Conformity Assessment Procedure for Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres (ATEX)

CONFORMITY ASSESSMENT - ofEquipment and protective systems intended for use in potentially explosive atmospheres as of April 20, 2016

Equipment and protective systems intended for use in potentially explosive atmospheres are specified products defined by Act No. 90/2016 Coll. on the conformity assessment of specified products when placed on the market and fall within the harmonized scope. On April 20, 2016, Directive 2014/34/EU of the European Parliament and of the Council on the harmonization of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres entered into force, repealing and replacing Directive 94/9/EC of the European Parliament and of the Council. This new directive is implemented in the Czech Republic through the new Government Regulation No. 116/2016 Coll. , which repeals, as of April 20, 2016, Government Regulation No. 23/2003 Coll., under which conformity assessment had previously been conducted.

SCOPE OF
APPLICATION Government Regulation No. 116/2016 Coll. applies to equipment and protective systems intended for use in potentially explosive atmospheres, as well as to safety, control, and regulating devices intended for use outside potentially explosive atmospheres, but are necessary for the safe operation of products and protective systems or contribute to the safe operation of products. Government Regulation No. 116/2016 Coll. does not apply to medical devices used in a medical environment; to equipment for domestic use and environments where an explosion may occur as a result of an accidental leak of heating gas; equipment and protective systems where the explosion hazard results from the presence of explosives or chemically unstable substances; certain means of transport specified in this Government Regulation; personal protective equipment; seagoing vessels and mobile offshore units; equipment for the manufacture of weapons, ammunition, and military equipment.

SOME DEFINITIONS

Government Regulation No. 116/2016 Coll. defines equipment as “machines, devices, fixed or mobile installations, control components and their instrumentation, and detection or preventive protection systems that are individually or collectively intended for the production, transmission, accumulation, measurement, regulation, and conversion of energy or the processing of materials, and which are capable of causing an explosion due to their own potential ignition sources.”

Government Regulation No. 116/2016 Coll. defines protective systems as “devices other than equipment components that are intended to immediately suppress the initial stage of an explosion or to limit the extent of the effects of an explosion and that are placed on the market separately and used as independent systems.”

Components are elements that are essential for the safe operation of equipment and protective systems but do not have an independent function.

An explosive atmosphere is an environment in which mixtures of flammable substances in the form of gases, vapors, mists, or dusts are present, which under certain operating conditions may ignite with air under atmospheric conditions.

TECHNICAL REQUIREMENTS FOR EQUIPMENT AND PROTECTIVE
SYSTEMSAnnex No. 2 to Government Regulation No. 116/2016 Coll. contains the essential health and safety requirements concerning the design and construction of equipment and protective systems intended for use in potentially explosive atmospheres.

PLACING ON THE MARKET AND PUTTING INTO
SERVICEProducts may be placed on the market or put into service only if they meet the requirements set forth in Section 4(1) of Government Regulation No. 116/2016 Coll. Products that do not comply with Government Regulation No. 116/2016 Coll. may be displayed at trade fairs and exhibitions provided that such non-compliance is clearly indicated. These products may be placed on the market or put into service only if the manufacturer brings them into compliance with Government Regulation No. 116/2016 Coll.

MANUFACTURER’S OBLIGATIONS

may not transfer their obligations regarding the design, manufacture of the product, and preparation of technical documentation to an authorized representative;
must ensure that the product is designed and manufactured in accordance with the essential technical requirements set forth in Annex 2 of Government Regulation No. 116/2016 Coll.;
must prepare the technical documentation specified in Annexes 3 through 9 of Government Regulation No. 116/2016 Coll.;
must carry out or have carried out the conformity assessment procedure in accordance with Section 10 of Government Regulation No. 116/2016 Coll.;
after demonstrating compliance with the essential requirements through the conformity assessment procedure, the manufacturer must draw up an EU declaration of conformity and affix the CE marking to the product that is not a component;
after demonstrating compliance with the essential requirements through the conformity assessment procedure, the manufacturer must draw up a written certificate of conformity for the component in accordance with Section 10(3) of Government Regulation No. 116/2016 Coll.;
The manufacturer must retain the technical documentation for a period of 10 years from the date the product was placed on the market;
must ensure compliance with the traceability requirements for products that the manufacturer has placed on the market and that are not components; must ensure special explosion protection marking and, where applicable, other markings and information specified in Section 1.0.5 of Annex No. 2 to Government Regulation No. 116/2016 Coll.;
for end users and supervisory authorities, must clearly indicate their identification details on the product, on its packaging, or in a document accompanying the product;
must ensure that a copy of the EU Declaration of Conformity or Certificate of Conformity is attached to each product (in the case of a single shipment of a larger quantity of products, the shipment may be accompanied by a single copy of the EU Declaration of Conformity or Certificate of Conformity);
is required to conduct, for the purpose of protecting the health and safety of end users, tests on samples of products placed on the market and other necessary investigations in light of the risks posed by such products;
must keep records of complaints, non-compliant products, and product recalls, and inform the distributors to whom these products were supplied of these facts;
inform the distributors to whom these products were supplied of these facts.

OBLIGATIONS OF THE AUTHORIZED REPRESENTATIVE
must perform the tasks specified in the mandate received from the manufacturer, including at a minimum:

retain the technical documentation, EU Declaration of Conformity, or Certificate of Conformity for supervisory authorities for a period of 10 years from the date the product was placed on the market

OBLIGATIONS OF THE IMPORTER

must ensure that the manufacturer properly fulfills its obligations regarding the conformity assessment procedure, the preparation of technical documentation, CE marking, the EU Declaration of Conformity, or the Certificate of Conformity;
must ensure that the manufacturer has met the product traceability requirements;
must verify the manufacturer’s compliance with requirements for end users and supervisory authorities—clear indication of the manufacturer’s identification details on the product, its packaging, or in a document accompanying the product;
must ensure that instructions and safety information in the Czech language are included with the product;
must retain a copy of the EU Declaration of Conformity or Certificate of Conformity for the needs of supervisory authorities for a period of 10 years from the date the product was placed on the market;
must ensure that technical documentation is submitted upon request by supervisory authorities;
must clearly indicate their identification details on the product, its packaging, or in a document accompanying the product for end users and supervisory authorities;
is required to conduct, for the purpose of protecting the health and safety of end users, tests on samples of products placed on the market and other necessary investigations in light of the risks posed by the product;
must keep records of complaints, non-compliant products, and product recalls, and inform the distributors to whom these products were supplied of such facts.

OBLIGATIONS OF
DISTRIBUTORS: must verify, prior to placing the product on the market, whether

the product bears the CE marking;
must verify, prior to placing the product on the market, whether the product is accompanied by an EU Declaration of Conformity or a Certificate of Conformity;
the required documents, instructions, and safety information are provided with the product in the Czech language;
the manufacturer has indicated on the product their name, registered trade name, or registered trademark and address (the single point of contact for the manufacturer); if the nature or size of the product does not allow for the indication of this information, the required information must be indicated on the packaging or in a document accompanying the product;
the importer has indicated on the product their name, registered trade name, or registered trademark and the address at which they can be contacted; if the nature or size of the product does not allow for the inclusion of this information, the required information must be provided on the packaging or in a document accompanying the product;
the manufacturer has complied with the product traceability requirements.

PRODUCT TRACEABILITY, IDENTIFICATION OF THE ECONOMIC OPERATOR Act
No. 90/2016 Coll. on the conformity assessment of specified products sets out the requirements for product traceability in more detail, but does not specify how this requirement is to be implemented. The manufacturer must ensure product traceability; products placed on the market must bear a type or batch number, serial number, or other element enabling their identification. In cases where the size or nature of the product does not allow this, the required information must be provided on the packaging or in a document accompanying the product. Traceability enables supervisory authorities to trace the history of the product. The manufacturer and importer (or distributor) are responsible for meeting traceability requirements; they must retain data for a period of 10 years from the date the product was placed on the market, using which the economic operator who supplied the product to them or to whom they supplied the product can be identified.

DEVICE GROUPS AND DEVICE
CATEGORIESAnnex No. 1 to Government Regulation No. 116/2016 Coll. contains criteria for classifying device groups into categories. An equipment category is a classification of equipment within each equipment group specified in Annex No. 1 to Government Regulation No. 116/2016 Coll. and defining the required level of protection that must be guaranteed. Annex No. 1 to Government Regulation No. 116/2016 Coll. specifies two groups of equipment designated as: Equipment Group I and Equipment Group II. These two groups of equipment are further divided into individual categories.

Equipment
Group Iis intended for use in underground sections of mines and in those parts of the surface installations of these mines that are at risk from mine gas or combustible dust
. Category
M1 of Equipment Group Ihas a very high level of protection; it must remain functional even in the event of emergencies and must ensure the required level of safety even in the event of two mutually independent failures (two independent structural protective measures).
Category M2 has a high level of protection; in the event of an explosive atmosphere, it must be disconnected from the power supply and must ensure the required level of safety during both normal and adverse operating conditions.

Equipment Group
IIEquipment Group II
CategoriesCategory 1 EquipmentCategory
1 equipment has a very high level of protection; it must remain functional even in the event of emergencies and must ensure the required level of safety even in the event of two mutually independent failures (two independent design protection measures). Category 1 equipment is intended for use in areas where an explosive atmosphere created by gases, vapors, mists, or dust-air mixtures is present continuously, for long periods, or frequently.
Category 2
equipment Category 2 equipment has a high level of protection; it must remain functional even in the event of frequently occurring faults or normal equipment failure. Category 2 equipment is intended for use in areas where an explosive atmosphere created by gases, vapors, mists, or dust-air mixtures is likely to occur occasionally.
Category 3 equipment Category
3 equipment has a standard level of protection and must ensure the required level of safety during normal operation. Category 3 equipment is intended for use in areas where the formation of an explosive atmosphere caused by gases, vapors, mists, or dust-air mixtures is not likely, and if an explosive atmosphere does form, it is likely to occur only rarely and for a short period of time.

CONFORMITY ASSESSMENT PROCEDURES

Conformity assessment demonstrates compliance with the essential requirements. Documents and correspondence relating to conformity assessment procedures shall be drawn up in the Czech language. The following procedures shall be used for conformity assessment for these groups of equipment:

Equipment Group I, Equipment Category M 1, Equipment Group II, Equipment Category 1

Module	Module Type	Manufacturer	OS	Manufacturer's laboratory	Type Test	System audit
MODULE B	EU TYPE TESTING	NO	YES	NO	YES	NO
MODULE D	CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE MANUFACTURING PROCESS	NO	YES	NO	NO	YES
MODULE F	CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION	NO	YES	NO	YES	NO

Equipment Group I, Equipment Category M 2, Equipment Group II, Equipment Category 2 – internal combustion engines and electrical equipment

Module	Module type	Manufacturer	OS	Manufacturer’s laboratory	Type Test	System audit
MODULE B	EU TYPE TESTING	NO	YES	NO	YES	NO
MODULE C1	Conformity to type based on internal production control plus supervised product testing	YES	YES/NO	YES/NO	YES	NO
MODULE E	CONFORMITY TO TYPE BASED ON METER QUALITY ASSURANCE	NO	YES	NO	NO	YES

Equipment Group I, Equipment Category M 2, Equipment Group II, Equipment Category 2 – other equipment

Module	Module type	Manufacturer	OS	Manufacturer’s laboratory	Type Test	System audit
MODULE A	INTERNAL PRODUCTION CONTROL	YES	NO	NO	NO	NO

Device Group II, Device Category 3

Module	Module type	Manufacturer	OS	Manufacturer's laboratory	Type Test	System audit
MODULE A	INTERNAL PRODUCTION CONTROL	YES	NO	NO	NO	NO

Equipment Group I, Equipment Group II

Module	Module type	Manufacturer	OS	Manufacturer's laboratory	Type Test	System audit
MODULE B	EU TYPE TESTING	NO	YES	NO	YES	NO
MODULE D	CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE MANUFACTURING PROCESS	NO	YES	NO	NO	YES
MODULE F	CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION	NO	YES	NO	YES	NO
MODULE G	CONFORMITY BASED ON VERIFICATION OF EACH INDIVIDUAL PRODUCT	NO	YES	NO	YES	NO
MODULE C1	Conformity to type based on internal production control plus supervised product testing	YES	YES/NO	YES/NO	YES	NO
MODULE E	CONFORMITY TO TYPE BASED ON METER QUALITY ASSURANCE	NO	YES	NO	NO	YES
MODULE A	INTERNAL PRODUCTION MANAGEMENT	YES	NO	NO	NO	NO

Protection systems

Module	Module type	Manufacturer	OS	Manufacturer's laboratory	Type Test	System audit
MODULE B	EU TYPE TESTING	NO	YES	NO	YES	NO
MODULE D	CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE MANUFACTURING PROCESS	NO	YES	NO	NO	YES
MODULE F	CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION	NO	YES	NO	YES	NO
MODULE G	CONFORMITY BASED ON VERIFICATION OF EACH INDIVIDUAL PRODUCT	NO	YES	NO	YES	NO
MODULE C1	Conformity to type based on internal production control plus supervised product testing	YES	YES/NO	YES/NO	YES	NO
MODULE E	CONFORMITY TO TYPE BASED ON THE QUALITY ASSURANCE SYSTEM OF THE METER	NO	YES	NO	NO	YES
MODULE A	INTERNAL PRODUCTION MANAGEMENT	YES	NO	NO	NO	NO

Components

Module	Module type	Manufacturer	OS	Manufacturer's laboratory	Type Test	System audit
MODULE B	EU TYPE TESTING	NO	YES	NO	YES	NO
MODULE D	CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE MANUFACTURING PROCESS	NO	YES	NO	NO	YES
MODULE F	CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION	NO	YES	NO	YES	NO
Module C1	CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING	YES	YES/NO	YES/NO	YES	NO
MODULE E	CONFORMITY TO TYPE BASED ON THE QUALITY ASSURANCE OF THE METER	NO	YES	NO	NO	YES
MODULE A	INTERNAL PRODUCTION MANAGEMENT	YES	NO	NO	NO	NO

Protection against other hazards (Section 1.2.7 of Annex No. 2 to Government Regulation No. 116/2016 Coll.)

Module	Module type	Manufacturer	OS	Manufacturer’s laboratory	Type Test	System audit
MODULE B	EU TYPE TESTING	NO	YES	NO	YES	NO
MODULE D	CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE MANUFACTURING PROCESS	NO	YES	NO	NO	YES
MODULE F	CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION	NO	YES	NO	YES	NO
MODULE C1	Conformity to type based on internal production control plus supervised product testing	YES	YES/NO	YES/NO	YES	NO
MODULE E	CONFORMITY TO TYPE BASED ON METER QUALITY ASSURANCE	NO	YES	NO	NO	YES
MODULE A	INTERNAL PRODUCTION MANAGEMENT	YES	NO	NO	NO	NO
MODULE F	CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION	NO	YES	NO	YES	NO
MODULE G	CONFORMITY BASED ON VERIFICATION OF EACH INDIVIDUAL PRODUCT	NO	YES	NO	YES	NO

PRESUMPTION OF
CONFORMITY The essential technical requirements are deemed to be met if the product complies with the safety requirements of harmonized Czech technical standards or, where applicable, foreign technical standards that transpose a harmonized European standard in EU Member States. Where no harmonized European technical standards exist, the ÚNMZ shall publish in the ÚNMZ Bulletin information on existing Czech technical standards or other documents containing technical specifications deemed suitable for the proper implementation of the technical requirements for the product.

EU DECLARATION OF CONFORMITY

The EU Declaration of Conformity is a confirmation of compliance with all essential technical requirements. A model EU Declaration of Conformity is provided in Annex No. 10 to Government Regulation No. 116/2016 Coll. and must be kept up to date. The EU Declaration of Conformity is translated into the language or languages required by the EU Member State in which the product is placed or supplied on the market. If a product is subject to multiple European Union harmonization regulations requiring the preparation of an EU Declaration of Conformity, a single EU Declaration of Conformity is prepared with references to all such regulations, including references to their publication. This single EU Declaration of Conformity may take the form of a dossier consisting of declarations of conformity issued for individual regulations.

PLACEMENT OF THE CE MARKING, IDENTIFICATION NUMBERS OF NOTIFIED BODIES, AND OTHER
MARKINGS Before placing the product on the market, the CE marking shall be affixed to the product or its label; if the nature of the product does not allow this, the CE marking shall be affixed to the packaging and the accompanying documents. The manufacturer or its authorized representative shall affix, after the CE marking, the identification number of the notified body (NB) that participated in the conformity assessment of the product in accordance with the relevant annexes specified in Government Regulation No. 116/2016 Coll. The CE marking and/or the identification number of the notified body shall be followed by a specific explosion protection marking (see figure), the group and category marks of the equipment, and, where applicable, other markings and information specified in Section 1.0.5 of Annex No. 2 to Government Regulation No. 116/2016 Coll. The CE marking and other markings may also be followed by another mark indicating a specific risk or use. Products designed for specific explosive atmospheres must be marked accordingly.

MARKING IN ACCORDANCE WITH SECTION 1.0.5 OF ANNEX 2 At least the following information must be marked on
equipment and protective systems in a legible and indelible manner:
a) the name, trade name, or trademark and address of the manufacturer,
b) the CE marking (see Annex II to Regulation (EC) No. 765/2008),
c) the series or type designation,
d) the batch number or serial number, if any,
e) year of manufacture,
f) specific explosion protection marking (see figure below) followed by the group and category marking of the equipment,

g) for equipment group II, the letter "G" (for explosive atmospheres caused by gases, vapors, or mists mixed with air), orh
) the letter "D" (for explosive atmospheres caused by dust-air mixtures).
In addition, equipment and protective systems must be marked, where necessary, with all information relevant to the safe use of the equipment and protective systems.

TECHNICAL DOCUMENTATION (TD) The
technical documentation must be prepared by the manufacturer. The TD must enable the assessment of the product’s conformity with the requirements of Government Regulation No. 116/2016 Coll., and an appropriate risk analysis and assessment is an integral part thereof. Minimum content of the technical documentation: a general description of the product; conceptual design, manufacturing drawings, and diagrams of components, subassemblies, and circuits; descriptions and explanations to aid in understanding the drawings, diagrams, and operation of the product; a list of harmonized standards that have been applied in full or in part; if harmonized standards have not been applied—a description of the solution chosen to meet the essential technical requirements under Government Regulation No. 116/2016 Coll., including a list of other relevant technical specifications used; an indication of those parts of the harmonized standards that were used only partially; results of design calculations and tests performed; test reports. The manufacturer, or its authorized representative, shall keep the technical documentation for a period of at least 10 years from the date the product was placed on the market.

FORMAL
DEFICIENCIESFormal deficiencies are listed in Section 14 of Government Regulation No. 116/2016 Coll. If these formal deficiencies are not remedied, the supervisory authorities may decide to prohibit the supply of the product to the market, its putting into service, or to withdraw the product from the market or from circulation.

TRANSITIONAL
PROVISIONSProducts placed on the market before April 20, 2016, under the former Government Regulation No. 23/2003 Coll. may continue to be supplied to the market and put into service. Valid certificates and other documents issued by notified bodies under Government Regulation No. 23/2003 Coll. remain valid and are considered certificates and other documents under Government Regulation No. 116/2016 Coll.