Conformity Assessment Of Equipment In Potentially Explosive Atmospheres

Original Language Title: posuzování shody zařízení v prostředí s nebezpečím výbuchu

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116/2016 Sb.



GOVERNMENT REGULATION



of 30 March 2004. March 2016



on conformity assessment of equipment and protective systems intended for use in

potentially explosive atmospheres when the supply on the market



The Government directs pursuant to § 4 and § 50 para. 5 of law No. 90/2016 Coll.

conformity assessment of specified products when they are making available on the market (hereinafter

"the Act"):



§ 1



The subject of the edit



(1) this regulation incorporates the relevant provision of the European Union ^ 1) and

regulates the technical requirements for equipment and protective systems intended for

use in potentially explosive atmospheres, which must be fulfilled in

placing on the market, the conditions and procedures for their making available on the market or

putting into use and conformity assessment methods.



(2) this Regulation applies to the following products for conformity assessment

pursuant to section 4 of the Act (hereinafter referred to as "products"):



and) equipment and protective systems intended for use in an environment with

potentially explosive atmosphere,



b) safety, control and regulation devices that are designed to

use outside potentially explosive atmospheres but are necessary for the

the safe functioning of the products or their contributing, and



c) parts intended to be incorporated into products.



(3) this Regulation shall not apply to:



and) medical devices intended for use in a medical environment,



b), equipment and protective systems where the explosion hazard results only

from the presence of explosives or chemically unstable substances,



c) equipment intended for use in private households and the environment that is not

intended for business, where potentially explosive atmospheres may create

only in exceptional cases only as a result of accidental leakage of fuel gas,



d) personal protective equipment the conformity of which is assessed by another

Law ^ 2)



e) seagoing vessels and mobile offshore objects, including installations for the

Board these vessels or objects,



f) means of transport which are intended solely for the carriage of

of passengers by air, road or rail or by waterway,

as well as means of transport intended for transporting goods by air, the public

road or rail or by waterway, with the exception of vehicles

intended for use in potentially explosive atmospheres, and



g) device used for the manufacture of weapons, ammunition or military

material.



§ 2



Definition of terms



In this regulation means



and also by the manufacturer) a person who manufactures a product or has a product

designed or manufactured, and this product is used for its own account,



(b)) device, machines, apparatus, fixed or mobile devices, control

components and Instrumentation thereof and detection or prevention

protective systems which are intended for the generation, transfer, storage,

measurement, control and conversion of energy and/or the processing of material and which

are capable of causing an explosion through their own potential

source of ignition;



(c)) of the device other than the protective systems components, which are

intended to suppress incipient explosions or to

restriction of the scope of the effects of an explosion and which are separately placed on the market

and used as independent systems,



d) components of the elements that are important for the safe operation of the equipment

and protective systems but with no autonomous function,



e) explosive atmospheres mixture of flammable substances in the form of gases, vapours, mists

or dust with air, under atmospheric conditions, in which, after

ignition, combustion spreads to the entire unburned mixture,



f) environment with danger of explosion of the environment that may become

explosive due to local and operational conditions,



g) equipment-group I equipment intended for use in underground parts of

down and those parts of surface installations of such mines, liable to be

endangered by firedamp and/or combustible dust, including category

device M 1 and M 2, set out in annex 1 to this regulation,



h) equipment-group II, equipment intended for use in other locations,

which may be endangered by explosive atmospheres, including category

device 1, 2 and 3, as set out in annex 1 to this regulation,



I) device categories, classification of equipment within each group

the equipment provided for in annex 1 to this regulation and defining the

the level of protection, which must be guaranteed,



j) intended use use of the product prescribed by the manufacturer by incorporating

of the device to the equipment group and category-specific or

by providing all the information that are necessary for the safe

the functioning of the protective system, device, or component.



§ 3



Technical requirements for products



Basic technical requirements for products are the basic requirements for

health and safety requirements set out in annex 2 to this regulation.

Meet the essential technical requirements shall be demonstrated by assessing

of conformity.



§ 4



Making available on the market and putting into service



(1) the products may be placed on the market and put into service only if,

If provided proper installation, maintenance and use of the specified

the purpose of the requirements of this regulation are met.



(2) for trade fairs, exhibitions and similar demonstrations can be shown off

products which are not in conformity with this regulation, if it is of

clear visible sign that these products are not in conformity with this

Regulation and cannot be placed on the market and put into service until

the manufacturer does not match. Demonstrations must be taken

security measures to ensure the protection of persons.



§ 5



The manufacturer of the



(1) when placing their products on the market or use for their own

the need for a manufacturer shall ensure that these products have been designed and manufactured in

accordance with the basic technical requirements, shall establish the technical

documentation set out in annexes 3 to 9 of this regulation and

carry out or have carried out the conformity assessment procedure in accordance with § 10.



(2) if compliance with the basic technical requirements to the procedure

assessment of conformity, the manufacturer shall draw up the evidence



and the product) is not part of, EU Declaration of conformity and affix the

CE marking and product



(b)) to the components of a written certificate of conformity in accordance with section 10, paragraph 1. 3.



(3) the manufacturer shall keep the technical documentation and Declaration of conformity EU

or a certificate of conformity for a period of 10 years after placing the product on the market.



(4) the manufacturer shall ensure that the products placed on the market, stated

the number of the batch or serial number or other element allowing their

identify or, in cases where the size or nature of the product

does not allow it, that the required information is provided on the packaging or in

a document accompanying the product. For products placed on the market by the manufacturer and

that are not part of, the manufacturer shall ensure that bear the special mark

explosion protection and, where appropriate, other markings and information set out in

point 1.0.5 of annex 2 to this regulation.



(5) the manufacturer shall indicate on a product in a language comprehensible to the final users

and of the supervisory authority, or, if this is not possible, on its packaging or in a document

accompanying the product in your name or business name, or trade

mark, and the address for service. Delivery address must be the address

the place in which the manufacturer can be actually reach you.



(6) the manufacturer shall ensure that each product is accompanied by a copy of the EU

Declaration of conformity or the certificate of conformity. In cases where one

the end user adds more products at a time, can be

the batch or consignment provided with a single copy of this document.

The manufacturer shall ensure that the product is accompanied by a clear and understandable

instructions and safety information in Czech language.



(7) the manufacturer shall carry out in order to protect the health and safety of the final

users sample testing of marketed products and other necessary

the investigation, if it is necessary in view of the risks which the product

represents. These tests and the investigation is carried out to the extent necessary for the

the confirmation or refutation of the risk posed by the product due to the

by the manufacturer, its intended purpose of use. The producer keeps records of complaints,

non-compliant products and products which pulled out of circulation, and continuously about

inform distributors.



§ 6



Authorized representative



Authorised representative shall keep the EU Declaration of conformity or a certificate of

conformity and the technical documentation for the requirements of a supervisory authority for 10 years

by placing the product on the market.



§ 7



The importer



(1) before placing the product on the market importers shall ensure that the manufacturer has made

the conformity assessment procedure referred to in article 10, has drawn up a technical

documentation, that the product or carried the CE mark, so that it was

accompanied by an EU Declaration of conformity or the certificate of conformity and the required

documents and that the manufacturer has complied with the requirements set out in § 5 para. 4 and 5.



(2) the importer shall ensure that the product is accompanied by instructions and safety

the information in the Czech language.



(3) the importer for a period of 10 years after placing the product on the market keeps a copy of the EU

Declaration of conformity or the certificate of conformity at the disposal of the supervisory authority and the

ensures that the supervisory authority was at his request, submitted to the technical

documentation.



(4) the importer shall indicate on the product in a language comprehensible to the final users


and of the supervisory authority, or, if this is not possible, on its packaging or in a document

accompanying the product in your name or business name, or trade

mark, and the address for service.



(5) the importer performs in order to protect the health and safety of the final

users sample testing of marketed products and other necessary

the investigation, if it is necessary in view of the risks which the product

represents. These tests and the investigation is carried out to the extent necessary for the

the confirmation or refutation of the risk posed by the product due to the

by the manufacturer, its intended purpose of use. The importer keeps records of complaints,

non-compliant products and products which pulled out of circulation, and continuously about

inform distributors.



§ 8



Distributor



The Distributor before you ship the product on the market shall verify that



and) the product carries the CE marking, if required,



(b)) is accompanied by an EU Declaration of conformity or the certificate of conformity

and the required documents and instructions and safety information in Czech language

and



(c) manufacturers and importers meet) the requirements set out in § 5 para. 4 and 5, and in the

§ 7 para. 4.



§ 9



Time to identify the operator



Economic operator for a period of 10 years from the delivery of the product on the market shall keep

data that can be used at the request of the supervisory authority to determine the economic

the body, which he has supplied or the product to which the product, he added.



§ 10



The conformity assessment procedures



(1) the conformity of the equipment and, if necessary, devices

referred to in § 1 (1). 2 (a). (b)), the following procedures shall apply:



and equipment) for groups I and II, equipment category M 1 and 1, the procedure of the EU

type-examination (module B) as set out in annex 3 to this regulation,

in conjunction with one of the following procedures:



1. conformity to type based on quality assurance of the production process

(module D) indicated in annex 4 to this regulation, or



2. conformity to type based on product verification (module F) as provided for in

Annex 5 to this regulation,



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



1. in the case of internal combustion engines and electrical equipment in these groups and

categories of EU type-examination procedure (module B) indicated in annex No. 3

This regulation, in combination with one of these procedures:



1.1. the conformity to type based on internal production control and testing

products under the supervision of (module C1) set out in Appendix 6 to this

Regulation, or



1.2. the conformity to type based on product quality assurance (module E)

laid down in annex 7 to this regulation,



2. in the case of other equipment in these groups and categories, internal production control

(module A) set out in annex 8 to this regulation and pass

the technical documentation referred to in point 2 of Annex 8 to this regulation

the notified body, that without undue delay shall acknowledge receipt and

documentation shall be retained,



(c)) for equipment group II, equipment category 3, internal production control

(module A) set out in annex 8 to this regulation,



(d)) for device groups I and II can be used in addition to the procedures referred to in letters a, b))

or (c)) also use the conformity based on unit verification

(module G) laid down in annex 9 to this regulation.



(2) protective systems for conformity assessment shall follow the procedures referred to in

paragraph 1 (b). and) or (d)).



(3) the procedures referred to in paragraph 1 shall also apply to the component, with the exception of

the location of the CE marking and drawing up EU Declaration of conformity. The manufacturer shall issue a

a written certificate of conformity, which declares the conformity of the components with the requirements of

laid down in this regulation and which indicates their characteristics and

how they must be incorporated into equipment or protective systems

in order to meet the basic technical requirements that apply to

finished equipment or protective systems.



(4) as regards safety aspects laid down in point 1.2.7 of Annex No.

2 this regulation is in addition to the conformity assessment procedures referred to in

paragraphs 1 and 2 can also use the procedure set out in annex 8 to

application of this regulation.



(5) the Documents and correspondence relating to conformity assessment procedures

referred to in paragraphs 1 to 4 shall be drawn up in the English language.



§ 11



Presumption of conformity



(1) if the product is in conformity with harmonised standards or their

parts of the product concerned and the links which have been published in the

The official journal of the European Union, it is considered that it is in compliance with

basic technical requirements covered by those standards or their

section applies.



(2) in the absence of harmonised standards, the technical authority shall publish

Standardization, metrology and testing (hereinafter referred to as "the authority") in

Journal of the Office information on the existing Czech technical standards and

other documents which prescribe the technical requirements which has

the product must meet the (hereinafter referred to as "technical specifications"), which are

considered suitable for the correct implementation of the basic technical

requirements.



§ 12



EU Declaration of conformity



(1) the EU Declaration of conformity shall state that the fulfilment of has been shown to

the basic technical requirements.



(2) the EU Declaration of conformity shall be drawn up in accordance with the model set out in

Annex 10 to this regulation, shall contain the elements specified in the procedures

conformity assessment provided for in annexes 3 to 9 of this regulation and

must still be updated. EU Declaration of conformity shall be translated into

the language or languages required by the Member State of the European Union, in which

the product is placed or made available on the market.



(3) If the product is subject to more rules of the European harmonisation

the Union setting out the elaboration of EU Declaration of conformity,

a single EU Declaration of conformity with links to all of these regulations, including

links to their publication. This single EU Declaration of conformity can be

the form of a folder consisting of declarations of conformity issued to individual

the legislation.



section 13 of the



Affixing the CE marking, identification number of notified bodies and

other markings



(1) the CE marking, which is placed before placing the product on the market,

placed on a product or to its data plate. If due to the nature of the

It is not possible or not warranted on the product, the CE marking shall be placed on the packaging and

the accompanying documents.



(2) the identification number of the notified body involved

the assessment of conformity to type based on quality assurance of the production

the process set out in annex 4 to this Regulation (module D)

the assessment of conformity to type based on product verification provided for in

Annex 5 to this Regulation (module F), the assessment of conformity with the type

based on quality assurance of the products set out in annex 7 to the

This Regulation (module E) or conformity assessment based on authentication

each individual product as set out in annex 9 to this regulation

(module G), connects for the CE marking, the notified body or by its

the instructions of the manufacturer or his authorised representative.



(3) the CE marking, and, where appropriate, the identification number of the notified

following are subject specific marking of explosion protection (see fig.)

brand equipment group and category, and possibly other markings and information

laid down in point # 2 1.0.5 of annex to this regulation.



(4) the CE marking and designations, tags and data referred to in paragraph

3, where appropriate, for the identification number of the notified body, may be

placed any other mark indicating a special risk or use.



(5) products, which are designed for a particular explosive atmosphere must be

marked accordingly.



§ 14



Formal defects



A formal deficiency is considered when



and) the CE marking was placed in breach of article. 30 of the regulation of the European

Parliament and of the Council (EC) no 765/2008, laying down the requirements for the

accreditation and market surveillance relating to the marketing of products on the market and

repealing Regulation (EEC) No 339/93, with section 15 of the Act or section 13 of the

paragraph. 1,



(b)) the CE marking, if required, has not been located,



(c)) the specific marking of explosion protection (see fig.), tags and groups

device categories and other markings and information have been placed in conflict with

point # 2 1.0.5 of annex to this regulation or have not been located,



(d) the identification number of the notified body) were placed in violation of §

13 or not located,



(e)) the product is not accompanied by a certificate of conformity to the EU or, where appropriate,

certificate of conformity



(f)), the EU Declaration of conformity or the certificate of conformity, where applicable, has not been

drawn up in accordance with this regulation,



g) technical documentation is missing or incomplete,



(h)), the information specified in § 5 para. 5 or § 7 para. 4 is missing or

incorrect or incomplete, or



I) was not fulfilled other administrative requirement referred to in section 6 of the Act

or in section 8 of the Act or in section 5, or section 7.



§ 15



Transitional provisions



(1) products complying with the requirements fixed by regulation of the Government No. 23/2003

Coll., laying down technical requirements for equipment and protective

systems intended for use in potentially explosive atmospheres, can be

continue to be made available on the market and put into service if they have been placed on the market

before the date of entry into force of this regulation.



(2) valid certificates and other documents that certify the detected

the facts that have been issued by a notified persons under regulation


No. 23/2003 Coll., shall remain in force and shall be deemed

certificates and other documents under this regulation.



section 16 of the



Regulation (EEC)



Government Regulation No. 23/2003 Coll. laying down technical requirements for

equipment and protective systems intended for use in potentially

the explosion, is hereby repealed.



§ 17



The effectiveness of the



This Regulation shall enter into force on 20 March 2004. April 2016.



Prime Minister:



Mgr. Sobotka in r.



Minister of industry and trade:



Ing. Mládek, CSc., r.



Č. 1



CRITERIA FOR THE CLASSIFICATION OF THE DEVICE GROUPS INTO CATEGORIES



1. Equipment-Group I



and M device) category 1 comprises equipment designed and, in

If necessary, additionally equipped with special means of protection,

to be capable of functioning in conformity with the operational parameters established

by the manufacturer and ensuring a very high level of protection.



Equipment in this category is intended for use in underground parts of mines

and those parts of surface installations of such mines, which are vulnerable to

firedamp and/or combustible dust.



Equipment in this category must remain functional in explosive environments and

the event of rare incidents relating to equipment, in particular, must be

equipped with means of protection such that



1. in the event of failure of one means of protection to ensure the desired

level of protection at least 1 additional independent means of protection, or



2. the required level of protection be ensured even in the event the formation of two

independent failures.



Equipment in this category must comply with the additional requirements set out in

section 2.0.1 of annex 2 to this regulation.



b) category M 2 comprises equipment designed

to be capable of functioning in conformity with the operational parameters established

by the manufacturer and ensuring a high level of protection.



Equipment in this category is intended for use in underground parts of mines

and those parts of surface installations of such mines, liable to be

endangered by firedamp and/or combustible dust.



These devices must be in the event of an explosive atmosphere is turned off from the

the network.



The means of protection relating to equipment in this category provide

the requisite level of protection during normal operation and in case of more severe

operating conditions resulting from, in particular, rough treatment and changes in

the surrounding environment.



Equipment in this category must comply with the additional requirements set out in

point of Annex No. 2 2.0.2.



2. the device group II



and Category 1 comprises equipment) devices that are designed to

be capable of functioning in conformity with the operational parameters established

by the manufacturer and ensuring a very high level of protection.



Equipment in this category is intended for use in areas in which

is permanently, for long periods or often explosive atmospheres

gases, vapours or mists or air/dust mixtures.



Equipment in this category must ensure the requisite level of protection, even in the

the event of rare incidents relating to equipment, in particular, must be

equipped with means of protection such that



1. in the event of failure of one means of protection to ensure the desired

level of protection at least 1 additional independent means of protection, or



2. the required level of protection be ensured even in the event the formation of two

independent failures.



Equipment in this category must comply with the additional requirements set out in

point 2.1 of the annex 2 to this regulation.



(b) Category 2 comprises equipment) devices that are designed to

be capable of functioning in conformity with the operational parameters established

by the manufacturer and ensuring a high level of protection.



Equipment in this category is intended for use in areas in which

It is likely the occasional formation of an explosive atmosphere of gas,

vapours, mists, or air/dust mixtures.



The means of protection relating to equipment in this category provide

the required level of protection in the event of frequently occurring disturbances or

the failure of the unit, which should be normally count on.



Equipment in this category must comply with the additional requirements set out in

section 2.2 of annex 2 to this regulation.



c) device category 3 comprises equipment designed to

be capable of functioning in conformity with the operational parameters established

by the manufacturer and ensuring a normal level of protection.



Equipment in this category is intended for use in areas in which

It is not likely the formation of an explosive atmosphere of gases, vapours,

mists or air/dust mixtures, if they do occur,

This is probably only rarely and only for a short period of time.



Equipment in this category provide the desired level of safety in

normal operation.



Equipment in this category must comply with the additional requirements set out in

section 2.3 of annex 2 to this regulation.



Č. 2



THE BASIC REQUIREMENTS FOR HEALTH AND SAFETY RELATING TO THE DESIGN AND

CONSTRUCTION OF EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN AN ENVIRONMENT

POTENTIALLY EXPLOSIVE ATMOSPHERE



Introductory notes



A. you need to take into account the technological knowledge, and shall

take advantage of.



(B). The instruments referred to in § 1 (1). 2 (a). (b)), the basic requirements for

health and safety apply only to the extent in which they are

necessary for their safe and reliable functioning and operation with a view

the risk of explosion.



1. Common requirements for equipment and protective systems



1.0 General requirements



comprehensive safety principles in terms of explosion



Equipment and protective systems intended for use in potentially

explosion must be designed with regard to the safety of the

explosion.



Therefore, the manufacturer shall take steps to



and) prevent, if possible, creating an explosive environment

This may occur in the equipment or protective systems or

of them spread,



b) prevent the ignition of explosive atmospheres, taking account of the characteristics of the

all the electrical and non-electrical sources of ignition,



(c)) was immediately suppressed or that the range of explosion

flames and explosion pressures to a sufficient level of safety,

If an explosion nevertheless occur which could directly or indirectly

endanger persons and, where appropriate, domestic animals or property.



1.0.2. equipment and protective systems must be designed and manufactured after

due analysis of possible operating faults in order as far as possible

to preclude dangerous situations.



It is necessary to take into account any reasonably foreseeable misuse thereof.



1.0.3. Special conditions for inspection and maintenance



Equipment and protective systems subject to special conditions

checks and maintenance, must be designed and constructed with regard to these

terms and conditions.



1.0.4 ambient conditions



Equipment and protective systems must be designed and constructed so that the

be capable of coping with actual or foreseeable conditions

environment.



1.0.5. Marking



On equipment and protective systems must be marked legibly and indelibly

way marked at least the following information:



and) the name, business name or trade mark and address of the manufacturer,



(b)) the CE marking (see annex II to Regulation (EC) no 765/2008),



(c)) designation of series or type,



d) batch number or serial number, if any,



e) year of manufacture,



(f)) the specific marking of explosion protection (see fig.) followed by

brand of the equipment group and category,



g) for equipment group II, the letter ' G ' (concerning explosive atmospheres caused by

gases, vapours or mists), or



(h)), the letter "D" (for explosive atmospheres caused by dust).



On equipment and protective systems must be further if necessary

be marked with all the information relevant to the safe use of the equipment and

protective systems.



1.0.6 instructions for use



and) to each device and protective system must be accompanied by instructions for

containing at least the following information:



1. Summary of the information on the equipment or protective system with

the exception of lot numbers or serial numbers, together with all the

information to facilitate maintenance (e.g. address of the repair shops),



2. instructions for the



2.1 safe entry into service,



2.2 the safe use,



2.3 safe Assembly and disassembly,



2.4 safe maintenance (preventive maintenance and troubleshooting)



2.5 safe installation,



2.6 safe adjustment,



3. If desired, the designation of the affected areas before the devices for

release of pressure,



4. If necessary, instructions for the training,



5. details that will allow to clearly decide whether the device

a certain category or a protective system can be expected

operating conditions in the area considered safe to use,



6. electrical and pressure parameters, maximum surface temperature and more

the limit values,



7. where necessary, special conditions of use, including details about the

possible misuse which experience has shown might occur,



8. where necessary, the essential characteristics of tools which can be used to

the equipment or protective system.



(b)) instructions must contain the drawings and diagrams necessary for putting into


service, maintenance, inspection, checking of correct operation and, where appropriate, for

repair of the equipment or protective system and instructions on how to

safety.



c) Literature describing the equipment or protective system must not, if

refers to safety aspects, in violation of the instructions.



1.1 material selection



1.1.1. The materials used in the manufacture of equipment and protective systems must not

cause an explosion taking into account foreseeable operational stresses.



1.1.2. In the range of operating conditions laid down by the manufacturer, shall not be

the materials used and the constituents of the potentially explosive atmosphere

the reaction, which could impair explosion protection.



1.1.3. materials must be so selected that predictable changes in their

characteristics and their compatibility in combination with other materials will not lead to a reduction in

the protection granted, in particular, due attention must be paid to

the material's corrosion and wear resistance, electrical

conductivity, mechanical strength, ageing resistance and the effects of

temperature changes.



1.2 design and construction



1.2.1. equipment and protective systems must be designed and constructed with the

due regard to technological knowledge in the field of protection against

the blast so that they can be safely operated throughout its

expected life-span.



1.2.2. the Parts intended to be incorporated into the equipment and protective systems

or for use as spare parts for equipment and protective systems must

be designed and constructed so that after the installation according to the instructions of the manufacturer

they function safely for their protection against explosion.



1.2.3. Enclosed structures and prevention of leaks



The device from which may release flammable gases or dusts

You must use only the enclosed structures where possible.



If equipment contains openings or non-tight joints, these must as far as possible

designed in such a way that releases gases or dust could not

create explosive atmospheres outside the equipment.



Points where materials are introduced or of materials

be taken, shall be designed and equipped so that when the

filling or emptying of the restricted leakage of flammable materials.



1.2.4. Dust deposits



Equipment and protective systems which are intended for use in dusty

the environment must be designed that deposit dust on their

surfaces is not ignited.



In General, there is a need to limit dust accumulation, where this is possible. Equipment and

protective systems must be easy to clean.



The surface temperatures of equipment parts must be kept sufficiently low

under the temperature of doutnání dust.



It is necessary to take into account the thickness of the layer of dust, and in the case of

the need to adopt measures to reduce the temperature, to prevent heating

This layer.



1.2.5. Additional means of protection



Equipment and protective systems which may be exposed to certain types of

of external stresses must be fitted with additional, if needed

means of protection.



The equipment must withstand relevant stresses without any negative impact on the

explosion protection.



1.2.6. Safe opening



If equipment and protective systems stored in a protective housing or in the

custom enclosed forming part of the explosion protection must

be able to open this cover or sleeve only instrumental

specified, or with the use of appropriate protective measures.



1.2.7. Protection against other hazards



Equipment and protective systems must be so designed and manufactured as to:



a) avoid physical injury or other harm which might be

caused by direct or indirect contact,



(b)) to ensure that the accessible parts there is no formation of

surface temperatures or radiation, which could be a source of danger,



(c)) was excluded non-electrical hazards that may experience

arise,



d) assure that foreseeable conditions of overload shall not arise

other hazards.



If equipment and protective systems for the danger referred to in

This point fully or partly covered by other regulations of the European Union, this

the regulation does not apply or cease to apply to the equipment and protective

systems and the danger to which they shall apply those provisions of the European

Union.



1.2.8. Overloading of equipment



Dangerous overloading of equipment must be prevented at the design stage using

integrated measurement, regulation and control devices, such as

over-current cut-off switches, temperature limiters, differential pressure switches,

flow meters, time delay relays, control tachometers and similar types of

monitoring devices.



1.2.9. flameproof Systems



If parts which can ignite an explosive atmosphere in the hard

the conclusion, measures must be taken to ensure that the conclusion of the resisted

the pressure arising from the explosion of an explosive mixture and prevents the

transmission of the explosion to the explosive atmosphere that surrounds the conclusion.



1.3. Potential ignition sources



1.3.1. hazards arising from different ignition sources



Must be excluded potential ignition sources such as sparks,

flames, electric arcs, high surface temperatures, acoustic

energy, radiation in the visible spectrum, electromagnetic waves and other

the source of ignition.



1.3.2. hazards arising from static electricity



It should be the appropriate means to prevent electrostatic charges

capable of resulting in dangerous discharges.



1.3.3. hazards arising from stray electric and leakage currents



In conductive equipment parts is necessary to prevent

diffusing stray electric and leakage currents, which could lead, for example, to

the emergence of dangerous corrosion, overheating of surfaces or sparks capable of

cause ignition.



1.3.4. hazards arising from overheating



In the design phase, it should be possible to prevent overheating caused by

friction or impacts occurring, for example, between materials and parts that are

get in contact at the rotation, or the intrusion of foreign bodies.



1.3.5. hazards arising from pressure-balanced



Equipment and protective systems must be so designed or fitted with

integrated measuring, control and regulation devices that when

by balancing pressure compensations arising from waves

compressions which may cause ignition.



1.4. hazards arising from external effects



1.4.1. Equipment and protective systems must be so designed and constructed as

to be able to carry out their function in full safety, even in

changing environmental conditions and in the presence of extraneous voltages,

humidity, vibrations, contamination and other external influences in the range

operating conditions laid down by the manufacturer.



1.4.2. Equipment parts used must be appropriate to the intended

mechanical and thermal stresses and capable of withstanding attack

aggressive substances.



1.5 requirements for safety devices



1.5.1 Safety devices must function independently of the measuring and

control devices required for operation.



Failure of a safety device must be recorded with the appropriate

technical means if possible, fast enough, to make it

to ensure that it will be only a very small probability of dangerous

situations.



Safety switch-off and switch-on must directly act on the relevant

control devices without intermediate software command.



1.5.2. In case of failure of a safety device or the device must be

protective system, wherever possible, to a safe state.



1.5.3. Emergency stop controls of safety devices must, as far as possible

fitted with restart lockouts. New command to run may lead

to begin normal operation only if the screen was

recovery run intentionally to its original state.



1.5.4. Control and display units



Where control and display units, must be designed in

accordance with ergonomic principles in order to achieve the highest possible level of

operational safety in terms of the risk of explosion.



1.5.5. Requirements for devices with a measuring function for explosion protection



Devices with a measuring function, that affect the equipment used in the

explosive atmospheres must be designed and constructed in accordance with the

all the operating requirements and special conditions of use.



1.5.6. Where necessary, it shall be possible to verify the accuracy of the data and

the serviceability of devices with a measuring function.



1.5.7. The design of devices with a measuring function must incorporate a safety

factor which ensures that the alarm threshold lies out of bounds

explosion and ignition limits of the environment that the device registers,

particular with regard to the operating conditions of the installation and possible aberrations

the measuring system.



1.5.8. Risks due to software



When designing equipment, protective systems, or safety devices

controlled software must be paid special attention to the analysis of

danger caused by errors in the program.



1.6. Integration of safety requirements relating to the system



1.6.1. To shut down the equipment and protective systems incorporated within

automatic processes which deviate from the intended must be operational

conditions exist the possibility of manual control, if it does not threaten


safety.



1.6.2. If included in the emergency shutdown system, it must be

the accumulated energy as quickly and as safely as possible or

isolated so that it no longer constitutes a hazard.



This requirement does not apply to electrochemically accumulated energy.



1.6.3. hazards arising from power failure



In the case of equipment and protective systems which may have a disorder

power supply gives rise to a further risk, it must be possible to maintain

their safe operating status independently of the rest of the entire device.



1.6.4. hazards arising from connections



Equipment and protective systems must be fitted with suitable cable

glands, and inputs for pipe lines.



If equipment and protective systems intended for use in combination with

other devices and protective systems must be their link

carried out in a safe manner.



placing of warning devices as parts of equipment



Where equipment or protective systems are fitted with detection or

alarm devices for monitoring the occurrence of explosive atmospheres, must

be accompanied by the necessary instructions for the placement of these devices at the appropriate

places.



2. Additional requirements for equipment



2.0 requirements for devices and device groups



the requirements on the device category to 2.0.1, the M1 device groups and



equipment must be so designed and constructed that sources of

ignition could not activate even if exceptional events

relating to equipment.



The device must be equipped with means of protection such that:



and) in case of failure one of the means of protection provides the requisite

level of protection, at least an independent means of protection, or



(b) the required level of protection) is ensured even in the event of two

independent failures.



If necessary, the device must be equipped with additional special

a means of protection.



The device must remain functional even in an explosive atmosphere.



2.0.1.2 where necessary, equipment must be so designed that the

It could not penetrate the dust.



2.0.1.3 of equipment parts must be kept

sufficiently below the ignition temperature of the foreseeable air/dust

mixtures in order to prevent the ignition of suspended dust.



2.0.1.4 equipment must be designed so that the piece of equipment that can

be sources of ignition is possible only under non-voltage or

for intrinsically safe conditions. If it is not possible to bring the device to the

the status of the power supply must be fitted with a warning device, part of the pop-up

label.



Where necessary, equipment must be provided with the appropriate additional

locking systems.



the requirements for the category of the device 2.0.2 M2 of equipment-group I



equipment must be equipped with means of protection, ensuring

that sources of ignition do not become active during normal operation or when the

severe operating conditions, in particular when

rough handling and changing environmental conditions.



The device must be in the event of an explosive atmosphere off of

the network.



2.0.2.2. Equipment must be so designed that part of the equipment that can

be sources of ignition is possible only under non-voltage or

via appropriate interlocking systems. If it is not possible to give

device to zero voltage, must be part of a device equipped with a pop-up

a warning label.



2.0.2.3 requirements relating to dust explosion hazards laid down for

the device category M1 apply to device category M2, mutatis mutandis.



2.1 requirements for the equipment category 1 of equipment-group II



explosive environment created by gases, vapours or mists



2.1.1.1. Equipment must be so designed and constructed that sources of

ignition could not activate even if exceptional events

relating to equipment.



The device must be equipped with means of protection such that:



and) in case of failure one of the means of protection provides the requisite

level of protection, at least an independent means of protection, or



(b) the required level of protection) is ensured even in the event of two

independent failures.



2.1.1.2. For equipment with surfaces which may heat up, they must be adopted

measures to ensure that the stated maximum surface temperatures are not

exceeded even under the most unfavourable conditions.



It is necessary to take into account also the temperature rises caused by heating and

chemical reactions.



2.1.1.3. Equipment must be so designed that part of the equipment that can

be sources of ignition is possible only under non-voltage or

for intrinsically safe conditions. If it is not possible to bring the device to the

the status of the power supply must be fitted with a warning device, part of the pop-up

label.



Where necessary, equipment must be provided with the appropriate additional

locking systems.



2.1.2. Explosive environment created by air/dust mixtures



2.1.2.1. Equipment must be so designed and constructed that ignition of

present air/dust mixtures avoid even in the event of rare incidents

relating to equipment.



The device must be equipped with means of protection such that:



and) in case of failure one of the means of protection provides the requisite

level of protection, at least an independent means of protection, or



(b) the required level of protection) is ensured even in the event of two

independent failures.



2.1.2.2. Where necessary, equipment must be so designed that dust

the device could enter or escape from it only in those places specifically

intended.



This requirement must also comply with the cable glands and fittings.



2.1.2.3. The surface temperatures of equipment parts must be kept well

below the ignition temperature of the foreseeable air/dust mixtures in order to

prevent the ignition of suspended dust.



2.1.2.4 For the safe opening of equipment parts, requirement point

2.1.1.3.



2.2 requirements for category 2 of equipment-group II



explosive atmospheres caused by gases, vapours or mists



2.2.1.1. the devices must be designed and constructed so that the

prevent foreseeable ignition sources even in the event of frequently occurring disturbances

or equipment operating faults which normally have to be reckoned with.



2.2.1.2. the parts of the equipment must be designed and constructed so as to

they laid down the maximum surface temperatures are not exceeded, even in the

the case of the dangers arising for emergency situations anticipated

by the manufacturer.



2.2.1.3. Equipment must be so designed that part of the equipment that can

be sources of ignition is possible only under non-voltage or

via appropriate interlocking systems. If it is not possible to give

device to zero voltage, must be part of a device equipped with a pop-up

a warning label.



2.2.2. explosive environment created by air/dust mixtures



equipment must be so designed and constructed that ignition of

air/dust mixtures did not occur even in the event of frequently occurring disturbances

or equipment operating faults which normally have to be reckoned with.



2.2.2.2 For surface temperatures, requirement 2.1.2.3 applies.



2.2.2.3 for protection against dust, requirement 2.1.2.2.



2.2.2.4 For the safe opening of equipment parts, requirement point

2.2.1.3.



2.3 Requirements to equipment category 3 of equipment-group II



explosive environment created by gases, vapours or mists



2.3.1.1. Devices must be designed and constructed so that the

prevent foreseeable ignition sources which can occur during normal operation.



2.3.1.2 intended operating conditions may not surface

the temperature shall not exceed the stated maximum surface temperatures. Higher temperatures

they are admissible only in exceptional cases, provided that the

manufacturer special additional protective equipment.



2.3.2. explosive environment created by air/dust mixtures



equipment must be so designed and constructed that it cannot

result in the ignition of air/dust mixtures foreseeable ignition sources

the occurrence of which is likely to occur under normal operating conditions.



2.3.2.2 To surface temperatures, requirement 2.1.2.3 applies.



2.3.2.3. Equipment, including cable entries and connecting pieces, must be

designed to dust with regard to the size of its particles could not

inside the device to create explosive mixtures or dangerous

layers of dust.



3. Additional requirements for protective systems



3.0 General requirements



3.0.1. protective systems must be designed to reduce the effects of

explosion to a sufficient level of safety.



3.0.2. protective systems must be designed and capable of location so that

explosions can be prevented from spreading through dangerous chain reactions

or extension of the flame and suppress the transition from incipient explosions

do not become detonations.



in the event of a power failure, 3.0.3, protective systems must retain the following

long enough for their capacity to function, in order to avoid

dangerous situations.



3.0.4. protective systems must not fail due to outside interference.




3.1. Planning and design



3.1.1 properties of materials



The highest pressure and temperature, with which to be reckoned with in the planning phase of the

regard to the characteristics of the materials correspond to the anticipated explosion

pressure for extreme operating conditions and the anticipated heating

effect of the flame.



3.1.2. protective systems that are designed to withstand or

picked up the explosions must be capable of withstanding a pressure wave

without losing the integrity of the system.



3.1.3. Accessories connected to protective systems must be capable

withstanding the expected maximum explosion pressure without losing its functional

abilities.



3.1.4 in the planning and design of protective systems must be taken into

account the reactions caused by pressure in peripheral equipment and connected

pipes.



3.1.5. pressure-relief Systems



If it is likely that stresses on protective systems will exceed their

structural strength, must be in the design for suitable equipment for

release of pressure, which do not endanger persons in the vicinity.



3.1.6. Explosion suppression systems



Explosion suppression systems must be so planned and designed so as to

emergency respond to an incipient explosion at the earliest possible

stage and counteract it to best in terms of maximum speed

pressure increase and the maximum explosion pressure.



3.1.7. explosion decoupling systems



Explosion decoupling systems, which intended to disconnect as quickly as possible

device in the incipient explosions by means of appropriate devices must

be planned and designed so as to remain under operating conditions

resistant against the transmission of internal ignition and to retain their mechanical

the fortress.



3.1.8. protective systems must be capable of insertion into the circuit with a suitable

the warning threshold so that if necessary there was an interruption in the supply

and the output of the product and to the immediate cessation of those parts of the device that

can no longer function safely.



Č. 3



THE EU TYPE-EXAMINATION (MODULE B)



1. the EU type-examination is the part of a conformity assessment procedure in which

the notified body examines the technical design of a product and verifies and attests

that the technical design of the product meets the requirements of this regulation which is

the product is subject.



2. the EU type-examination shall be carried out as a sample of the complete examination

the product, which is representative of the production envisaged (serial type).



3. the manufacturer lodges an application with a single notified body of his choice,

the EU type-examination request.



The application must include:



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

his name and address,



(b)) a written declaration that the same application has not been lodged with any other

a notified body,



(c)) the technical documentation. Technical documentation shall enable

assessment of the conformity of the product with the relevant requirements of this regulation and

include an adequate analysis and assessment of risks. The technical documentation

shall specify the applicable requirements and to the extent necessary for the assessment,

cover the design, manufacture and operation of the product. The technical documentation

must contain at least the following elements:



I) a general description of the product,



II) conceptual design and manufacturing drawings and schemes of components, sub-assemblies,

circuits,



III) descriptions and explanations necessary for the understanding of the drawings,

schemes and the operation of the product,



IV) list of the harmonized standards, references to which have been published in the

The official journal of the European Union and which have been applied in full

or in part, and descriptions of the solutions adopted to meet the essential technical

the requirements of this regulation, where those harmonised standards applied

they were not, including a list of other relevant technical specifications,

that were used. In the event of partly applied harmonised standards

the technical documentation shall specify the parts which have been applied,



v) results of design calculations, examinations carried out,



vi) test reports,



(d) samples representative of the planned) production. The notified body may

request further specimens if needed for the implementation of the programme

of the tests.



4. The notified body must:



4.1. examine the technical documentation, verify that the samples were made

in conformity with the technical documentation and identify the elements which have been designed in

accordance with the applicable provisions of the relevant harmonised standards, the

as well as the elements which have been designed in accordance with other relevant

technical specifications,



4.2. perform or have performed the appropriate examinations and tests in order to

check whether, where the manufacturer has chosen the solutions in the relevant

harmonised standards, these have been applied correctly,



4.3. perform or have performed the appropriate examinations and tests in order to

determine whether, in the case where the solution has been applied according to the relevant

harmonised standards comply with the other relevant

the technical specifications used by the manufacturer, the corresponding basic

safety requirements of this regulation,



4.4 shall be agreed with the manufacturer, at which point the examinations and tests

performed.



5. the notified body shall draw up an evaluation report that records the

the activities carried out in accordance with the requirements set out in point 4 and their

the results. Without prejudice to the obligations of the notified body to the authority,

the notified body shall publish the contents of this report, in full or in

in part, only with the consent of the manufacturer.



6. Where the type meets the requirements of this regulation which shall apply to the

the product concerned, the notified body shall issue the EU type-examination certificate to the manufacturer

type. This certificate must contain the name and address of the manufacturer, conclusions of the

of the examination, conditions for its validity and the necessary data for

identification of the approved type. The EU type-examination certificate may

be accompanied by 1 or more of the annexes.



The EU type-examination certificate and its annexes shall contain all

appropriate information to allow evaluation of manufactured products in the

conformity with the examined type and perform a check in operation.



If the type does not satisfy the relevant requirements of this regulation, it rejects the

the notified body must issue a type-examination certificate of the EU and shall inform the

the applicant, with the refusal of the refusal.



7. the notified body shall ensure that it is kept informed of any changes

the generally acknowledged State of the art which indicate that the approved

type may no longer comply with the applicable requirements of this regulation, and

shall determine whether such changes require further investigation. If the investigation

require, it shall inform the notified body of the manufacturer.



The manufacturer shall inform the notified body that holds the technical

the documentation concerning the EU type-examination certificate of all

modifications to the approved type that may affect the conformity of the product with

basic technical requirements of this regulation or the conditions of

the validity of this certificate. Such modifications require additional approval

in the form of a supplement to the original EU type-examination certificate.



8. each notified body shall inform the authority of the EU type-examination certificates

type or additions thereto which it has issued or withdrawn, and shall, periodically or

on request, make available to the authority the list of these certificates or additions to

them, refused, suspended or otherwise restricted.



Each notified body shall inform the other notified bodies of the

the EU type-examination certificates and/or any additions thereto which it has refused,

withdrawn, suspended or otherwise restricted, and, upon request of the

certificates and/or any additions thereto which it has issued.



The European Commission, European Union Member States and the other notified

bodies may, on request, obtain a copy of the EU type-examination certificate

or additions thereto. The European Commission and the Member States of the European Union may

on request, obtain a copy of the technical documentation and the results of the examination

carried out by a notified body. To the expiry of the certificate

The EU type-examination, the notified body shall keep a copy of this certificate,

its annexes and additions, as well as the technical file including the

the documentation submitted by the manufacturer.



9. For a period of 10 years after placing the product on the market, the manufacturer for

the need for the supervisory authority a copy of the EU type-examination certificate, its

annexes and additions together with the technical documentation.



10. the manufacturer's authorised representative may lodge the application referred to in point 3

and to carry out the tasks set out in paragraphs 7 and 9, if they are listed in the

credentials.



Č. 4



CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

(MODULE D)



1. conformity to type based on quality assurance of the production process is

parts of a conformity assessment procedure whereby the manufacturer carries out operations

laid down in points 2 and 5, and ensures and declares that the products concerned are

in conformity with the type as described in the EU type-examination certificate and satisfy the

the requirements of this regulation which apply to them.



2. production



The manufacturer must operate an approved quality system for production, final inspection

and tests of the products specified in point 3 and shall be subject to surveillance

laid down in point 4.



3. quality system



3.1 the manufacturer lodges an application with a notified body which he has chosen, the application for

assessment of his quality system for the products concerned.



The application must include:



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

his name and address,




(b)) a written declaration that the same application has not been lodged with any other

a notified body,



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



(d)) the documentation concerning the quality system,



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

type-examination.



3.2. The quality system must ensure compliance of the products with the type as described in the

the EU type-examination certificate and with the requirements of this regulation which is

to them.



All the elements, requirements and provisions adopted by the manufacturer must be

in a systematic manner in the form of written policies, procedures and

of the instructions. The quality system documentation must permit a consistent interpretation

programmes, plans, manuals and records relating to quality.



This quality system documentation shall contain in particular an adequate description of:



and) the objectives in terms of quality and the organisational structure, responsibilities and

powers of the management with regard to product quality,



(b)) the methods, procedures and activities that are used in the manufacture, control and

quality assurance,



(c)) the examination and tests that will be carried out before, during

and after manufacture, the frequency with which,



d) quality records, such as inspection reports and records of the

tests carried out, records of calibration reports

the qualifications of the staff concerned, and



(e)) the means of monitoring the achievement of the required quality

products and the efficient operation of the quality system.



3.3 the notified body shall assess the quality system to determine whether it satisfies

the requirements laid down in point 3.2.



The elements of the quality system that comply with the relevant specifications

relevant harmonised standards, compliance with these requirements.



Persons who, on behalf of the notified body carrying out the assessment system

quality, (hereinafter referred to as "audit team") must have experience with systems

quality management and knowledge of the applicable requirements of this regulation and

at least one member with experience of evaluation in the relevant areas

products and related technologies. The audit includes an assessment visit in

the manufacturer's premises. The auditing team shall review the technical

the documentation referred to in point 3.1 (b). (e)), to make sure that the manufacturer

able to determine the requirements of this regulation and to carry out the review, to

ensuring compliance of the product with these requirements.



The conclusions of the audit, including the reasons therefor shall be notified to the manufacturer.



3.4. the manufacturer is obliged to fulfil the obligations arising from the quality system,

as approved and to maintain it so that it remains adequate and

effective.



3.5. The manufacturer shall inform the notified body that has approved the quality system,

of any intended change of the quality system.



The notified body shall evaluate the proposed changes and decide whether the modified

quality system will continue to satisfy the requirements laid down in point 3.2,

or whether a re-assessment is necessary.



The notified body shall notify the manufacturer, the conclusions of his review, including their

justification.



4. supervision of the notified body



4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations

arising out of the approved quality system.



4.2 for the purpose of assessment will allow the manufacturer to the notified body access to the

the places of manufacture, inspection, testing and storage, and shall provide the

it with all necessary information, in particular:



and quality system documentation)



(b)) the quality records, such as inspection reports and records from the

tests carried out, records of the performed calibration,

the qualifications of the personnel concerned, etc.



4.3. the notified body shall carry out periodic audits to make sure that

manufacturer maintains and applies the quality system and shall provide the manufacturer detail about

audit.



4.4. the notified body may make unannounced to the manufacturer

visits. During such visits the notified body may

If necessary, carry out or have carried out tests of products, in order to verify

whether the quality system is functioning correctly. The notified body must provide the manufacturer

with a visit report and, if tests have been carried out.



5. the CE marking, the EU Declaration of conformity and certificate of conformity



5.1 the manufacturer shall affix the CE marking and the identification number of the notified

the body, which he has chosen on each individual product that is not

part of that is in conformity with the type as described in the certificate of the EU

type-examination certificate and satisfies the requirements of this regulation.



5.2. the manufacturer shall draw up for each product model, which is not part of,

the written declaration of conformity and the EU for a period of 10 years after the product,

that is not part of, the market is a must, for the supervisory authority. IN THE EU

Declaration of conformity shall identify such product model for which it has been

drawn up.



A copy of the EU Declaration of conformity must be accompanied by a for each product,

that is not a part of.



5.3. the manufacturer shall draw up a written for each component model of the certificate of

Agreement and for a period of 10 years following the placing on the market of components is a must, for

the need for the supervisory authority.



In the certificate of conformity shall identify the model of the component for which it has been

drawn up. Copy of the certificate of conformity must accompany every

component.



6. The manufacturer shall keep at the disposal of the supervisory authority for a period of 10 years after the

product on the market:



and) documentation set out in point 3.1,



b) information about the change referred to in point 3.5, as approved,



(c)) the conclusions and reports of the notified body referred to in points

3.5, 4.3 and 4.4.



7. each notified body shall inform the Office of quality system approvals,

which it has issued or withdrawn, and shall, periodically or upon request, make available to the authority

the list of quality system approvals refused, suspended or otherwise

restricted.



Each notified body shall inform the other notified bodies of the

quality system approvals which it has refused, suspended, withdrawn or

otherwise restricted, and, upon the request of quality system approvals which it has issued.



8. Authorized Representative



The manufacturer's activities set out in points 3.1, 3.5, 5 and 6 may be

on behalf of and fulfilled by his authorised representative, if they are listed in the

credentials.



Č. 5



CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION (MODULE F)



1. conformity to type based on product verification is the part of the procedure

conformity assessment, the manufacturer performs the activities provided for in points 2

and 5 ensures and declares that the products which have been subjected to

the provisions of point 3 are in conformity with the type as described in the certificate of the EU

type-examination certificate and satisfy the requirements of this regulation, the

apply.



2. production



The manufacturer shall take steps to ensure that the manufacturing process and its monitoring ensure

compliance of the manufactured products with the approved type as described in the certificate of the EU

type-examination and with the requirements of this regulation, the

apply.



3. verification of the



The notified body, which the manufacturer has chosen, carries out an examination and

tests to verify the conformity of the products with the approved type as described in the

the EU type-examination certificate and with the requirements of this regulation.



The examinations and tests to check the conformity of the products with the requirements shall be carried out

by examination and testing of every product as laid down in point 4.



4. verification of conformity by examination and testing of every product



4.1. Each product shall be individually examined and appropriate

tests as set out in the relevant harmonised standard (harmonised

standards) or equivalent tests set out in other relevant

the technical specifications in order to verify their conformity with the approved

type as described in the EU type-examination certificate and with the relevant

the requirements of this regulation.



If there is such a harmonised standard, the notified concerned shall decide

body which tests are to be performed.



4.2. the notified body shall issue a certificate of conformity with regard to the carried out

examinations and tests and shall affix to each approved product or have it

own responsibility, affix its identification number.



The manufacturer shall keep the certificates of conformity available for inspection by

the supervisory authority for a period of 10 years after placing the product on the market.



5. the CE marking, the EU Declaration of conformity and certificate of conformity



5.1 the manufacturer shall affix the CE marking and the identification number of the notified

the body, which he has chosen on each individual product that is not

part of that is in conformity with the approved type as described in the certificate

The EU type-examination certificate and satisfies the requirements of this regulation.



5.2. the manufacturer shall draw up for each product model, which is not part of,

the written declaration of conformity and the EU for a period of 10 years after the product,

that is not part of, the market is a must, for the supervisory authority. IN THE EU

Declaration of conformity shall identify such product model for which it has been

drawn up.



A copy of the EU Declaration of conformity must be accompanied by a for each product,

that is not a part of.



If the notified body referred to in point 3 agrees, the manufacturer may

affix the other than components on the responsibility of the notified body

also affix.



5.3. the manufacturer shall draw up a written for each component model of the certificate of

Agreement and for a period of 10 years following the placing on the market of components is a must, for

the need for the supervisory authority.



In the certificate of conformity shall identify the model of the component for which it has been

drawn up. Copy of the certificate of conformity must accompany every

component.




6. If the notified body agrees, the manufacturer may affix the

the notified body's identification number during the manufacturing process.



7. Authorized Representative



Activities on behalf of the manufacturer may be fulfilled by his authorised

Representative, if they are specified in the mandate. Authorized representative cannot

carry out the activities provided for in point 2 of the manufacturer.



Č. 6



CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS PRODUCT TESTING UNDER

SUPERVISION (Module C1)



1. conformity to type based on internal production control plus product testing by a

under the supervision of is part of a conformity assessment procedure whereby the manufacturer performs

the activities provided for in paragraphs 2, 3 and 4, and ensures and declares that the

the products are in conformity with the type as described in the EU type-examination certificate

type and meet the requirements of this regulation which apply to them.



2. production



The manufacturer shall take steps to ensure that the manufacturing process and its monitoring ensure

compliance of the manufactured products with the type as described in the EU type-examination certificate

the type and the requirements of this regulation which apply to them.



3. Controls of products



For each individual product manufactured by the manufacturer or on his behalf is

one or more of the tests of 1 or more specific properties

the product, in order to verify conformity with the type as described in the certificate of the EU

type-examination and with the requirements of this regulation. The test shall be carried out on

the responsibility of a notified body chosen by the manufacturer.



The manufacturer must affix the identification number of the notified body no longer

during the manufacturing process.



4. the CE marking, the EU Declaration of conformity and certificate of conformity



4.1. The manufacturer shall affix the CE marking to each individual product that is not

part of that is in conformity with the type as described in the certificate of the EU

type-examination certificate and satisfies the requirements of this regulation.



4.2. the manufacturer shall draw up a written EU Declaration of conformity for a product model

that is not a part of, and for a period of 10 years after the product is

components on the market is a must, for the supervisory authority. The EU Declaration

of conformity must be given such a model of the product, for which it has been

drawn up.



A copy of the EU Declaration of conformity must be accompanied by a for each product,

that is not a part of.



4.3. the manufacturer shall draw up a written for each component model of the certificate of

Agreement and for a period of 10 years following the placing on the market of components is a must, for

the need for the supervisory authority.



In the certificate of conformity shall identify the model of the component for which it has been

drawn up. Copy of the certificate of conformity must accompany every

component.



5. Authorized Representative



The activities of the manufacturer referred to in point 4 may be fulfilled, on his behalf and

his authorised representative, if they are specified in the mandate.



Č. 7



CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE (MODULE E)



1. conformity to type based on quality assurance of the products is part of the

conformity assessment procedure whereby the manufacturer carries out the activities provided for in the

points 2 and 5, and ensures and declares that the products concerned are in conformity with the

type as described in the EU type-examination certificate and satisfy the requirements of

This regulation, which applies to them.



2. production



The manufacturer must operate an approved quality system for final inspection and

tests of the products specified in point 3 and shall be subject to the supervision provided for

in point 4.



3. quality system



3.1 the manufacturer lodges an application with a notified body which he has chosen, the application for

assessment of his quality system for the products concerned.



The application must include:



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

his name and address,



(b)) a written declaration that the same application has not been lodged with any other

a notified body,



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



(d)) the documentation concerning the quality system,



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

type-examination.



3.2. The quality system must ensure compliance of the products with the type as described in the

the EU type-examination certificate and with the appropriate requirements of this

of the regulation.



All the elements, requirements and provisions adopted by the manufacturer must be

in a systematic manner in the form of written policies, procedures and

of the instructions. The quality system documentation must permit a consistent interpretation

programmes, plans, manuals and records relating to quality.



This quality system documentation shall contain in particular an adequate description of:



and) the objectives in terms of quality and the organisational structure, responsibilities and

powers of the management with regard to product quality,



(b)) the examination and tests that will be carried out after manufacture,



(c)) the quality records, such as inspection reports and records of the

tests carried out, records of calibration reports

the qualifications of the personnel concerned,



(d)) the means of monitoring the efficient operation of the system

the quality.



3.3 the notified body shall assess the quality system to determine whether it satisfies

the requirements laid down in point 3.2.



The elements of the quality system that comply with the relevant specifications

relevant harmonised standards, compliance with these requirements.



The auditing team must have experience in quality management systems and knowledge

the relevant requirements of this regulation and at least one Member must have

experience of evaluation in the relevant product field and the appropriate

technology. The audit includes an assessment visit to the premises of the

manufacturer. The auditing team shall review the technical documentation provided for in

section 3.1 (b). (e)), to verify the manufacturer's ability to identify the requirements of the

of this regulation and to carry out a review to ensure compliance of the product with the

those requirements.



The conclusions of the audit, including the reasons therefor shall be notified to the manufacturer.



3.4. the manufacturer is obliged to fulfil the obligations arising from the quality system,

as approved and to maintain it so that it remains adequate and

effective.



3.5. The manufacturer shall inform the notified body that has approved the quality system,

of any intended change of the quality system.



The notified body shall evaluate the proposed changes and decide whether the modified

quality system will continue to satisfy the requirements laid down in point 3.2,

or whether a re-assessment is necessary.



The notified body shall notify the manufacturer, the conclusions of his review, including their

justification.



4. supervision of the notified body



4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations

arising out of the approved quality system.



4.2 for the purpose of assessment will allow the manufacturer to the notified body access to the

the places of manufacture, inspection, testing and storage, and shall provide the

it with all necessary information, in particular:



and quality system documentation)



(b)) the quality records, such as inspection reports and records from the

tests carried out, records of the performed calibration,

the qualifications of the personnel concerned, etc.



4.3. the notified body shall carry out periodic audits to make sure that

manufacturer maintains and applies the quality system and shall provide the manufacturer detail about

audit.



4.4. the notified body may make unannounced to the manufacturer

visits. During such visits the notified body may

If necessary, carry out or have carried out tests of products, in order to verify

whether the quality system is functioning correctly. The notified body must provide the manufacturer

with a visit report and, if tests have been carried out.



5. the CE marking, the EU Declaration of conformity and certificate of conformity



5.1 the manufacturer shall affix the required CE marking laid down in section 13 and

the identification number of the notified body, which chose, on each

the individual product, which is not part of and which is in conformity with the type

as described in the EU type-examination certificate and satisfies the requirements of this

of the regulation.



5.2. the manufacturer shall draw up for each product model, which is not part of,

the written declaration of conformity and the EU for a period of 10 years after the product,

that is not part of, the market is a must, for the supervisory authority. IN THE EU

Declaration of conformity shall identify such product model for which it has been

drawn up.



A copy of the EU Declaration of conformity must be accompanied by a for each product,

that is not a part of.



5.3. the manufacturer shall draw up a written for each component model of the certificate of

Agreement and for a period of 10 years following the placing on the market of components is a must, for

the need for the supervisory authority.



In the certificate of conformity shall identify the model of the component for which it has been

drawn up. Copy of the certificate of conformity must accompany every

component.



6. The manufacturer shall keep at the disposal of the supervisory authority for a period of 10 years after the

product on the market:



and) documentation set out in point 3.1,



b) information about the change referred to in point 3.5, as approved,



(c)) the conclusions and reports of the notified body referred to in points

3.5, 4.3 and 4.4.



7. each notified body shall inform the Office of quality system approvals,

which it has issued or withdrawn, and shall, periodically or upon request, make available to the authority

the list of quality system approvals refused, suspended or otherwise

restricted.



Each notified body shall inform the other notified bodies of the

quality system approvals which it has refused, suspended or withdrawn, and

at the request of quality system approvals which it has issued.



8. Authorized Representative



The manufacturer's activities set out in points 3.1, 3.5, 5 and 6 may be


on behalf of and fulfilled by his authorised representative, if they are listed in the

credentials.



Č. 8



THE INTERNAL PRODUCTION CONTROL (MODULE A)



1. Internal production control is the conformity assessment procedure whereby the manufacturer

performs the activities provided for in paragraphs 2, 3 and 4, and ensures and declares

that the products concerned satisfy the requirements of this regulation, the

apply.



2. Technical documentation



The manufacturer shall establish the technical documentation. The technical documentation must

enable the conformity of the product with the requirements of this regulation and

include an adequate analysis and assessment of risks.



Technical documentation shall specify the requirements of this regulation and, to the extent

necessary for the assessment must cover the design, manufacture and operation of the

of the product. The technical documentation shall contain at least the following elements:



and a general description of the product)



b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies,

circuits,



c) descriptions and explanations necessary for the understanding of those drawings and schemes

and operation of the product,



(d)) the list of harmonized standards, references to which have been published in the

The official journal of the European Union and which have been applied in full

or in part, and descriptions of the solutions adopted to meet the essential technical

the requirements of this regulation, where those harmonised standards applied

they were not, including a list of other relevant technical specifications,

that were used. In the event of partly applied harmonised standards

the technical documentation shall specify the parts which have been applied,



e) results of design calculations, examinations carried out,



f) test reports.



3. production



The manufacturer shall take steps to ensure that the manufacturing process and its monitoring ensure

compliance of the manufactured products with the technical documentation referred to in point 2 and

with the requirements of this regulation which apply to them.



4. the CE marking, the EU Declaration of conformity and certificate of conformity



4.1. The manufacturer shall affix the CE marking to each individual product that is not

component that satisfies the requirements of this regulation.



4.2. the manufacturer shall draw up a written EU Declaration of conformity for a product model

that is not a part of, and for a period of 10 years after the product is

components on the market, together with the technical documentation for

the need for the supervisory authority. The EU Declaration of conformity shall identify such

the product model for which it has been drawn up.



A copy of the EU Declaration of conformity must be accompanied by a for each product,

that is not a part of.



4.3. the manufacturer shall draw up a written for each component model of the certificate of

conformity and for a period of 10 years after the component on the market

the technical documentation at the disposal of the supervisory authority. In the certificate

on the conformity of the component must be included for which it has been drawn up. A copy of the

the certificate of conformity must be attached to each component.



5. Authorized Representative



The activities of the manufacturer referred to in point 4 may be fulfilled, on his behalf and

his authorised representative, if they are specified in the mandate.



Č. 9



CONFORMITY TO TYPE BASED ON UNIT VERIFICATION (MODULE

(G))



1. conformity based on unit verification is the procedure

conformity assessment, which the manufacturer shall conduct the activities provided for in paragraphs 2,

3 and 5, and ensures and declares that the product has been subjected to

the provisions of point 4, is in conformity with the requirements of this regulation which is

applicable to it.



2. Technical documentation



2.1. The manufacturer shall establish the technical documentation and make it available to

the notified body, which he has chosen. The technical documentation must

enable the conformity of the product with the requirements of this regulation and

include an adequate analysis and assessment of risks. The technical documentation

must specify the requirements of this regulation and to the extent necessary for the assessment,

must cover the design, manufacture and operation of the product. Technical

the documentation shall contain at least the following elements:



and a general description of the product)



b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies,

circuits,



c) descriptions and explanations necessary for the understanding of those drawings and schemes

and operation of the product,



(d)) the list of harmonized standards, references to which have been published in the

The official journal of the European Union and which have been applied in full

or in part, and descriptions of the solutions adopted to meet the essential technical

the requirements of this regulation, where those harmonised standards applied

they were not, including a list of other relevant technical specifications,

that were used. In the event of partly applied harmonised standards

the technical documentation shall specify the parts which have been applied,



e) results of design calculations, examinations carried out,



f) test reports.



2.2. the manufacturer shall keep the technical documentation at the disposal of the competent

the supervisory authority for a period of 10 years after placing the product on the market.



3. production



The manufacturer shall take all measures necessary so that the manufacturing process and its

monitoring ensure conformity of the manufactured product with the requirements of this

of the regulation.



4. verification of the



A notified body chosen by the manufacturer, shall carry out or have carried out

examinations and tests set out in the relevant harmonised standards

or equivalent tests set out in other relevant technical

specifications, to check the conformity of the product with the requirements of this regulation.

If there is such a harmonised standard, the notified concerned shall decide

body which tests are to be performed.



The notified body shall issue a certificate of conformity with regard to the carried out

examinations and tests and shall affix on the approved product, or have it custom

responsibility to affix its identification number.



The manufacturer shall keep the certificates of conformity at the disposal of the supervisory authority for 10

years after placing the product on the market.



5. the CE marking, the EU Declaration of conformity and certificate of conformity



5.1 the manufacturer shall affix the CE marking and the identification number of the notified

the body, which he has chosen on each product that is not part of and

that meets the requirements of this regulation.



5.2. the manufacturer shall draw up a written declaration of conformity and the EU for a period of 10 years from the

the product, which is not part of, the market is a must, for

the supervisory authority. The EU Declaration of conformity shall identify such product,

for which it has been drawn up.



A copy of the EU Declaration of conformity must be accompanied by a for each product,

that is not a part of.



5.3. the manufacturer shall draw up a written certificate of conformity for a period of 10 years from

the placing on the market of components is a must, for the supervisory authority. In

the certificate of conformity must be given part of the country for which it was drawn up.

Copy of the certificate of conformity shall be attached to each component.



6. Authorized Representative



The manufacturer's activities set out in points 2.2 and 5 may be his name

fulfilled by his authorised representative, if they are specified in the mandate.



Č. 10



EU Declaration of conformity (# XXXX) ^ 3)

1. Product Model/product (product number, type, batch or serial number):



2. the name and address of the manufacturer and of his authorised representative, if any:



3. this Declaration of conformity is issued under the sole responsibility of the manufacturer.



4. Object of the Declaration (identification of product allowing traceability it;

If it is necessary for the identification of the product, may include

shown):



5. object of the Declaration described above is in conformity with the relevant Community harmonisation

regulations of the European Union:



6. references to the relevant harmonised standards which have been applied, or to other

technical specifications by reference to which conformity is declared:



7. If necessary, the notified body must: ... (name, number) performed ... (description of intervention) and

issued the certificate:



8. other information:



Signed for and on behalf of ...:

(place and date of issue):

(name, function) (signature):



1) directive of the European Parliament and of the Council/34/EU of 26 March. February

2014 on the harmonisation of the laws of the Member States relating to the

equipment and protective systems intended for use in an environment with

danger of explosion.



2) Government Regulation No. 21/2003 Coll. laying down technical requirements

on personal protective equipment.



European Parliament and Council Regulation (EU) no 2016/425 laying

shall lay down harmonised conditions for the marketing of personal protective

devices on the market.



3) the manufacturer may give the number of the Declaration of conformity.

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