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

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

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

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

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

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

medical equipment intended for use in medical fields;

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

from which they have obtained a product;

to which they have delivered a product.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

the CE marking has not been affixed;

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

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

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

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

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

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

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

Equipment Group I

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

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

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

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

Equipment Group II

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

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

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

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

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

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

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

Common requirements for equipment and protective systems

General requirements

Principles of integrated explosion safety

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

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

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

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

Special testing and maintenance conditions

Environment conditions

Marking

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

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

the name of the series and the type,

where appropriate, the batch or serial number,

the year of construction,

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

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

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

Operating Instructions

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

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

Information on or on the safe

Commissioning,

use,

assembly and disassembly,

maintenance (maintenance and fault management),

Equipping;

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

where necessary, information on the training;

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

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

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

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

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

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

Selection of materials

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

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

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

Construction and construction

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

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

Closed construction and prevention of leaks

Dust deposits

Additional protective measures

Unsafe Open

Protection against other risks

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

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

experience shows that non-electrical hazards are excluded;

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

Device overload

Pressure-resistant encapsulation devices

Potential sources of ignition

Hazards due to different ignition source types

Hazards due to static electricity

Hazards due to electrical stress and leakage currents

Hazards caused by inadmissible warming

Pressure balancing hazards

Hazards caused by external interference

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

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

Requirements for safety devices

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

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

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

Operating and display devices

Requirements for devices with a measuring function for explosion protection

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

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

Risk through software

Integration of safety-related system requirements

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

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

Hazards caused by power failure

Ports driven

Arrangement of warning devices as part of a device

More stringent requirements for equipment

Requirements for equipment of device group I

Requirements for equipment category M 1 of equipment group I

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

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

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

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

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

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

Requirements for equipment category M 2 of equipment group I

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

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

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

Equipment category 1 requirements of device group II

Explosive atmospheres caused by gases, vapors or fog

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

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

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

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

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

Explosive atmosphere due to dust/air mixtures

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

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

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

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

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

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

Equipment category 2 requirements of device group II

Explosive atmospheres caused by gases, vapors or fog

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

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

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

Explosive atmosphere due to dust/air mixtures

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

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

With regard to dust protection, requirement 2.1.2.2 shall apply.

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

Requirements for equipment category 3 of equipment group II

Explosive atmospheres caused by gases, vapors or fog

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

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

Explosive atmosphere due to dust/air mixtures

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

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

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

More stringent requirements for protection systems

General requirements

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

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

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

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

Project planning and planning

Material properties

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

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

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

Discharge facilities

Explosion suppression systems

Explosion-oriented decoupling systems

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

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

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

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

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

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

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

a general description of the product,

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

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

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

the results of design calculations, tests, etc. and

the audit reports

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

The notified body shall carry out the following tasks:

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

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

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

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

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

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

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

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

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

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

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

Manufacture

Quality assurance system

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

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

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

all relevant information relating to the product category envisaged;

the documents relating to the quality system;

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

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

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

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

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

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

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

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

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

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

Monitoring under the responsibility of the notified body

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

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

the documents relating to the quality system;

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

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

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

CE marking, EU declaration of conformity and certificate of conformity

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

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

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

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

the documents referred to in Z 3.1;

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

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

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

Authorised representative

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

Manufacture

Review

Verification of conformity by examination and testing of each product

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

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

CE marking, EU declaration of conformity and certificate of conformity

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

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

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

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

Authorised representative

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

Manufacture

Product Checks

CE marking, EU declaration of conformity and certificate of conformity

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

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

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

Authorised representative

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

Manufacture

Quality assurance system

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

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

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

all relevant information relating to the product category envisaged,

the documents relating to the quality system and

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

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

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

studies and tests carried out after manufacture;

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

Means to monitor the effective functioning of the quality system.

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

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

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

Monitoring under the responsibility of the notified body

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

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

the documents relating to the quality system,

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

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

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

CE marking, EU declaration of conformity and certificate of conformity

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

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

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

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

the documents referred to in Z 3.1;

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

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

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

Authorised representative

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

Technical documentation

a general description of the product,

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

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

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

the results of design calculations, tests, etc. and

the audit reports.

Manufacture

CE marking, EU declaration of conformity and certificate of conformity

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

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

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

Authorised representative

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

Technical documentation

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

a general description of the product,

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

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

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

the results of design calculations, tests, etc. and

the audit reports.

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

Manufacture

Review

CE marking, EU declaration of conformity and certificate of conformity

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

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

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

Authorised representative

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

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

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

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

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

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

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

Additional information: