation of the Union and the relevant national legislation and 4 the ability to create certificates, protocols and reports as evidence of carried out reviews.

(8) the impartiality of the conformity assessment body, its top level of management and staff responsible for the conformity assessment activities must be guaranteed. The remuneration of top-level management and the personnel responsible for the conformity assessment tasks must not depend on the number of assessments carried or their results.

(9) the conformity assessment bodies have to complete a liability insurance.

(10) information, which receive the personnel of a conformity assessment body in carrying out its tasks in accordance with annexes III to VII and annex IX or any relevant national provisions, covered by the professional secrecy, which does not however apply to the market surveillance authorities and the Federal Minister for science, research and economy. Property rights must be protected.

(11) the conformity assessment bodies have notified bodies created under the directive in 2014/34/EC, to participate or to ensure that their personnel responsible for the conformity assessment tasks is informed of, the relevant standardisation activities and the activities of the coordination group. The conformity assessment bodies have to apply the administrative decisions drawn up by this group and documents as a general guideline.

Presumption of conformity for notified bodies

§ 20 a conformity assessment body demonstrates that it harmonised the criteria of the relevant standards or meets any part thereof, the reference numbers of which have been published in the official journal of the European Union, is believed that it meets the requirements according to § 19, insofar as the applicable harmonised standards cover those requirements.

Affiliates of notified bodies and subcontracting

§ 21 (1) awards the notified body specific tasks connected with conformity assessment on subcontractors or transfers it this a branch company, has to make sure, to teach that the subcontractor or the subsidiary meets the requirements of article 19, and the Federal Minister for science, research and economy.

(2) the notified bodies independently suffer the full responsibility for the work carried out by subcontractors or subsidiaries, wherever these are established.

(3) work may be only given to a subcontractor or transfer a branch company, if the customer agrees.

(4) the notified bodies have to provide the relevant documentation concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work performed by him in accordance with annexes III to VII and annex IX for the notifying authority.

Notification procedure

Section 22 (1) the Federal Minister for science, research and economy shall notify only conformity assessment bodies which meet the requirements pursuant to § 19.

(2) the notification must include full details of the conformity assessment activities, the conformity assessment modules and products, as well as the relevant certificate of competence.

Changes to the notification

Section 23 (1) if notes the Federal Minister for science, research and industry or is that a notified body no longer meets the requirements of article 19, or that it does not fulfil its duties, if necessary, restricting the notification, informed, puts them or revoke them, it takes account of the extent in which these requirements was not enough or has not complied with these obligations. He also immediately informed the European Commission and the other Member States of the European Union.

(2) restriction, suspension or withdrawal of the notification or if the notified body adjusts its activity, sent the files for further processing to another notified the notified body affected by the change of the notification and shall ensure that they are held for the notifying authority and the market surveillance authorities on request.

Challenge of the competence of notified bodies

Section 24 (1) the Federal Minister for science, research and economy given all information concerning the basis for the notification or the maintenance of the competence of the notified body the European Commission for the investigation of those cases where it doubts on the competence of a notified body or the continued fulfilment of the requirements and obligations by a notified body or her doubts be it brought to the attention, on request.

(2) in accordance with article 28 paragraph 4 of 2014/34/CE directive, the European Commission adopts an implementing Act if it finds that a notified body does not, or no longer meets the requirements for its notification. The Federal Minister for science, research and economy as a notifying authority applies corrective measures due to the European Commission's finding if necessary, including a withdrawal of the notification.

Obligations of notified bodies in relation to their work

Section 25 (1) the notified bodies have carried out conformity assessment in accordance with the conformity assessment procedures referred to in annexes III to VII and annex IX.

(2) conformity assessment conducted respecting of proportionality to be, and to avoid unnecessary burdens for economic operators. The notified bodies have their activities taking due account of the size of a company, to exert the industry in which it operates, its structure, as well as the level of complexity of the affected product technology and the Massenfertigungs - or serial nature of the production process. Here, they have however so strictly to proceed and to comply with such a level of protection, as this is required for the compliance of the product with the requirements of this regulation.

(3) a notified body finds that a manufacturer has not complied with the essential health and safety requirements, which are laid down in annex II or in the corresponding harmonized standards or other technical specifications, it has to ask the manufacturer to take appropriate corrective actions, and may issue any certificate.

(4) a notified body issued a certificate already notes in the context of the monitoring of conformity, that the product is no longer compliant, she has to ask the manufacturer to take appropriate corrective actions, and has the certificate or the approval if necessary to suspend or withdraw.

(5) any corrective action taken or they have not the necessary effect, has, where appropriate, to restrict all certificates and approvals, to suspend or withdraw the notified body.

Reporting obligations of notified bodies

The notified bodies have § 26 (1) the Federal Minister for science, to research and industry:



1. any refusal, restriction, suspension or withdrawal of a certificate or a licence, 2. have all the circumstances, the consequences for the scope or the conditions of notification 3. each request for information about conformity assessment activities, that they have obtained from the market surveillance authority, 4.

they are pursued on request, conformity assessment activities performed within the scope of their notification and what other activities, including cross-border activities and subcontracting, have executed.

(2) the notified bodies have the other bodies, which according to the 2014/34/CE directive are notified, out similar conformity assessment activities and covering the same products, to provide relevant information about the negative and, on request, positive conformity assessment results.

Coordination of notified bodies

§ 27. In accordance with article 33 of Directive 2014/34/EC, the notified bodies have directly or through notified representatives to take part in, which is established for an appropriate coordination and cooperation between bodies notified under this regulation by the European Commission and duly continued work by a coordination group.

5. section

Monitoring of the Union market, control of the products introduced on the Union market, safeguard-clause procedures

Union market monitoring and control of the products concerned on the Union market

Section 28 (1) products para 3 and articles 16 to 29 of Regulation (EC) apply article 15 No. 765/2008.

Procedure for the treatment of products involves a risk that

Section 29 (1) has reasonable grounds to believe that a risk to the health or safety comes from a product governed by this regulation of people or for domestic and farm animals or goods the market surveillance authority, it has to assess whether the product in question meets all the relevant requirements laid down in this regulation. The concerned economic operators have to cooperate with the market surveillance authorities for this purpose to the extent necessary. The market surveillance authorities in the course of the assessment reached according to para 1 to the result that a product meets the requirements of this regulation, she immediately the relevant economic operator to solicit, to take all appropriate corrective actions to establish the conformity of the product with these requirements, to withdraw it or to recall it within a period prescribed by the authority, appropriate to the nature of the risk. The market surveillance authority shall notify the relevant notified body. Article 21 of Regulation (EC) no 765/2008 shall apply to the measures referred to in this paragraph.

(2) the market surveillance authority of considers that the non-compliance not limited to the domestic, is she the Federal Minister for science to inform research and business in and this in turn has the European Commission and the other Member States of the European Union about the results of the assessment and the measures which the economic operator has been asked to teach. The Federal Minister for science, research and economy Announces notification of other Member States of the European Union of products with non-conformities of the market surveillance authority in appropriate manner.

(3) the economic operator shall ensure that all appropriate corrective action he takes, extend all affected products, which he has placed or made available on the market in the European Union.

(4) the relevant economic operator takes appropriate corrective measures, within the time limit referred to in paragraph 1, the market surveillance authority meets all appropriate provisional measures to prohibit the supply of the product on the domestic market or to restrict, to take the product from the market or to recall. The Federal Minister for science, research and economy shall inform the European Commission and the other Member States of the European Union without delay of these measures.

(5) all available information must emerge from the information referred to in paragraph 4, in particular, the data for the identification of non-compliant product, the origin of the product, the nature of the non-compliance alleged and the risk as well as the nature and duration of national measures taken and the arguments of the relevant economic operator. The Federal Minister for science, research and industry in particular indicates whether the non-compliance on one of the following causes is due to:



1. the product meets the requirements with regard to the health or safety of people or the protection of domestic and farm animals or goods not, or 2 that a presumption of conformity applies harmonised standards, in compliance with article 13, are flawed.

(6) another Member State initiated the process, the Federal Minister for science, research and industry informed the European Commission and the other Member States of the European Union without delay of all adopted measures and any further information about the non-compliance of the product and, if he disagrees with the notified national measure, over his objections.

(7) another Member State nor the European Commission within three months of receipt of the information referred to in paragraph 4 raises an objection to an interim measure of market surveillance authorities, this measure is considered justified.

(8) the market surveillance authority ensures that immediately appropriate restrictive measures, such as the withdrawal of the product from the market, in terms of the product concerned are met.

Compliant products that pose a risk

30. (1) after an assessment in accordance with article 29, paragraph 1 of the market surveillance authority determined that a product represents a risk to the health or safety of people or to House and farm animals or goods, although this regulation matches, has to invite them to the relevant economic operator to take all appropriate measures to ensure that the product concerned for its placing on the market no longer has this risk or that of within one type of risk reasonable that reasonable period of time, which may require them withdrawn or recalled.

(2) the economic operator has to ensure that the corrective action he takes, extend all affected products, which he has made available in the European Union on the market.

(3) the Federal Minister for science, research and economy shall inform the European Commission and the other Member States of the European Union forthwith. All available information must emerge from this information, particularly the data for the identification of the product, its origin, its supply chain, the type of risk and the nature and duration of national measures taken.

Formal non-compliance

Section 31 (1) without prejudice to article 29, paragraph 1 must urge the relevant economic operator the market surveillance authority to correct the non-compliance concerned if it detects one of the following cases:



1. the CE marking was in non-compliance with article 30 of Regulation (EC) No. 765/2008 or attached by § 17;

2. the CE marking has not been affixed;

3. the special explosion protection indicator, the indicator pointing to the equipment group and category and, where appropriate, other markings and information referred to in annex II were not attached Z 1.0.5;

4. the identification number of the notified body - if this place in the production control phase worked - was placed under non-compliance of article 17 or has not been affixed;

5. the EC declaration of conformity or, where appropriate, the certificate of conformity the product is not included;

6. the EC declaration of conformity or the certificate of conformity was not properly issued;

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

8. the information referred to in section 7 paragraph 7 or § 9 para 3 is missing, incorrect or incomplete;

9. any other request in accordance with section 7 or section 9 is not met.

(2) the non-compliance referred to in paragraph 1 persists, so the market surveillance authority must take all appropriate measures, to limit the supply of the product to the market or to prohibit or to ensure that it is recalled or withdrawn from the market.

6 article

Transitional and final provisions

Transitional provisions

32. (1) the market surveillance authority may not prevent that market products are provided or commissioned, which fall within the scope of the explosion protection regulations in 1996 and which comply with the provisions of this regulation and on or before April 20, 2016, in traffic were brought.

(2) certificates issued in accordance with Directive 94/9/EC remain valid in the context of this regulation.

(3) references to the Directive 94/9/EC is considered to be references to the 2014/34/CE directive.

Entry into force

§ 33. This regulation enter into force on the 20th April 2016. At the same time the explosion protection regulations in 1996, BGBl. No. 252/1996, override.

Linguistic equal treatment


§ 34. As far as this regulation are personal names only in the male form, they relate to women and men in the same way. When applied to certain persons, the respective gender-specific form is to use.

Mitterlehner



ANNEX I

Decision criteria for the classification of the device groups into categories

Essential requirements

1. General requirements



1 device group I a) device category M 1 comprises equipment that are structurally designed and so provided, if necessary, in addition with special protective measures are in accordance with the parameters specified by the manufacturer can be operated and ensure a very high level of security. The devices in this category are intended for use in underground mines as well as their surfaces, which are endangered by firedamp and/or combustible dust. Devices of this category must be continued even when rare device errors in existing hazardous atmospheres and have therefore explosion protection measures, so that - in the failure of a technical protection measure at least a second independent hammer protective measure ensures the required safety or - required security is provided in two independent failures occur.

The devices of this category must meet the other requirements of annex II Z 2.0.1.

(b) the device category M 2 comprises devices that are constructively so designed that they can be operated in accordance with the parameters specified by the manufacturer and guarantee a high level of security. Devices in this category are intended for use in underground mines as well as their surfaces, which may be endangered by firedamp and/or combustible dust. The devices must be designed to be switched off at the occurrence of an explosive atmosphere. The equip ment explosion protection measures in this category ensure the required degree of safety during normal operation, even under severe operating conditions and especially rough handling and changing environmental conditions. The devices of this category must meet the other requirements of annex II Z 2.0.2.

2. device group II a) 1 device category includes devices that are constructively so designed that they can be operated in accordance with the parameters specified by the manufacturer and ensuring a very high degree of security. Devices in this category are intended for use in areas in which an explosive atmosphere consisting of a mixture of air and gases, vapours or mist or dust/air mixtures, is constantly or langzeitig or often present. Devices in this category must ensure the necessary level of security even at rare device errors and have therefore explosion protection measures, so that - in the failure of a technical protection measure at least a second independent hammer protective measure ensures the required safety or - required security is provided in two independent failures occur.

The devices of this category must meet the other requirements of annex II Z 2.1.

(b) the equipment category 2 includes devices that are constructively so designed that they can be operated in accordance with the parameters specified by the manufacturer and guarantee a high level of security. Devices in this category are intended for use in areas where it is likely that an explosive atmosphere of gases, vapours, mist or dust/air mixtures occurs occasionally. The equip ment explosion protection measures of this category even with frequent device errors or error conditions, which are typically to be expected, ensure the necessary level of security. The devices of this category must meet the other requirements of annex II Z 2.2.

(c) the equipment category 3 includes devices that are constructively so designed that they can be operated in accordance with the parameters specified by the manufacturer and guarantee a normal security. Devices in this category are intended to be used in areas where it is likely that an explosive atmosphere by gases, vapors, mists or dispersed dust occurs, but if it still occurs, then in all likelihood only infrequently and for a short period. Instruments of this category ensure the required degree of safety during normal operation. The devices of this category must meet the other 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

Before you begin



A. must without delay the technical knowledge which is changing fast, and to the extent as possible are applied.

(B).
For related devices according to § 2 para 1 subpara 2 lit. the essential health and safety requirements apply b only in so far as they are necessary for a safe and reliable function and use these facilities with regard to the risk of explosion.

1. common requirements for equipment and protective systems of 1.0 General requirements be 1.0.1. principles of integrated explosion safety that conception of equipment and protective systems intended for use in potentially explosive atmospheres must be according to the principles of integrated explosion safety. To do this, the manufacturer has to measures must be taken - primarily, if it is possible to avoid explosive atmospheres which may be produced or released by the equipment and protective systems themselves

-the ignition of potentially explosive atmospheres under consideration of electrical and non-electrical types of ignition source in some cases to prevent;

-If it's still an explosion should occur, the danger to people and, where appropriate, of domestic and farm animals or goods by direct or indirect exposure to cause, to stop it immediately and/or to limit the range of explosion flames and explosion pressures to a sufficient safe level.

1.0.2. equipment and protective systems are considering possible error conditions to design and manufacture to eliminate dangerous situations as far as possible.

In the contemplation is also reasonably foreseeable misuse.

1.0.3. special inspection and maintenance conditions equipment and protective systems which are subject to special inspection and maintenance conditions must be designed in accordance with these terms and conditions and built.

1.0.4 ambient conditions equipment and protective systems must be designed with regard to existing or foreseeable environmental conditions and built.

1.0.5. marking on each device and protection system must clearly and indelibly the following minimum information be attached: - name, registered trade name or registered trade mark and address of the manufacturer, - CE marking (see annex II of to Regulation (EC) no 765/2008), - label series and of the type, - where appropriate, the batch or serial number, - year, - the special explosion protection indicator, followed by the tag that refers to the device group and category , - for the device group II the letter "G" (for areas where explosive gas -, vapour -, mist - and air mixtures are present) and/or - the letter "D" (for areas in which explosive atmospheres dust form can).

1.0.6. operating instructions a) to each device or protection system operating instructions must exist, which contain the following minimum information:-same details as in the marking for equipment or protective systems (see Z 1.0.5) with the exception of batch or serial number and, where appropriate, maintenance-related information (such as addresses by service workshops, etc.);

-Indicated to the or up to the safe - commissioning - use, Assembly and disassembly, - maintenance (maintenance and troubleshooting), -;

-If necessary, the marking of hazardous areas before relief devices;

-If necessary, information on training;

-Information clearly enabling the decision whether the use of a device (according to its designated category) or a protective system in the intended area under the conditions to be expected is safe to do so;

-electrical characteristics and pressures, maximum surface temperatures and other limit values;

— where necessary, special conditions of use, including the evidence of improper usage, which experience has shown can occur;

-If necessary, the basic features of the tools of that can be affixed to the equipment or protective system.

(b) the operating manual includes the plans necessary for the operation, maintenance, inspection, checking the functioning of and, where appropriate, repair of the equipment or protective system and schemes, as well as all relevant information, in particular with regard to the security.

(c) with regard to the security aspects, the documents in which the equipment or protective system is presented, may not stand contrary to the operating instructions.

1.1.

Selection of materials 1.1.1.
The materials used for the construction of equipment and protective systems may cause not triggering an explosion, taking into account foreseeable operational stresses.

1.1.2. within the operational limits of foreseeable by the manufacturer no reactions of the materials with the components forming the explosive atmosphere must be conducted, which may lead to a damage of the explosion safety.

1.1.3. materials must be that predictable changes in their characteristics and their compatibility in combination with other materials to any lead abatement safety, in particular with regard to the corrosion behavior, wear, electrical conductivity, mechanical strength, ageing resistance and the effects of changes in temperature 1.2 1.2.1. equipment and protective systems are design and construction taking into account the technical knowledge in the field of explosion protection as to construct and manufacture selected so, , that they can be operated safely during their expected lifetime.

1.2.2. for installation in equipment and protective systems or as spare parts, provided components are to construct and to establish that they are their uses according to reliable with regard to explosion protection if they are installed according to the manufacturer's instructions.

1.2.3. closed construction and prevention of leaks for devices, flammable gases or dust can escape from which is possible to envisage the closed construction.

As far as possible devices that have holes or leaks, may not allow leakage of gases or dusts so that no explosive atmosphere can form outside of the devices.

Points where materials are entered or removed, must can be as far as possible so planned and equipped, that escape when filling or draining any flammable substances.

1.2.4. dust deposits are designed that dust can not ignite on their surfaces of equipment and protective systems which are intended to be used in dusty areas.

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

The surface temperatures of equipment parts must be less than clearly deposited dust ignition temperatures.

The thickness of the deposited dust is to pull a heat accumulation into consideration and if necessary to take into account temperature limit.

1.2.5. additional protective equipment and protective systems, that are exposed to possibly outer special kind, if necessary, must be equipped with additional protective measures.

The equipment must withstand the corresponding loads without affecting the explosion protection.

Equipment and protective systems are arranged 1.2.6. safe opening in a housing or under lock and key, which are part of the explosion protection itself, so it should be possible only by means of appropriate protection measures or a special tool to open it.

1.2.7. protection against other hazards equipment and protective systems must be so designed and manufactured, that a) be avoided injuries or other damage, caused by direct or indirect contact

(b) is ensure that accessible parts not dangerous surface temperatures or hazardous radiations occur at;

(c) experience has shown that any non-electrical hazards are excluded;

(d) ensure is that foreseeable conditions of overload cause any dangerous situations.

The risks referred to in this Z, of equipment and protective systems, wholly or in part by other legislation of the European Union gathered, so the regulation does not apply to these devices and protection systems, and these risks or applies to this from the date of application of this specific legislation of the European Union no more.

1.2.8. overloading of equipment dangerous overloading of equipment already is development with integrated equipment of measurement, to meet tax - and control engineering, especially with excess power triggers, temperature limiters, differential pressure switches, flow sensors, timers, speed monitors and/or similar types of monitoring devices.

1.2.9. flameproof encapsulation equipment parts which can ignite an explosive atmosphere, enclosed in a case, so is to ensure that the housing can withstand in the explosion of an explosive mixture in the inner pressure and a transmission of the explosion to the explosive atmosphere surrounding the enclosure is prevented.

1.3. potential ignition sources by different types of ignition source Sparks, flames, electric arcs, high surface temperatures, sound energy, radiation in the optical field, electromagnetic waves as well as other types of ignition source with ignition capable potential may not emerge 1.3.1. hazards.

1.3.2. hazards must be avoided by static electricity electrostatic charges that can lead to dangerous discharges through appropriate measures.

1.3.3. hazards must be prevented by electrical leakage and leakage electric machine and leakage currents in conductive equipment parts which lead to the formation of flammable Sparks, overheating of surfaces or dangerous corrosion.

1.3.4. hazards resulting from excessive temperature rise are inadmissible overheating can be caused by friction and impact processes such as between materials, in rotating parts or by the intrusion of foreign bodies, as far as possible to avoid constructive ways.

1.3.5. risks associated with pressure compensation operations equipment and protective systems designed or fitted with integrated facilities of measuring -, steering - and control technology must that of them outbound pressure compensation operations generate no shock waves or compressions, which can cause an explosion.

1.4. hazards external disturbance influences 1.4.1.
The equipment and protective systems must be so designed and built, that they meet their intended function safely even under changing environmental conditions, under the influence of external voltages, when moisture loads, vibrations, dirt and other outer disturbance influences within the limits of the operating conditions specified by the manufacturer.

1.4.2. equipment parts must be appropriate to the intended mechanical and thermal stresses and withstand the effects of existing or predictable aggressive substances.

1.5. requirements for safety devices 1.5.1 safety devices must operate independently of operationally required measurement and/or control devices.

As far as possible, the failure of a safety device must be recognized quickly enough through appropriate technical measures, so that dangerous conditions with high probability can not enter.

Basically, the principle of safe misconduct (fail safe) is to apply.

Safety switching operations must generally act without software control directly on the corresponding actuator.

1.5.2. as far as possible, the equipment or protective system must be transferred at failure of safety devices in a safe state.

Restart lockouts must, as far as possible, have 1.5.3. emergency stop switch of safety devices. A new start command should only be possible for the normal operation if before the restart lockouts have deliberately been lifted.

1.5.4 operating and display devices are operating and display devices used, this should be with regard to the risk of explosion according to ergonomic principles to design, to achieve maximum operating safety.

1.5.5. requirements for devices with a measuring function for explosion protection are devices with a measuring function, affecting equipment in potentially explosive atmospheres, accordingly to build and develop in particular the foreseeable operating requirements and special conditions of use.

1.5.6. the accuracy and functionality of devices with a measuring function can be checked if necessary.

1.5.7. a safety factor must be based on the design of devices with a measuring function, which ensures that the alarm threshold, especially with regard to the operating conditions of the institution and any variations of the measuring system, far enough outside the explosion and/or ignition limits of the atmospheres to collect lies.

1.5.8. risks must be considered the risks especially by software in the design of equipment, protective systems and safety devices, which are controlled by software, due to error in the program.

1.6. integration of security-relevant system requirements 1.6.1.
In the automatic operation devices and protective systems which deviate from the intended operating can be switched off by hand, as long as it does not affect the security.

1.6.2.

Stored energy must be when pressing the emergency as quickly and safely as possible which mined isolated, so that they lose their dangerous effects.

This does not apply to electrochemically-stored energy.

Energy loss in equipment and protective systems, where a power failure can lead to additional risks, a safe operating condition must be independently from the rest of the operating system maintain 1.6.3. hazards.

1.6.4. hazards resulting from connections equipment and protective systems must be fitted with suitable glands for cables and wires.

Equipment and protective systems which are intended to be used in conjunction with other equipment or protective systems must be safe in terms of the interfaces.

1.6.5. arrangement of alarms as part of a device equipment or protective systems are fitted with detector or alarms to display the formation of potentially explosive atmospheres, so information is required, providing a suitable installation of the devices.

2. further requirements for equipment 2.0 requirements for devices in the device group I 2.0.1. requirements for device category M 1 of equipment-group I 2.0.1.1.
The devices must be so designed and manufactured that ignition sources self at rare device errors are not effective.

You must be equipped with explosion protection measures, so that - in the failure of a technical protection measure at least a second independent hammer protective measure ensures the required safety or - when two independent failures occur, the necessary level of security is ensured.

If necessary, the equipment must be equipped in addition with special protective measures.

You must continue to operate at existing hazardous atmospheres.

2.0.1.2. the devices must be so constructed that, where necessary, no dust can penetrate them.

The surface temperatures of equipment parts must be 2.0.1.3. in terms of inflammation by whirled-up dust well below the ignition temperature of foreseeable dust/air mixtures.

2.0.1.4. which are devices to construct that the opening of equipment parts, the ignition sources can be possible only in the free energy or intrinsically safe state, so is. A device is not disabled, so the manufacturer must affix a warning on the parts of the device, open.

If necessary, the devices with appropriate additional locking mechanisms must be equipped.

2.0.2. requirements for device category M 2 of equipment-group I 2.0.2.1.
The devices must be equipped with technical protection measures, which ensure that ignition sources during normal operation, even under difficult conditions and especially rough handling and changing environmental influences, are not effective.

The occurrence of an explosive atmosphere the devices can switching off.

2.0.2.2. which are devices to construct that the opening of equipment parts which may be sources of ignition is possible only disconnected from the energy or via appropriate interlocking systems. A device is not disabled, so the manufacturer must affix a warning on the parts of the device, open.

2.0.2.3. in terms of dust explosion protection are to comply with the requirements of device category M 1.

2.1. requirements for device category 1 of equipment-group II of 2.1.1. explosive atmospheres caused by gases, vapours or mist 2.1.1.1.
The devices are to construct and manufacture to avoid sources of ignition even at rare device errors.

You must be equipped with explosion protection measures, so that - in the failure of a technical protection measure at least a second independent hammer protective measure ensures the required safety or - when two independent failures occur, the necessary level of security is ensured.

2.1.1.2. for devices, whose Oberflächen to warm, make sure that the specified highest surface temperatures also in the worst case will not be exceeded.

These are also temperature increases due to heat and chemical reactions into account.

2.1.1.3. which are devices to construct that the opening of equipment parts, the ignition sources can be possible only in the free energy or intrinsically safe state, so is. A device is not disabled, so the manufacturer must affix a warning on the parts of the device, open.

If necessary, the devices with appropriate additional locking mechanisms must be equipped.

2.1.2. explosive dust/air mixtures 2.1.2.1 atmosphere.
The devices are to construct and manufacture prevent inflammation of dust/air mixtures self at rare device errors.

You must be equipped with explosion protection measures, so that - in the failure of a technical protection measure at least a second independent hammer protective measure ensures the required safety or - when two independent failures occur, the necessary level of security is ensured.

2.1.2.2. where necessary the devices built so be that dust can penetrate only at the designated places in them or leave them.

Provided introductory and connecting components must also meet this requirement.

The surface temperatures of equipment parts must be in terms of not inflammation whirled up dust well below the ignition temperature of foreseeable dust/air mixtures 2.1.2.3.

The relevant requirement 2.1.1.3 applies 2.1.2.4. with regard to the safe opening of equipment.

2.2. requirements for device category 2 of equipment-group II of 2.2.1. explosive atmospheres caused by gases, vapours or mists 2.2.1.1.
The devices are to design and manufacture that ignition sources are avoided even when frequently occurring device disturbances or incorrect operating conditions, which usually must be expected.

2.2.1.2 the surface temperatures are to construct the parts of the appliance and to establish that these are not exceeded even with unusual operating situations provided for by the manufacturer.

2.2.1.3 which are devices to construct that the opening of equipment parts which may be sources of ignition is possible only disconnected from the energy or via appropriate interlocking systems. A device is not disabled, so the manufacturer must affix a warning on the parts of the device, open.

2.2.2. explosive dust/air mixtures 2.2.2.1 atmosphere.
The devices are to construct and to establish that there can be no even when frequently occurring device disturbances or error conditions, which usually must be expected, ignition of dust/air mixtures.

The requirement 2.1.2.3 applies 2.2.2.2 with regard to surface temperatures.

The requirement 2.1.2.2 applies 2.2.2.3 concerning dust protection.

The relevant requirement 2.2.1.3 applies 2.2.2.4 with regard to the safe opening of equipment.

2.3. requirements for device category 3 of Group II of 2.3.1. explosive atmospheres caused by gases, vapours or mists 2.3.1.1.
The devices are to construct and to produce predictable expected sources of ignition, which can occur during normal operation to avoid.

2.3.1.2 occurring surface temperatures shall not exceed the specified highest surface temperatures in order to ensure correct operation. Exceeding is only allowed in exceptional cases, if the manufacturer additional special protection measures have been taken.

2.3.2. explosive dust/air mixtures 2.3.2.1 atmosphere.
The devices are to construct and manufacture that dust/air mixtures will not ignite under normal operating conditions to be expected from sources of ignition.

The requirement 2.1.2.3 applies 2.3.2.2. with regard to surface temperatures.

2.3.2.3 the devices including the provided introductory and connecting parts must be designed taking into account the size of dust particles that explosive dust/air mixtures nor hazardous dust deposits can form on the inside.

3. additional requirements for protective systems of 3.0 General requirements 3.0.1 protection systems must be dimensioned so that effects are limited by explosions on a sufficiently safe measure.

3.0.2. the protection systems must be designed and arranged so can prevent explosion transfers through dangerous chain reactions and flame jet ignition as well as transitions from running on explosions in detonations.

3.0.3. failure of energy supply, the protection systems over a reasonable period of time must maintain their functionality to avoid dangerous situations.

3.0.4. protective systems must not fail add happen under the influence of external disturbance influences.

3.1. planning and design 3.1.1. are material properties of the expected explosion pressure under extreme operating conditions as maximum explosion pressure, as well as the expected heating effect of the flame while designing the material properties to consider.

3.1.2.

Protection systems, which serve to the back or under control keep from explosions, must be able to withstand pressure surges without losing system integrity.

3.1.3. the faucets connected to protective systems must withstand the expected maximum explosion pressure without losing their functionality.

3.1.4. the pressure conditions expected in peripheral equipment and connected pipe lines are taken into account with regard to their repercussion in the planning and design phase of the protection systems for the incipient.

3.1.5. relief devices is to be expected that stressed the protection systems used on their strength of the material, then are appropriate relief facilities in a manner safe for persons present in the immediate vicinity to project;

3.1.6. explosion suppression systems explosion suppression systems must be so planned and designed that they capture the current explosion at an earliest possible date in emergencies and optimally counteract you, taking into account the maximum time pressure increase and the maximum explosion pressure.

3.1.7 technical of explosion decoupling systems decoupling systems intended in the case to make the separation of certain devices by appropriate devices in the shortest time, must be so planned and designed that their ignition dielectric reliability and mechanical strength under operating conditions are guaranteed.

3.1.8 the protection systems must be integrated into a circuit-technical concept with a suitable alarm threshold so that, if necessary, a shut-down of the product feed and discharge, as well as those parts of the appliance, which no longer guarantee safe operation.

ANNEX III

Module B: EC type examination



1. when the EU type examination is the part of a conformity assessment procedure whereby a notified body examines the technical design of a product and verifies and certifies that it meets the requirements of this Regulation applicable to the product.

2. the EU type examination is performed as a representative for the production envisaged pattern of the full product (building design).

3. the request for EU type examination is from the manufacturer with a single notified body of his choice to submit.

              The application contains the following:



a) name and address of the manufacturer and, if the application is lodged by the authorised representative, its name and address;

(b) an affidavit is filed the same request with any other notified body;

(c) the technical documentation. On the basis of these documents, it must be possible to evaluate the compliance of the product with the applicable requirements of this regulation; they must contain a proper risk analysis and evaluation. The requirements list and the design to capture the production and the operation of the product, as far as they are for the assessment of relevant are in the technical documentation. The technical documents contain at least the following elements: i) a general description of the product, ii) designs and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc., iii) descriptions and explanations that are necessary to the understanding of the said drawings and diagrams and the operation of the product iv) a list of the harmonised standards, the reference numbers of which have been published in the official journal of the European Union fully or in part have been applied , and, if these standards were not applied, a description with which solutions has been complied with the essential health and safety requirements of this regulation, including a statement, which other relevant technical specifications have been applied. The parts which have been applied, are specified in the technical documentation in the event of partly applied harmonised standards, v) the results of design calculations, examinations carried out, etc. as well as vi) d test reports) of the representative samples of production. The notified body may request additional patterns, if this is necessary for the implementation of the review programme.

4. the notified body shall have the following duties: 4.1. examination of the technical documentation, testing, whether that and the pattern in accordance with the technical documentation was established / n, and finding, which parts have been designed according to the regulations of the relevant harmonised standards and which parts to other relevant technical specifications designed;

4.2. implementation and request the appropriate examinations and tests, to determine whether the solutions in the relevant harmonised standards, been applied properly unless the manufacturer has opted for their application;

4.3. implementation and request the appropriate examinations and tests, to determine whether the solutions that were elected by manufacturers, applies the solutions from other relevant technical specifications, the relevant essential health and safety requirements of this regulation meet, if he has not applied to the solutions in the relevant harmonised standards;

4.4. agreement with the manufacturer, where the examinations and tests to be performed.

5. the notified body creates an audit report on the measures carried out in accordance with no. 4 and the results obtained. Without prejudice to their obligations under the notifying Authority published the notified body the content of this report, or parts of them only with the consent of the manufacturer.

6 the sample corresponds to the requirements applicable to the product in question this regulation provides the notified body the manufacturer an EU type examination certificate from. The certificate must contain the name and address of the manufacturer, the results of the audit, any conditions for its validity and the particulars necessary for identification of the approved of type. One or more attachments can be added to the EU type examination certificate.

The EU type examination certificate and its annexes contain all relevant information, by which the conformity of the manufactured products assessed with the tested models and, if necessary, a control is after her commissioning.

Corresponds to the sample refused not the applicable requirements of this regulation the notified body the exhibition an EU type examination certificate and shall inform the applicant about where she extensively justified its refusal.

7. the notified body shall inform continuously about all changes in the generally acknowledged State of the art; These indicate that the approved type no longer complies with the applicable requirements of this regulation, it decides whether such changes require further investigations. This is the case, so the notified body shall inform the manufacturer accordingly.

The manufacturer shall inform the notified body, the technical documentation for the EU type examination certificate of all changes to the approved design that may affect the conformity with the essential health and safety requirements of this regulation or the conditions for the validity of this certificate. Such modifications require additional approval in the form of an addition to the original EU-type test certificate.

8. each notified body shall inform their notifying authority of the EU type examination certificates and/or any additions, which has issued them, or withdrawn, and submitted a list of all such certificates and/or additions to, who has denied, suspended or otherwise restricted their notifying authority at regular intervals or at the request.

Each notified body shall inform the other notified bodies of the EU type examination certificates and/or any additions, which has denied, withdrawn, suspended or otherwise restricted, and tells if it is prompted to do so, from your issued certificates and/or additions to all them.

If you require 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 additions. The European Commission and the Member States will receive on request a copy of the technical documentation and the results of the checks made by the notified body. The notified body shall so long kept a copy of the EU test certificate together with the annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the period of validity of this certificate.

9. the manufacturer holds a copy of the EU test certificate together with the annexes and additions together with the technical documentation for 10 years after the placing on the market of the product for the market surveillance authorities.

10.

The authorised representative of the manufacturer can submit the application referred to in no. 3 and meet the obligations referred to in the Nos. 7 and 9, if they are set in the order.



ANNEX IV

Module D: involved conformity with the design on the basis of a quality assurance on the production process



1. in conformity with type on the basis of a quality assurance related to the production process is the part of a conformity assessment procedure, in which the manufacturer in the Z meets the 2 and 5 laid down obligations and ensures and declares on its own responsibility that the products concerned conform to the type described in the EU type examination certificate and comply with the applicable requirements of this regulation.

2. making the manufacturer operates a certified quality assurance system for production, final product inspection and testing of the products concerned in accordance with no. 3 and is subject to the surveillance referred to in no. 4.

3. quality system 3.1.
The manufacturer must apply to a notified body of his choice of the assessment of his quality system for the products concerned.

              The application contains the following:



a) name and address of the manufacturer and, if the application is lodged by the authorised representative, its name and address;

(b) an affidavit is filed the same request with any other notified body;

(c) all relevant information for the product category envisaged;

(d) the documentation concerning the quality assurance system;

(e) the technical documentation of the approved type and a copy the EU type examination certificate.

3.2. the quality assurance system ensures conformity of the products with the type described in the EU type examination certificate and with the applicable requirements of this regulation.

All elements considered by the manufacturer, requirements, and provisions are systematically and properly in the form of written policies, to assemble procedures and instructions. This quality assurance system documentation must permit a uniform interpretation of the quality programmes, plans, manual and reports.

Contain in particular an adequate description the following points: a) quality objectives and organizational structure, responsibilities and powers of the Executive Board in regard to product quality;

b) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions;

c) before, during and investigations carried out after manufacturing and testing frequency;

(d) the relevant quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc; and e) funds will be used to monitor the achievement of the required product quality and the effective operation of the quality assurance system.

3.3. the notified body must assess the quality assurance system, to determine whether it meets the requirements referred to in 3.2 Z.

In each part of the quality assurance system, which complies with the corresponding specifications of the relevant harmonised standard, it comes from a conformity with these requirements.

In addition to experience in quality management systems, at least one member of the audit has experience with the evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this regulation. The audit includes also an inspection visit at the premises of the manufacturer. The audit team reviewed the in Z 3.1 lit. referred e technical documentation, to ensure that the manufacturer able is to identify the relevant requirements of this regulation and making the necessary verifications, to ensure conformity of the product with these requirements.

The decision is notified to the manufacturer. The notification must contain the conclusions of the audit and the reasoned of assessment decision.

3.4. the manufacturer is committed to meet the obligations associated with the approved quality assurance system and ensuring that it is held always correctly and efficiently.

3.5. the manufacturer shall inform the notified body that has approved the quality system of any planned changes of the quality assurance system.

The notified body shall assess all proposed changes and decide whether the modified quality assurance system complies with still referred to Z 3.2 or whether a re-assessment is required.

It announces its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned of assessment decision.

4. surveillance under the responsibility of the notified body 4.1.
The monitoring is to ensure that the manufacturer duly fulfils the obligations arising from the approved quality system.

4.2. the manufacturer grants access to the manufacturing, inspection, testing and storage of the notified body for assessment and provides all necessary documents you to, in particular: a) the documentation concerning the quality assurance system;

(b) the relevant quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

4.3. the notified body shall regularly conducts audits to ensure that the manufacturer is maintaining the quality assurance system and applies and passes him a corresponding report.

4.4. Additionally, the notified body the manufacturer may carry out unannounced visits. During these visits, the notified body may, if necessary, carry out product tests or undergo, in order to ensure the proper functioning of the quality assurance system. The notified body shall supply the manufacturer with a report on the visit and in the case of an examination report.

5. CE-marking, EC declaration of conformity and certificate of conformity 5.1.
The manufacturer must affix their identification number to each individual product that is not a component and that matches the models described in the EU type examination certificate and meets the applicable requirements, marking, and - under the responsibility of the notified body referred to in 3.1 Z -.

5.2. the manufacturer issues a written EC declaration of conformity for each product model, which is not a component, and it keeps for ten years after the placing on the market of the product, which is not a component, ready for the market surveillance authorities. Must be drawn from the EU Declaration of conformity was issued which product model.

Any product that is not a component, is accompanied by a copy of the EC declaration of conformity.

5.3. the manufacturer issues a written certificate of conformity for each model of component and holds it for a decade after the placing on the market of the component for the market surveillance authorities. The Declaration of conformity must be drawn for any component model was issued. Each component is attached to a copy of the certificate of conformity.

6 the manufacturer for ten years after the placing on the market of the product for the market surveillance authorities the following documents provides: a) the documentation referred to in 3.1; Z

(b) the information on the amendment in accordance with Z 3.5 in its approved form;

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

7. each notified body shall inform their notifying authority the approval of quality assurance systems that has issued it or withdrawn, and submitted a list of all approvals of quality assurance systems, which has denied, suspended or otherwise restricted their notifying authority at regular intervals or at the request.

Each notified body shall inform the other notified bodies about the certifications of quality assurance systems, which has denied, suspended, withdrawn or otherwise restricted, and request the approval of quality assurance systems, which has granted them.

8. authorised representative can 3.1, 3.5, 5 and 6 referred to obligations of the manufacturer under the Z of his authorised representative, on his behalf and under its responsibility are met, if they are set in the order.

ANNEX V

Module F: conformity with the design on the basis of a product audit



1 the conformity type on the basis of an examination of the products it is the part of a conformity assessment procedure, where the manufacturer in the Z meets the 2 and 5 laid down obligations and guarantees and on their own responsibility declares that the 3 submissive affected products described in the EU type examination certificate type comply with the provisions of Z and comply with the applicable requirements of this regulation.

2.


The manufacturer shall take all measures necessary to ensure the manufacturing process and its monitoring the conformity of the manufactured products with the type described in the EU type examination certificate and with the applicable requirements of this regulation.

3. check performs a notified body chosen by the manufacturer with the appropriate examinations and tests to check the conformity of the products with the approved type described in the EU Baumusterprüfbescheinigung and the corresponding requirements of this regulation.

The examinations and tests to check of the conformity of the products with the appropriate requirements are carried out by means of examination and testing of each product in accordance with no. 4.

4. verification of conformity by examination and testing of every single product of 4.1.
All products are tested individually, and there will be the corresponding checks according to the relevant harmonised standard (s) and/or equivalent tests that are listed in other relevant technical specifications. carried out to verify their conformity with the approved type described EU type-examination certificate and the applicable requirements of this regulation.

In the absence of such a harmonised standard, the notified body shall decide what checks are performed.

4.2. the notified body shall issue a certificate of conformity on the basis of these examinations and tests and affix its identification number to each approved product or can bring them under their responsibility.

The manufacturer holds the certificates of conformity for ten years after the placing on the market of the product for which the market surveillance authorities for inspection.

5. CE-marking, EC declaration of conformity and certificate of conformity 5.1.
The manufacturer shall affix to each individual product that is not a component and that corresponds to type approved and described in the EU type examination certificate and satisfies the applicable requirements of this regulation, the CE marking and - under the responsibility of the notified body referred to in no. 3 - whose identification number.

5.2. the manufacturer issues a written EC declaration of conformity for each product model, which is not a component, and it keeps for ten years after the placing on the market of the product, which is not a component, ready for the market surveillance authorities. Must be drawn from the EU Declaration of conformity was issued which product model.

Any product that is not a component, is accompanied by a copy of the EC declaration of conformity.

Agrees with the notified body referred to in no. 3 the manufacturer under the responsibility of the notified body can now attach the identification number of the notified body on the products that are not components.

5.3. the manufacturer issues a written certificate of conformity for each model of component and holds it for a decade after the placing on the market of the component for the market surveillance authorities. The Declaration of conformity must be drawn for any component model was issued. Each component is attached to a copy of the certificate of conformity.

6. agrees to the notified body, the manufacturer, under the responsibility of the notified body can now attach the identification number of the notified body during the manufacturing process on the products.

7 authorised representative, the obligations of the manufacturer can be fulfilled by his authorised representative, on his behalf and under his responsibility, unless they are set in the order. An authorised representative must meet not the manufacturer's obligations set out in no. 2.

ANNEX VI

Module C1: Conformity with the design on the basis of an internal production control plus supervised product testing



1 the conformity type on the basis of an internal production control plus supervised product testing it is the part of a conformity assessment procedure, in which the manufacturer fulfils the obligations laid down in the Nos. 2, 3 and 4 and ensures and declares on its own responsibility that the products concerned conform to the type described in the EU type examination certificate and comply with the applicable requirements of part 2 of this regulation.

2. making the manufacturer take all measures necessary to ensure the manufacturing process and its monitoring the conformity of the manufactured products with the type described in the EU type examination certificate and with the applicable requirements of this regulation.

3. product tests be made one or more tests on one or more specific aspects of the product on each individual product manufactured by the manufacturer or on his behalf, to check the conformity with the type described in the EU type examination certificate and with the relevant requirements of this regulation. These tests are carried out under the responsibility of a notified body chosen by the manufacturer.

The manufacturer shall affix the identification number of the body under the responsibility of the notified body during the manufacturing process.

4. CE marking, EC declaration of conformity and certificate of conformity 4.1.
The manufacturer must affix the CE marking to each individual product, which is not a component, and which matches the design described in the EU type examination certificate and satisfies the applicable requirements of this regulation.

4.2. the manufacturer issues a written EC declaration of conformity for a product model which is not a component, and it keeps for ten years after the placing on the market of the product, which is not a component, ready for the market surveillance authorities. Must be drawn from the EU Declaration of conformity was issued which product model.

Any product that is not a component, is accompanied by a copy of the EC declaration of conformity.

4.3. the manufacturer issues a written certificate of conformity for each model of component and holds it for a decade after the placing on the market of the component for the market surveillance authorities. The Declaration of conformity must be drawn for any component model was issued. Each component is attached to a copy of the certificate of conformity.

5. authorised representative, the obligations of the manufacturer referred to in no. 4 can be fulfilled by his authorised representative, on his behalf and under his responsibility, if they are set in the order.

ANNEX VII

Module E: related conformity type on the basis of quality assurance to the product



1. conformity with the design on the basis of a quality assurance based on the product is the part of a conformity assessment procedure, in which the manufacturer in the Z meets the 2 and 5 laid down obligations and ensures and declares on its own responsibility that the products concerned conform to the type described in the EU type examination certificate and comply with the applicable requirements of this regulation.

2. making the manufacturer operates a certified quality assurance system for final inspection and testing of the products concerned in accordance with no. 3 and is subject to the surveillance referred to in no. 4.

3. quality system 3.1.
The manufacturer must apply to a notified body of his choice of the assessment of his quality system for the products concerned.

              The application contains the following:



a) name and address of the manufacturer and, if the application is lodged by the authorised representative, also its name and address, b) a written declaration that the same application with any other notified body; filed

c) all relevant information for the product category envisaged, d) documentation on the quality assurance system and e) the technical documentation of the approved type and a copy the EU type examination certificate.

3.2. the quality assurance system ensures conformity of the products with the type described in the EU type examination certificate and with the applicable requirements of this regulation.

All elements considered by the manufacturer, requirements, and provisions are systematically and properly in the form of written policies, to assemble procedures and instructions. This quality assurance system documentation must permit a uniform interpretation of the quality programmes, plans, manual and reports.

                            Contain in particular an adequate description the following points: a) quality objectives and organizational structure, responsibilities and powers of the Executive Board in regard to product quality;

b) investigations carried out after manufacturing and testing;

c) the relevant quality records, such as inspection reports and test data, calibration data, qualification reports of the who in this area employing people, etc., d) funds will be used to monitor the effective operation of the quality assurance system.

3.3. the notified body must assess the quality assurance system, to determine whether it meets the requirements referred to in 3.2 Z.


In each part of the quality assurance system, which complies with the corresponding specifications of the relevant harmonised standard, it comes from a conformity with these requirements.

In addition to experience in quality management systems, at least one member of the audit has experience with the evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this regulation. The audit includes also an inspection visit at the premises of the manufacturer. The audit team reviewed the in Z 3.1 lit. referred e technical documentation, to ensure that the manufacturer able is to identify the relevant requirements of this regulation and making the necessary verifications, to ensure conformity of the product with these requirements.

The decision is notified to the manufacturer. The notification must contain the conclusions of the audit and the reasoned of assessment decision.

3.4. the manufacturer is committed to meet the obligations associated with the approved quality assurance system and ensuring that it is held always correctly and efficiently.

3.5. the manufacturer shall inform the notified body that has approved the quality system of any planned changes of the quality assurance system.

The notified body shall assess all proposed changes and decide whether the modified quality assurance system complies with still referred to Z 3.2 or whether a re-assessment is required.

It announces its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned of assessment decision.

4. surveillance under the responsibility of the notified body 4.1.
The monitoring is to ensure that the manufacturer duly fulfils the obligations arising from the approved quality system.

4.2. the manufacturer grants access to the manufacturing, inspection, testing and storage of the notified body for assessment and provides all necessary documents you to, in particular: a) the documentation concerning the quality assurance system, b) the relevant quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.

4.3. the notified body shall regularly conducts audits to ensure that the manufacturer is maintaining the quality assurance system and applies and passes him a corresponding report.

4.4. Additionally, the notified body the manufacturer may carry out unannounced visits. During these visits, the notified body may, if necessary, carry out product tests or undergo, in order to ensure the proper functioning of the quality assurance system. The notified body shall supply the manufacturer with a report on the visit and in the case of an examination report.

5. CE-marking, EC declaration of conformity and certificate of conformity 5.1.
The manufacturer must affix their identification number to each individual product that is not a component and that matches the models described in the EU type examination certificate and meets the applicable requirements, marking, and - under the responsibility of the notified body referred to in 3.1 Z -.

5.2. the manufacturer issues a written EC declaration of conformity for each product model, which is not a component, and it keeps for ten years after the placing on the market of the product, which is not a component, ready for the market surveillance authorities. Must be drawn from the EU Declaration of conformity was issued which product model.

Any product that is not a component, is accompanied by a copy of the EC declaration of conformity.

5.3. the manufacturer issues a written certificate of conformity for each model of component and holds it for a decade after the placing on the market of the component for the market surveillance authorities. The Declaration of conformity must be drawn for any component model was issued. Each component is attached to a copy of the certificate of conformity.

6 the manufacturer for ten years after the placing on the market of the product for the market surveillance authorities the following documents provides: a) the documentation referred to in 3.1; Z

(b) the information on the amendment in accordance with Z 3.5 in its approved form;

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

7. each notified body shall inform their notifying authority the approval of quality assurance systems that has issued it or withdrawn, and submitted a list of all approvals of quality assurance systems, which has denied, suspended or otherwise restricted their notifying authority at regular intervals or at the request.

Each notified body shall inform the other notified bodies concerning approvals of quality assurance systems, which has denied, suspended, or withdrawn, and prompt approval of quality assurance systems, which has granted them.

8. authorised representative can 3.1, 3.5, 5 and 6 referred to obligations of the manufacturer under the Z of his authorised representative, on his behalf and under its responsibility are met, if they are set in the order.

ANNEX VIII

Module A: internal production control



1. internal production control is the conformity assessment procedure, with which the manufacturer complies with the obligations referred to in the Nos. 2, 3 and 4 and guarantees and on own responsibility declares that the products concerned comply with the applicable requirements of this regulation.

2. technical documentation of the manufacturer creates the technical documentation. On the basis of these documents, it must be possible to evaluate the compliance of the product with the relevant requirements; they must contain a proper risk analysis and evaluation.

In the technical documentation are the applicable requirements list and the draft, to capture the production and the operation of the product, as far as they are for the assessment of relevant. The technical documents contain at least the following elements: a) a general description of the product, b) designs and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;

c) descriptions and explanations that are necessary to the understanding of the said drawings and diagrams and the operation of the product, d) an installation, the harmonised standards, the reference numbers in the official journal of the European Union have been published, fully or in part has been applied are, and, if these harmonised standards were not applied, a description, with the essential health and safety requirements of this regulation which solutions have been complied with , including a statement, which other relevant technical specifications have been applied. The parts which have been applied, in the event of partly applied harmonised standards are given in the technical documentation;

e) the results of the design calculations, examinations carried out, etc., as well as f) test reports.

3. making the manufacturer take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the products with the technical documentation referred to in no. 2, and with the applicable requirements of this regulation.

4. CE marking, EC declaration of conformity and certificate of conformity 4.1.
The manufacturer must affix the CE marking to each individual product that satisfies the applicable requirements of this regulation, and that is not a component.

4.2. the manufacturer issues a written EC declaration of conformity for a product model which is not a component, and it holds together with the technical documentation for 10 years after the placing on the market of the product, which is not a component, ready for the market surveillance authorities. From the EU Declaration of conformity must emerge for which product model, it was issued.

Any product that is not a component, is accompanied by a copy of the EC declaration of conformity.

4.3. the manufacturer issues a written certificate of conformity for each model of component and holds it together with the technical documentation for 10 years after the placing on the market of the component for the market surveillance authorities. The Declaration of conformity must be drawn for what component it was issued. Each component is attached to a copy of the certificate of conformity.

5. authorised representative, the obligations of the manufacturer referred to in no. 4 can be fulfilled by his authorised representative, on his behalf and under his responsibility, if they are set in the order.

ANNEX IX

Module g conformity based on a single audit



1. for compliance on the basis of a single test is the conformity assessment procedure, with which the manufacturer fulfils the obligations laid down in the Nos. 2, 3 and 5 and ensures and declares on its own responsibility, that the the provisions of no. 4 subjected product complies with the requirements of this Regulation applicable to it.

2. technical documents 2.1.

The manufacturer creates the documents and puts them at the disposal of the notified body referred to in no. 4. On the basis of these documents, it must be possible to evaluate the compliance of the product with the relevant requirements; they must contain a proper risk analysis and evaluation. In the technical documentation, perform the applicable requirements and the design, manufacture and operation of the product are to capture, as far as they are for the assessment of relevance. The technical documents contain at least the following elements: a) a general description of the product, b) designs and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;

c) descriptions and explanations that are necessary to the understanding of the said drawings and diagrams and the operation of the product, d) an installation, the harmonised standards, the reference numbers in the official journal of the European Union have been published, fully or in part has been applied are, and, if these harmonised standards were not applied, a description, with the essential health and safety requirements of this regulation which solutions have been complied with , including a statement, which other relevant technical specifications have been applied. The parts which have been applied, in the event of partly applied harmonised standards are given in the technical documentation;

e) the results of the design calculations, examinations carried out, etc., as well as f) test reports.

2.2: the manufacturer must have for ten years the technical documentation for the placing on the market of the product for the market surveillance authorities.

3. manufacture the manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the applicable requirements of this regulation.

4. check leads a notified body chosen by the manufacturer the appropriate investigations and checks according to the relevant harmonised standards or equivalent tests that are listed in other relevant technical specifications. by or may be performed to check 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 what checks are performed.

The notified body shall issue a certificate of conformity on the basis of these examinations and tests and affix its identification number to each approved product or can bring them under their responsibility.

The manufacturer holds the certificates of conformity for ten years after the placing on the market of the product for the market surveillance authorities.

5. CE-marking, EC declaration of conformity and certificate of conformity 5.1.
The manufacturer shall affix the identification number on any product that is not a component and that satisfies the applicable requirements of this regulation, the CE marking and, under the responsibility of the notified body referred to in no. 4.

5.2. the manufacturer a written EU Declaration of conformity and keep for ten years after the placing on the market of the product, which is not a component, ready for the market surveillance authorities. Must be drawn from the EU Declaration of conformity for which product was issued.

Any product that is not a component, is accompanied by a copy of the EC declaration of conformity.

5.3. the manufacturer issues a written certificate of conformity and holds it for a decade after the placing on the market of the component for the market surveillance authorities. The Declaration of conformity must be drawn for what component it was issued. Each component is attached to a copy of the certificate of conformity.

6. authorised representative can 2.2 and 5 referred to obligations of the manufacturer in the Z of his authorised representative, on his behalf and be fulfilled under his responsibility, provided that they are set in the order.

ANNEX X.

EU Declaration of conformity (No. xxxx)



1. product model/product (product, type, batch or serial number): 2. name and address of the manufacturer and, where appropriate, his authorised representative: 3. bears sole responsibility for issuing this Declaration of conformity the manufacturer.

4. object of the Declaration (name of the product for the purpose of traceability: if necessary, an image can be added to the identification of the product.): 5. the above subject to the Declaration complies with the relevant Community harmonisation of the Union: 6 specifying the relevant harmonized standards or other technical specifications, that the Declaration of conformity the basis were: 7 if necessary: the notified body... (Name, number)... has... (Description of measure)... and following certificate issued: 8 additional information: signed for and on behalf of: (place and date of issue): (name, function) (signature):