Source: https://www.global-regulation.com/translation/czech-republic/3461732/conformity-assessment-of-equipment-in-potentially-explosive-atmospheres.html
Timestamp: 2020-07-10 22:39:10
Document Index: 481958330

Matched Legal Cases: ['§ 4', '§ 50', '§ 10', '§ 5', '§ 5', '§ 7', '§ 1', '§\n13', '§ 5', '§ 7', '§ 1']

Machine Translation of "Conformity Assessment Of Equipment In Potentially Explosive Atmospheres" (Czech Republic)
Conformity Assessment Of Equipment In Potentially Explosive Atmospheres
Original Language Title: posuzování shody zařízení v prostředí s nebezpečím výbuchu
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) 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.
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
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.
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
(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.
(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.
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.
(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
(4) the importer shall indicate on the product in a language comprehensible to the final users
mark, and the address for service.
(5) the importer performs in order to protect the health and safety of the final
by the manufacturer, its intended purpose of use. The importer keeps records of complaints,
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
(c) manufacturers and importers meet) the requirements set out in § 5 para. 4 and 5, and in the
§ 7 para. 4.
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.
(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
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
(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.
(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
(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
(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
Affixing the CE marking, identification number of notified bodies and
(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
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,
(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.
(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.
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.
This Regulation shall enter into force on 20 March 2004. April 2016.
Ing. Mládek, CSc., r.
CRITERIA FOR THE CLASSIFICATION OF THE DEVICE GROUPS INTO CATEGORIES
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
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
by the manufacturer and ensuring a high level of protection.
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 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
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
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
point 2.1 of the annex 2 to this regulation.
(b) Category 2 comprises equipment) devices that are designed to
It is likely the occasional formation of an explosive atmosphere of gas,
vapours, mists, or air/dust mixtures.
the required level of protection in the event of frequently occurring disturbances or
the failure of the unit, which should be normally count on.
section 2.2 of annex 2 to this regulation.
c) device category 3 comprises equipment designed to
by the manufacturer and ensuring a normal level of protection.
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
section 2.3 of annex 2 to this regulation.
THE BASIC REQUIREMENTS FOR HEALTH AND SAFETY RELATING TO THE DESIGN AND
CONSTRUCTION OF EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN AN ENVIRONMENT
A. you need to take into account the technological knowledge, and shall
(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.
comprehensive safety principles in terms of explosion
explosion must be designed with regard to the safety of the
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
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
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
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
c) Literature describing the equipment or protective system must not, if
refers to safety aspects, in violation of the instructions.
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
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.
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.
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
Equipment and protective systems which may be exposed to certain types of
of external stresses must be fitted with additional, if needed
The equipment must withstand relevant stresses without any negative impact on the
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.
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
d) assure that foreseeable conditions of overload shall not arise
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
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
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.
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.
It should be the appropriate means to prevent electrostatic charges
capable of resulting in dangerous discharges.
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.
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.
1.4.1. 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
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.
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
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.
1.6.1. 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
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.
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.
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
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
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
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
Where necessary, equipment must be provided with the appropriate additional
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
2.0.2.2. Equipment must be so designed that part of the equipment that can
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
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
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
2.1.1.3. Equipment must be so designed that part of the equipment that can
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
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
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
2.2 requirements for category 2 of equipment-group II
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
2.2.1.3. Equipment must be so designed that part of the equipment that can
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
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
2.3 Requirements to equipment category 3 of equipment-group II
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
3. Additional requirements for protective systems
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
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
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
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.
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.
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
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.
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.
and the name and address of the manufacturer), and if the application is lodged by the authorised representative,
(b)) a written declaration that the same application has not been lodged with any other
(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,
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
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
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
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
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.
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.
3.1 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.
(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
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
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
(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
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
4. supervision of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations
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
and quality system documentation)
(b)) the quality records, such as inspection reports and records from the
tests carried out, records of the performed calibration,
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
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
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
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
quality system approvals which it has refused, suspended, withdrawn or
otherwise restricted, and, upon the request of quality system approvals which it has issued.
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
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
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
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.
4.1. 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.
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.
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.
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.
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.
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
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
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
4.3. the manufacturer shall draw up a written for each component model of the certificate of
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.
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.
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
the EU type-examination certificate and with the appropriate requirements of this
(b)) the examination and tests that will be carried out after manufacture,
(c)) the quality records, such as inspection reports and records of the
the qualifications of the personnel concerned,
(d)) the means of monitoring the efficient operation of the system
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
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
quality system approvals which it has refused, suspended or withdrawn, and
at the request of quality system approvals which it has issued.
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
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,
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
e) results of design calculations, examinations carried out,
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.
component that satisfies the requirements of this regulation.
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.
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.
CONFORMITY TO TYPE BASED ON UNIT VERIFICATION (MODULE
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
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
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:
2.2. the manufacturer shall keep the technical documentation at the disposal of the competent
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
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.
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.
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.
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.
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.
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:
4. Object of the Declaration (identification of product allowing traceability it;
If it is necessary for the identification of the product, may include
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:
Signed for and on behalf of ...:
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
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
3) the manufacturer may give the number of the Declaration of conformity.
2016 Equipment Used In Potentially Explosive Atmospheres And Protection Rules
2016 On Conformity Assessment Of Radio Equipment On The Market When Supply
2016 Royal Decree 144/2016 Of 8 April, The Essential Health And Payable To Equipment And Protective Systems Intended For Use In Potentially Explosive Atmospheres And Amending The Royal Decree Establishing Security ...
1994 Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres
2016 Conformity Assessment Of Simple Pressure Vessels
1997 Regulations On Equipment And Safety Systems For Use In Hazardous Areas
2016 Of The Ship's Rigging
2013 Ordinance On Interior Design, Etc. Of Equipment And Protective Systems Intended For Use In Explosive Atmospheres On Fixed Offshore Structures