Regulations on equipment and safety systems for use in hazardous areas


Date FOR-1996-12-09-1242


Affairs Ministry of Justice, Labour and Social Affairs


Published Dept. In 1996 2096


Commencement 01.01.1997

Edited

FOR 2016-04-19-398 from 20/04/2016

Changes


For
Norway

Legal

LOV-1929-05-24-4-§10, LAW-1929-05-24-4-§11, LOV-1971-05-21-47-section 6, TO-1996-12-04- 1122, LOV-2002-06-14-20-L-26, LOV-2002-06-14-20-§43, LOV-2002-06-14-20-§44, TO-2002-05-23-770 , LOV-2005-06-17-62-5-5, FOR-2003-09-01-1161

Promulgated


Short Title
Regulations on hazardous area

Chapter Overview:

Chapter I. Introductory provisions (§§ 1-8)
Chapter II. Provisions on labeling, documentation, conformity assessment etc. (§§ 9-16)
Chapter III. Conformity assessment bodies (§§ 17-23)
Appendix I. Criteria for classifying device groups into categories
Appendix II. Basic requirements for health and safety relating to the design, construction and production of equipment and safety systems for use in ...
Appendix III. Module B: EC type examination
Annex IV. Module D: Conformity to type based on quality assurance of the production process
Annex V. Module F: Conformity to type based on product verification
Annex VI. Module C1: Conformity to type based on internal production control plus supervised product testing
Annex VII. Module E: Conformity to type based on quality assurance of products
Annex VIII. Module A: Internal production control
Annex IX. Module G: Conformity based on unit verification
Annex X.

Adopted by the Directorate of Labour Inspection, the Directorate for Fire and Explosion Prevention and Product and Electricity Authority (now Directorate for Civil Protection and Emergency Planning) December 9, 1996 pursuant to Law 24 May 1929 no. 4 regarding inspection of electrical installations and electrical (el-Supervision) § 10 cf. § 11, Act 4 February 1977 no. 4 relating to worker protection and working environment § 17 and law 21 May 1971 No.. 47 for flammable goods, liquids and gases under pressure § 6, second paragraph and administrative decisions on 4 December 1996. 1122.
Added basis: law of 14 June 2002 no. 20 relating to protection against fire, explosion and accidents involving hazardous substances and the fire service (fire and explosion Act) § 26, § 43, ref. § 44; see. delegated decision of 23 May 2002 no. 770 and delegated decision of 26 June 2002 no. 728. Act 17 June 2005 no. 62 relating to the working environment, working hours and employment etc. (Working Environment Act) § 5-5. Delegation Decision on 1 September 2003 no. 1161.
EEA information: EEA Agreement, Annex II, Ch. X (Directive 94/9 / EC), ref. Joint Committee Decision No. 14, 28 October 1994, no. 7f (Directive 2014/34 / EU) art. 13, 21, 22, 23, 24, 27 no. 1, 29, 31, 41 and Annex III-IX, ref. Joint Committee Decision No. 46, 18 March 2016.
Changes: Amended by regulations 10 July 2002 No.. 818, 8 Dec 2003 no. 1458, 4 Dec 2015 no. 1396, 19 april 2016 No.. 398.

Chapter I. Introductory provisions

§ 1. Scope These regulations apply to equipment and safety systems for use in hazardous areas, and produced, set in turnover and is used in the EEA.
Regulations apply equivalent safety device, control device and control device for use outside the hazardous area, but that is necessary for, or contribute to, safe functioning of equipment and safety in connection with the explosion.
Regulation also applies to components above.
Regulation does not:

-
Medical devices for use in medical environments,

-
Equipment and safety systems for use where the explosion risk is solely due to the occurrence of explosive substances or unstable chemical substances,

-
Products intended for use in residential and non-commercial areas where an explosive atmosphere only rarely occurs, and in that case only as a result of an accidental gas leak,

-
Personal protective equipment covered by the provisions of regulations on construction, design and manufacture of personal protective equipment laid down on 19 August 1994 no. 819,

-
Seagoing vessels and mobile offshore units and equipment on board these vessels and facilities,

-
Transport, ie vessels and vehicles and their trailers, must be used exclusively for passenger transport in the air, road and rail networks or over water, and transportation provided used for freight transport in air, road and rail networks, or water. Vehicles and vessels, must be used in hazardous areas are not exempt,

-
Weapons, munitions and war material for military purposes.

Regulations apply to Svalbard.

§ 2. Definitions In this Regulation:

Equipment and protective etc. for use in hazardous areas:
Equipment: Machinery, apparatus, fixed or mobile units, controls and instruments, warning systems and prevention systems, which alone or in combination is intended for use in the production, transmission, storage, measurement, regulation and transformation of energy and processing of materials, and that have potential ignition sources which may cause an explosion.
Security: Adaptations except components for the equipment mentioned above, which is supposed to immediately stop an incipient explosion and / or restrict the area affected by an explosion, and inserted in revenue separately as system with independent function.
Components: Parts that are important for the equipment and safety systems to function safely, but that does not have an independent function.
Explosive atmosphere Mixture, under atmospheric conditions, of air and flammable substances in the form of gases, vapors, mists or dust where combustion spreads to the entire unburned mixture after ignition.
Hazardous Area: Area where an explosive atmosphere is or may be present in such quantities that it required special measures in connection with, inter alia, construction, installation and use of electrical equipment or other sources of ignition.
Intended Use: The use of equipment and safety systems, etc. in accordance with the equipment group and equipment category, and with all the information specified by the manufacturer, and which are necessary for equipment and safety systems, etc. can operate safely.

§ 3. Who the Regulations target manufacturer or his authorized representative shall ensure that the requirements of this regulation are met. Importer, distributor and others who put in revenue such products are responsible for ensuring that they do not put on the market products not in compliance with requirements of the regulations.
Conformity assessment bodies and notified bodies shall ensure that the relevant requirements of the regulation are met.

§ 4. Supervisory authority Directorate for Civil Protection and Emergency Planning and the Directorate of Labour Inspection is the supervisory authorities in accordance with the respective legal laws.

§ 5. Exemptions Exemptions from this regulation may be granted by the respective regulatory authority if special circumstances and the exemption does not conflict with the EEA Agreement.

§ 6. Appeals Appeals against decisions taken by this regulation should be addressed to the authority which is immediately superior to the body that made the decision.
Complaint sent through the body that made the decision, Administration Sec. 6

§ 7. Penal provision Violation of these regulations or decisions made in pursuance thereof may be punished by:

-
Act of 24 May 1929 concerning inspection of electrical installations and electrical equipment § 14

-
Act of 17 June 2005 no. 62 relating to the working environment, working hours and employment etc. Chapter 19, where the violation is made by undertakings under the Working Environment Act and the conduct of business activities.

-
Law 21 May 1971 No.. 47 for flammable goods, liquids and gases under pressure § 44,

-
Act of 14 June 2002 No.. 20 concerning protection against fire, explosion and accidents involving hazardous substances and the fire service § 42

-
Law of 20 May 2005 no. 28 on penalties § 27 and § 28

§ 8. Commencement and transitional provisions This Regulation shall enter into force on 1 January 1997.
Until 30 June 2003 accepted as an alternative to the requirements of these regulations the requirements that were applicable for the product concerned by Regulation came into force.
Products covered and which are in compliance with these regulations and which are placed on the market before 20 April 2016, may be made available on the market.
Certificates issued in accordance with these regulations prior to the amendment on 20 April 2016, the effect even after April 20, 2016.

Chapter II. Provisions on labeling, documentation, conformity assessment etc.

§ 9. Conditions for putting on the market products covered by these regulations can be put in sales and is used if the requirements of this regulation are met, including the safety requirements in Annex II. This must be documented in the manner prescribed for the product in question in § 14 CE marking shall be applied unless exempted from this requirement.
Product that does not meet the requirements of Annex II, or who do not have evidence that it meets current safety standards, may still be displayed at trade fairs, exhibitions, demonstrations, etc., provided that it clearly indicated that the product does not meet these regulations, and that product therefore can not be put on the market or put into service.

§ 10. Security Requirements Products covered by this regulation shall comply with the requirements for safety and health set out in Annex II which apply to them, taking into account the intended use.

Declaration etc. shall be based on the classification of equipment group and equipment category and conformity assessment as described in § 14 and in Annex I.
Products that are intended for use in defined explosive atmosphere or in specified conditions must be clearly marked so that this clearly appears from the label.
Information necessary for safe operation in accordance with its purposes, shall be in Norwegian and be caused to the product or, if this is not possible, be included in an accompanying manual.

§ 11. Assuming that the safety requirements are met Product performed in accordance with harmonized standards, or national standards that implement this, and that it is made public reference to the Official Journal, deemed to fulfill the requirements of Annex II Additional product concerned standard covers.
If there is no harmonized standard for a product to national standards in the EEA assumed when the competent national authorities have declared that the standard will meet the requirements of Annex II of the product concerned standard covers.

§ 12. CE Marking Each copy of the equipment and safety systems, etc. shall bear the CE marking as a confirmation that it meets all relevant requirements of the Directive. However, required no CE marking of components.
CE marking shall be performed by the manufacturer or his authorized representative in the EEA.
CE marking shall consist of the initials "CE" in the graphic design that is shown in Annex X. If the notified body has carried out production control shall body's identification number shall be added CE marking.
CE marking shall be in addition to no. 1.0.5. Annex II is applied to equipment and safety systems, etc. so that it is visible, easy to read and indelible.
It is prohibited to affix labels on equipment and safety, etc. that may mislead third parties with regard to CE-mark the meaning and form design. Any other marking may be affixed to equipment and safety, etc., provided that it does CE marking less visible or difficult to read.
If the equipment or protective covered by other regulations concerning other aspects which also establishes requirements for CE marking, the CE marking shall indicate that the product also meets the requirements of these other regulations.
If one or more of these regulations for a transitional period allowing the manufacturer is free to choose which rules applied, specifies CE marking only that the product complies with the provisions of the legislation manufacturer has applied. In such case, these regulatory reference number, as published in the Official Journal, and that the regulations in question are based, are given in the documents, notices or instructions required by the regulations.

§ 13. Documentation that the safety requirements are met documentation as required by § 14 shall be drafted and signed by the manufacturer or his authorized representative in the EEA.
Whoever for use in Norway producing or introducing the equipment and safety, etc. for use in hazardous areas is responsible for the copy of the Declaration may be submitted to the regulatory authorities within three working days.
Whoever for use in Norway producing or introducing the equipment and safety, etc. for use in hazardous areas is responsible for specified parts of the technical documentation can be submitted to the regulatory authorities within a reasonable time after notice thereof.
Requirement availability of Conformity and technical documentation apply even ten years after the product was put into circulation.

§ 14. Procedures for conformity assessment procedures for conformity assessment of equipment and, possibly, the devices referred to in § 1, second paragraph is as follows:

A)
for equipment group I and II, equipment category M 1 and 1, EC type examination set out in Annex III in combination with one of the following:

-
Conformity to type based on quality assurance of the production process, as set out in Annex IV,

-
Conformity to type based on product verification, as set out in Annex V,

B)
for equipment group I and II, equipment category M 2 and 2:

I)
for internal combustion engines and electrical equipment in these groups and categories, EC type examination set out in Annex III in combination with one of the following:

-
Conformity to type based on internal production control and supervised product testing, as specified in Annex VI,

-
Conformity to type based on quality assurance of products, as set out in Annex VII,

Ii)
for other equipment in these groups and categories, internal production control as set out in Annex VIII and the presentation of the technical documentation referred to in paragraph. 2 of Annex VIII for a notified body, which users should confirm that the documentation is received and shall keep it,

C)

For equipment group II, equipment category 3, internal production control as set out in Annex VIII,

D)
for equipment group I and II, in addition to the procedures set forth in subparagraph a-c, also used matches based on unit verification as set out in Annex IX.

Procedure mentioned in the first paragraph a or d should be applied in conformity assessment of safety systems.
The procedures mentioned in the first paragraph shall also apply to components, with the exception of the application of the CE marking and preparation of the DoC. The manufacturer shall issue a written declaration certificate declaring that the components are in accordance with relevant provisions of the regulation, which also disclosed component characteristics and how they should be incorporated into equipment or security systems to help comply with the basic requirements of health and safety as set out in Annex II and apply to finished equipment and finished security systems.
With regard to the safety conditions referred to in paragraph. 1.2.7 of Annex II, the procedure in Annex VIII also be followed as an addition to the conformity assessment procedures in subsections.
Derogation from the first, second and fourth paragraphs, the Labour Inspectorate and the Directorate for Civil Protection and Emergency Planning, by a duly substantiated request, allow products that are not components, and that the procedures mentioned in the first, second and fourth paragraphs have not been applied to, placed on the market and put into use in Norway if the products are used for security purposes.
Documents and correspondence relating to conformity assessment procedures referred to in subsections must be written in Norwegian or English.

§ 15. Control Testing equipment supervisory authorities may, when deemed necessary, take out samples of the product in accordance with the laws of this the regulation.

§ 16. Withdrawal from the market and ban on trade in products Finds a supervisory authority that safety requirements are not met for a product, the competent supervisory authority prohibit further sales, and require that products traded withdrawn and possibly discarded. The same applies if the documentary requirements in § 13 are not met or it is bearing the CE marking contrary to the conditions for use of CE marking.
If a product by the Financial Regulator opinion can be dangerous to people, pets or property, the supervisory authority may require any person who has produced or put the product in revenue recalling it from those who have acquired or started using it. The supervisory authority may require the recalled product discarded.
In cases where it is demonstrated minor deviations from the requirements may instead be given an appropriate time limit for correction.

Chapter III. Conformity assessment bodies

§ 17. Application for designating conformity assessment bodies that will be Notified Body for these regulations shall apply Directorate for Civil Protection and Emergency Planning.
Conformity assessment body shall by its designation, fulfill the requirements of § 18
application shall be accompanied by a description of the conformity assessment activities, the person or conformity assessment modules and or the products which it claims to be competent for, as well as an accreditation certificate issued by Norwegian accreditation certifying that conformity assessment body meets the requirements set out in § 18
If conformity assessment body can not produce an accreditation certificate, it shall provide the supervisory authority the documentation required to verify, recognize and regular monitoring of the body meets the requirements of § 18 .
If a notified body does not meet its obligations, the Directorate for Civil Protection and emergency Planning limit or revoke the designation.

§ 18. Requirements for notified bodies a conformity assessment body shall be established in accordance with Norwegian law and have legal personality.
A conformity assessment body shall be a third-party body that is independent of the organization or the product it assesses.
A body belonging to a business nor professional organization representing undertakings involved in the design, manufacture, delivery, installation, use or maintenance of products which it assesses, may be considered such a body, assuming it is proven that the body is independent and that there are no conflicts of interest.
A conformity assessment body, its top management and personnel responsible for carrying out conformity assessments, should not be those that designs, manufactures, supplies, installs, buyer, owner, user or maintainer of products they assess, nor be representative any of these parties. This shall not preclude the use of assessed products that are necessary for the conformity assessment body's activities or use of such products for personal purposes.

A conformity assessment body, its top management and personnel responsible for carrying out conformity assessments, should not be directly involved in the design, manufacture, marketing, installation, use or maintenance of products, nor represent the parties participating in such activities. They shall not engage in any activities which may affect their independence of judgment or integrity in relation to conformity assessment activities they are designated. This will particularly apply to consulting services.
Conformity assessment bodies shall ensure that their subsidiaries or subcontractors operations do not affect the confidentiality, objectivity or impartiality of bodies conformity assessment activities.
Conformity assessment bodies and their personnel to perform the conformity assessment activities with the greatest professional integrity and have the necessary technical qualifications in the relevant field, and they shall not be subjected to any form of pressure or influence, particularly financial, which may affect their ratings or the results of their conformity assessment activities, especially from persons or groups of persons affected by the results of this business.
A conformity assessment body shall carry out all the conformity assessment tasks assigned to it in accordance with Annex III to VII and Annex IX, and which it is designated. This applies whether these tasks are carried out by the conformity assessment body itself or on its behalf and responsibility.
A conformity assessment body shall at all times and for each conformity assessment procedure and each kind or category of products as it is designated for, at his disposal

A)
necessary personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment

B)
descriptions of conformity assessment procedures that ensure transparency and the ability to repeat these procedures. The body shall have appropriate policies and procedures to distinguish between tasks it carries out as a notified body and other activities,

C)
necessary procedures for the execution of the business, taking due account of the entity's size, the sector in which it conducts its business, its structure, the complexity of the current product technology and production process mass or serial touch.

A conformity assessment body shall have the necessary funds in a suitable manner to perform the technical and administrative tasks connected with the conformity assessment activities, and shall have access to all necessary equipment and amenities.
Personnel responsible for performing compliance reviews should have

A)
solid technical and vocational training covering all the conformity assessment activities that conformity assessment body is designated,

B)
satisfactory knowledge of the requirements for the opinions they perform, and the necessary powers to carry out such assessments,

C)
satisfactory knowledge and understanding of the essential health and safety requirements of Annex II, the relevant harmonized standards and relevant provisions of the EEA harmonization legislation and national legislation,

D)
the necessary qualifications to draw up the certificates, records and reports demonstrating that assessments have been performed.

It must be ensured that the conformity assessment bodies, their top management and personnel responsible for carrying out conformity assessments are impartial.
Remuneration to a conformity assessment body's top management and the personnel responsible for carrying out conformity assessments shall not be dependent on the number of completed evaluations or the results of such assessments.
Conformity assessment bodies shall take out liability insurance unless the state assumes responsibility or even directly responsible for the conformity assessment.
Conformity assessment Authority personnel shall be subject to confidentiality with regard to all information they collect when they perform their duties in accordance with Annex III to VII and Annex IX or any provision of national law giving effect except against supervisory authorities. Property rights must be protected.
Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out conformity assessments are apprised of relevant standardization activities and the activities of the coordination group for notified bodies established under the relevant parts of the EEA harmonization legislation, and shall apply the administrative decisions and documents that this group work culminates in, as general guidelines.


§ 19. Assumption on technical inspection bodies conformity Where a conformity assessment body demonstrates that it meets the criteria laid down in the relevant harmonized standards or parts thereof, that have been published references in the Official Journal, shall be presumed to meet the requirements of § 18 to the extent that the relevant harmonized standards cover these requirements.

§ 20. Technical inspection bodies subsidiaries and subcontractors If a Notified Body assigns specific tasks relating to conformity assessment of a subcontractor or a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements of § 18 and notify the Directorate for Civil Protection and Emergency Planning about this .
Notified bodies shall assume full responsibility for the tasks performed by subcontractors or subsidiaries, wherever these are established.
Tasks can be assigned to a subcontractor or a subsidiary only if the customer has given his consent.
Notified bodies shall keep at the disposal of Directorate for Civil Protection and Emergency Planning relevant documents on the assessment of the subcontractor's or subsidiary's qualifications and the tasks they performed in accordance with Annex III to VII and Annex IX.

§ 21. Technical inspection bodies operational commitments Notified bodies shall carry out conformity assessments for conformity assessment procedure set out in Annex III to VII and Annex IX.
Conformity assessments shall be carried out in a manner proportionate to the goal, so that market participants are not imposing unnecessary burdens. Conformity assessment bodies shall conduct its operations so that due consideration is given to the size of the entity, the sector in which it conducts its business, its structure, the complexity of the current product technology and production process mass or serial touch. In this connection they shall nevertheless comply with the degree of rigor and the level of protection required for the product to comply with the requirements of the regulations.
If a notified body finds that a producer has not complied with the basic health and safety requirements of Annex II or corresponding harmonized standards or other technical specifications, it shall require the manufacturer to take appropriate corrective measures, and did not issue a certificate of conformity.
If a Notified Body in connection with verification of compliance by the issuance of a certificate finds that a product no longer complies with the requirements, it shall require the manufacturer to take appropriate corrective action, if necessary, suspend or revoke the certificate.
If no corrective action is taken, or if they do not have the desired effect, the notified body restrict, suspend or withdraw any certificates back, whichever is appropriate.

§ 22. Technical inspection bodies reporting obligation Notified bodies shall inform the Directorate for Civil Protection and Emergency Planning on

A)
all cases of refusal, restriction, suspension or withdrawal of a certificate

B)
all circumstances affecting the scope or terms of appointment,

C)
all requests they have received from regulatory authorities for information on conformity assessment activities,

D)
on request, conformity assessment activities performed within the scope of the designation, and any other activity that is exercised, including activity and subcontracting across borders.

§ 23. Technical inspection bodies information duty Notified bodies shall provide the other bodies designated for the region and performing similar forms of conformity assessment involving the same products, all relevant information on issues relating to negative and, on request, positive results conformity assessments.

Appendix I. Criteria for classifying device groups into categories

1. Equipment Group I

A)
Category M 1 comprises equipment designed and, if necessary, additionally provided with special associated protective devices, in order to act 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 as well as those mines surface installations to be endangered by firedamp and / or combustible dust.
Equipment in this category must, even in the event of rare incidents relating to equipment, be an explosive atmosphere and be provided with protective devices such

-
That the failure of one means of protection, at least one other independent protective means provides the requisite level of protection,

-

Or the event of two wrong independently, that the requisite level of protection, are secured.

Equipment in this category must comply with the supplementary requirements referred to in Annex II. 2.0.1.

B)
Category M 2 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a high level of protection.

Equipment in this category is intended for use in underground parts of mines as well as those mines surface installations to be endangered by firedamp and / or combustible dust.
The energy supply of this equipment will be broken in the event of an explosive atmosphere.
Means of protection relating to equipment in this category ensure that the equipment meets the requisite level of protection during normal operation and under more severe operating conditions, in particular those arising from rough handling and changing environmental conditions.
Equipment in this category must comply with the supplementary requirements referred to in Annex II. 2.0.2.
2. Equipment Group II

A)
Category 1 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a very high level of protection.

Equipment in this category is intended for use in areas where it continuously, for long periods or frequently occurring explosive atmospheres caused by a mixture of air and gases, vapors, mists or dusts.
Equipment in this category must, even in the event of rare incidents relating to equipment, be an explosive atmosphere and be provided with protective devices such

-
That the failure of one means of protection, at least an independent second protection means provides the requisite level of protection,

-
Or the event of two wrong independently, that the requisite level of protection, are secured.

Equipment in this category must comply with the supplementary requirements referred to in Annex II. 2.1.

B)
Category 2 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a high level of protection.

Equipment in this category is intended for use in areas where there are likely to occur explosive atmosphere caused by a mixture of air and gases, vapors, mists or dusts.
Means of protection relating to equipment in this category ensure that the equipment meets the requisite level of protection, even in the event of frequent disturbances or equipment faults which normally have to be assumed.
Equipment in this category must comply with the supplementary requirements referred to in Annex II. 2.2.

C)
Category 3 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a normal level of protection.

Equipment in this category is intended for use in areas where the risk of occurrence of an explosive atmosphere caused by a mixture of air and gases, vapors, mists or dust is unlikely and, if explosive atmosphere occurs only infrequently, and when the occurs only for a short time.
Equipment in this category ensures the requisite level of protection during normal operation.
Equipment in this category must comply with the supplementary requirements referred to in Annex II. 2.3.

Appendix II. Basic requirements for health and safety relating to the design, construction and production of equipment and safety systems for use in hazardous areas

Introductory remarks
A. It must as far as possible taking into account the technological expertise that can be developed quickly, and as soon as possible must be used.
B. For devices referred to in § 1, 2nd paragraph are the basic requirements apply only to the extent they are essential if the installations can function and be operated safely and reliably for explosion.

1. Common requirements for equipment and protective

1.0.
General requirements

1.0.1.
Principles of integrated explosion safety

Equipment and protective intended for use in potentially explosive atmospheres must be designed with the aim of integrated explosion safety.
Manufacturer must in that regard take measures

-
Primarily to prevent equipment and safety even produced or released by explosive atmospheres

-
To prevent explosive atmosphere is ignited, as all sources of ignition, electric and non-electric, should be considered,

-
That an explosion, if it does occur and directly or indirectly endanger persons, animals or property in danger, stopped immediately and / or that the area affected by flames and pressure from the explosion limited to an acceptable level of security.

1.0.2.
Equipment and protective systems must be designed and manufactured, having regard to any malfunctions, so that dangerous situations as far as possible be avoided.

Consideration should be given to possible misuse which can reasonably be expected.


1.0.3.
Special checking and maintenance conditions

Equipment and protective systems subject to special checking and maintenance conditions must be designed and manufactured, having regard to these provisions.

1.0.4.
Ambient conditions

Equipment and protective systems must be designed and manufactured, having regard to existing and expected ambient conditions.

1.0.5.
marking

All equipment and protective systems shall be the following markings, which must be easy to read and could not be removed:

-
Manufacturer's name and address,

-
CE marking (see Annex X, point A)

-
Series or type designation,

-
Any serial numbers,

-
Manufacture,

-
The specific explosion protection mark.


Followed by the symbol of the equipment group and category,

-
For equipment group II, the letter "G" (for explosive atmospheres caused by gases, vapors or mists),

And / or

-
Letter "D" (for explosive atmospheres caused by dust).

Equipment and protective systems must also be supplied with all information required in the interests of user safety.

1.0.6.
Instructions

A)
All equipment and protective systems must be accompanied by a manual containing at least the following information:

-
Recapitulation listed for marking, except for the serial number (see Section 1.0.5) as well as any additional information to facilitate maintenance (eg. The importer / repairer address etc.)

-
Guidance for safe

-
Placing,

-
Use

-
Assembly, disassembly,

-
Maintenance (ongoing maintenance and repair)

-
Installation

-
Adjustment

-
If necessary indication of danger areas in front of pressure relief devices,

-
If necessary, training instructions,

-
The directions necessary for satisfactory basis to determine whether the equipment in a given category or a security system can be used without danger to the intended place and under the expected conditions,

-
Parameters of electricity and pressure, maximum surface temperatures and other limit,

-
If necessary, special conditions of use, including specification of misuse which experience can occur,

-
If necessary, the essential characteristics of tools which can be mounted on equipment or protective system.

B)
instructions must be drawn in one of the Community languages ​​by the manufacturer or his authorized representative in the EEA.

When equipment or protective system is used, there must be a translation of the instructions in the language or languages ​​of the country.
Translation must be made by the manufacturer or his authorized representative in the Community or the person introducing the equipment or protective system into the language area.
Maintenance instructions that are only intended for use by the specialist personnel employed by the manufacturer or his authorized representative may be drawn up in a single Community language understood by that personnel.

C)
The instructions must contain the drawings and diagrams necessary for putting into service, maintenance, inspection, checking of correct operation and any repair of the equipment or protective system, together with all useful instructions, in particular on security.

D)
Documentation about equipment or protective system must not contradict the instructions with regard to safety aspects.

1.1.
Material choice

1.1.1.
Materials used for the construction of equipment and protective systems must not trigger off an explosion, taking into account the expected operating conditions.

1.1.2.
Within limits of the operating conditions established by the manufacturer, shall not be between the materials used and the constituents of the potentially explosive atmospheres could occur reactions resulting 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 reduction in the protection weakened, particularly with regard to the material's corrosion and wear resistance, electrical conductivity, impact strength, aging and effects of temperature variations.

1.2.
Design and construction

1.2.1.
Equipment and protective systems must be designed and constructed with due regard to technological knowledge of explosion protection so that they can be safely operated throughout their foreseeable lifetime.

1.2.2.
Components to be incorporated into or used as replacements in equipment and protective systems must be so designed and constructed that they function safely in accordance with the intended use when installed according to the manufacturer's instructions.

1.2.3.

Enclosed structures and prevention of leaks

Equipment which may release flammable gases or dusts must wherever possible employ enclosed structures.
If equipment contains openings or unsealed joints, these must as far as possible, be designed so that emissions of gases or dust does not lead to explosive atmospheres outside the equipment.
Openings for filling and emptying should be designed so that the release of flammable substances in the greatest extent possible for filling and discharge.

1.2.4.
Dust deposits

Equipment and protective used in areas exposed to dust must be so designed that deposit dust on their surfaces is not ignited.
Dust deposits must be limited where possible. Equipment and protective systems must be easily cleaned.
The surface temperatures of equipment parts must be kept well below the glow temperature of the deposit dust.
Consideration should be given to the thickness of deposit dust, and if necessary measures are taken to limit the temperature in order to prevent a heat build.

1.2.5.
Additional means of protection

Equipment and protective that can be subject to external influence, should if necessary be provided with additional means of protection.
Equipment must withstand relevant stresses, without explosion protection.

1.2.6.
Safe opening

If equipment and protective systems are in a housing or forming part of the explosion protection itself, should housing or container could only be opened using special tools or after appropriate protection measures.

1.2.7.
Protection against other hazards

Equipment and protective systems must be designed and constructed so that

A)
there is no danger of bodily harm or other damage by direct contact,

B)
surface temperatures of accessible parts or radiation which may endanger not occur,

C)
dangers of non-electrical character which from experience can occur, avoided

D)
expected load does not lead to a dangerous situation.

When the hazards associated with equipment and safety mentioned in this paragraph entirely or partly covered by other provisions, get this point does not apply to such equipment, such security and such risks upon application of those specific Directives.

1.2.8.
Overloading of equipment

Dangerous overloading of equipment must be prevented at the design stage by means of integrated measurement, control and adjustment which, overcurrent switches, thermostats, differential pressure switches, flow meters (flow meters), time-lag relays, overspeed monitors and / or similar types of monitoring devices.

1.2.9.
Explosion proof execution

If parts which can ignite an explosive atmosphere are placed in an enclosure, it shall ensure that the enclosure withstands the pressure developed during an internal explosion of an explosive mixture inside the equipment and prevent the explosion propagates to the explosive atmosphere surrounding the enclosure .

1.3.
Potential ignition sources

1.3.1.
Hazards arising from different ignition sources

There must not be any potential ignition sources such as sparks, flames, electric arcs, high surface temperatures, acoustic energy, optical radiation, electromagnetic waves and other ignition sources.

1.3.2.
Hazards arising from static electricity

Electrostatic charges capable of resulting in dangerous discharges must be prevented.

1.3.3.
Dangers caused by improper flow or leakage

It must be prevented that in the equipment's electrical components occurring fault current and leakage current which may for example involve dangerous corrosion, overheating of the surface or sparks that may cause ignition.

1.3.4.
Hazards arising from overheating

Overheating caused by friction or impact, for example. between materials and rotary parts or because of foreign bodies must, as far as possible be avoided.

1.3.5.
Hazards of pressure equalization

Equipment and security system must be so designed or have built-in measurement, control and regulating means which ensures pressure equalization can take place in such a way that there is formed shock waves or pressure (pitch) that can cause ignition / explosion.

1.4.
Hazards arising from external effects

1.4.1.
Equipment and protective systems must be designed and manufactured so that the full safety capable of performing their intended function, even if the ambient exposed to conditions in terms of changes in ambient conditions, fault current, humidity, vibrations, pollution, etc., within the limits established by the manufacturer for operating conditions.

1.4.2.

Equipment parts used must be appropriate to the intended mechanical and thermal stresses and capable of withstanding attack from substances that are present or expected to occur.

1.5.
Equipment requirements that contribute to the security

1.5.1.
Safety devices must function independently of any measurement and control devices required for operation.

Error in a safety device must be using appropriate technical measures to the maximum detected sufficiently rapidly so that only a very small probability that a dangerous situation occurs.
As a rule, the principle of active safety (failsafe principle) is used.
Safety must in general directly on the relevant control devices, except for software.

1.5.2.
Upon failure of a safety device, the equipment and / or safety as far as possible, be secured.

1.5.3.
Emergency stop devices must, as far as possible be provided with blocking, so that the restart may not occur. A new start command may only be able to start the machine if the barrier against restarting previously been reset by an intentional action.

1.5.4.
Control and display units

Where control and display units shall be ergonomic suitably designed so that the greatest possible operational reliability with regard to the risk of explosion.

1.5.5.
Requirements for devices with a measuring functions, for explosion

Devices with a measuring function must, to the extent that they are used in connection with equipment used in an explosive atmosphere, be designed and manufactured taking into account the foreseeable operating requirements and special conditions that they are used under.

1.5.6.
If necessary, devices with measuring functions to check the reading accuracy and functionality.

1.5.7.
The design of devices with a measuring function must incorporate a safety factor which ensures that the alarm threshold lies far enough outside the explosion and / or ignition limits of the atmosphere, taking into consideration the operating conditions of and possible aberrations in the measuring system.

1.5.8.
Risks arising from software

When designing the computerized equipment and computerized systems and safety devices, special account must be taken of the risks arising from faults in the program.

1.6.
Security System requirements

1.6.1.
Equipment and protective systems that are part of an automated process must be stopped manually in a safe way if the operating conditions change beyond the intended limits, provided that safety this does not compromise.

1.6.2.
When the emergency shutdown system is actuated, accumulated energy must be dissipated as quickly and safely as possible or isolated so that it no longer constitutes a hazard.

This does not apply to electrochemically-stored energy.

1.6.3.
Dangers caused by power failure

Where equipment and protective power failure can lead to the emergence of new risks that may propagate, to be maintained in safe operating independently of the rest of the plant.

1.6.4.
Hazards arising from connections

Equipment and protective systems must be fitted with suitable cable and conduit entries.
When using equipment and safety in combination with other equipment and protective systems, the coupling / connection be sure.

1.6.5.
Placement of warning devices

When equipment or protective systems warning or alarm devices for monitoring the occurrence of an explosive atmosphere, make it necessary instructions to make it possible to place them in the correct place.

2. Additional Equipment Requirements

2.0.
Requirements for equipment of Group I

2.0.1.
Requirements for equipment of Group I, Category M

2.0.1.1.
Such equipment shall be designed and constructed so that ignition sources can not occur. This also applies to rarely occurring incidents relating to equipment.

It shall be provided with several different protective devices against explosion so

-
The event of failure of one means of protection, at least an independent second protection means provides the requisite level of protection,

-
Or the event of two wrong independently, that the requisite level of protection, are secured.

If necessary, such equipment can be provided with special additional means of protection.
Protection devices must be able to operate safely in an explosive atmosphere.

2.0.1.2.
Equipment shall, if necessary, be prepared so that dust can not penetrate it.

2.0.1.3.

The surface temperature of equipment parts must, in order to prevent dust swirled up ignite, be significantly lower than the ignition temperature of the dust-air mixtures can be expected.

2.0.1.4.
Equipment shall be constructed so that parts of it that could be an ignition source, can only be opened when the power supply is broken, or these parts are otherwise inactivated. If the equipment can not be inactivated, the manufacturer must affix a warning on the part of the equipment that open.

Equipment shall if necessary also be provided with suitable locking devices / interlocks.

2.0.2.
Requirements for equipment of Group I, Category M 2

2.0.2.1.
Equipment must be provided with protective devices which ensure that ignition sources can not be activated during normal operation and under severe operating conditions, in particular those which may arise as a result of heavy loads or use under varying ambient conditions.

Power supply for this equipment to be interrupted in case it occurs explosive atmosphere.

2.0.2.2.
Equipment shall be constructed so that parts of it, which could be an ignition source, can only be opened when power is interrupted or equivalent safety is achieved by means of suitable locking devices / interlocks. If the equipment can not be inactivated, the manufacturer must affix a warning on the part of the equipment that open.

2.0.2.3.
Protective measures against explosions due to the presence of dust, shall meet the same requirements as those applicable to equipment in category M 1

2.1.
Requirements for equipment group II, Category 1

2.1.1.
Explosive atmosphere formed by gases, vapors or mists

2.1.1.1.
Equipment must be designed and manufactured so that ignition sources can not occur, even when the event of rare incidents relating to equipment.

Shall be provided with several different protective measures so

-
The event of failure of one means of protection, at least an independent second protection means provides the requisite level of protection,

-
Or the event of two faults independently, that the requisite level of protection, are secured.

2.1.1.2.
For equipment with surfaces which may heat up, it shall be ensured that the specified maximum surface temperatures are not exceeded, even under the most adverse conditions.

The temperature rise due to heat accumulation and chemical reactions must also be taken into consideration.

2.1.1.3.
Equipment must be so designed that part of it that could be an ignition source, can only be opened when the power supply is interrupted, or inactive or intrinsically safe conditions. If the equipment can not be inactivated, the manufacturer must supply the pieces of equipment that can be opened with a warning.

Equipment shall if necessary also be provided with suitable locking mechanisms.

2.1.2.
Explosive atmosphere caused by the presence of dust-air mixtures

2.1.2.1.
Equipment must be designed and manufactured so that ignition of dust-air mixtures can not happen, even if the exception occurs malfunction.

It shall be provided with protective devices such

-
That the failure of one means of protection, at least an independent second protection means provides the requisite level of protection,

-
Or the event of two wrong independently, that the requisite level of protection, are secured.

2.1.2.2.
Equipment shall, if necessary, be designed so that dust can penetrate or dropping out only in places intended for this.

The same requirements apply to cable entries and transition pieces.

2.1.2.3.
To prevent ignition of dust swirled up, the device surface temperature will be significantly lower than the ignition temperature of the dust-air mixtures can be expected.

2.1.2.4.
The requirements of paragraph 2.1.1.3. also applies to the opening of the equipment.

2.2.
Requirements for equipment group II, category 2

2.2.1.
Explosive atmosphere formed by gases, vapors or mists

2.2.1.1.
Equipment must be designed and manufactured so that sources of ignition avoided by frequent disturbances or malfunction of the equipment normally be expected.

2.2.1.2.
Equipment parts used must be designed and manufactured so that the surface temperature does not exceed what is allowed, not even in connection with the risks arising from abnormal situations which the manufacturer has foreseen.

2.2.1.3.
Equipment shall be constructed so that parts of it that could be an ignition source, can only be opened when the power supply is interrupted, or by appropriate blocking systems. If the equipment can not be inactivated, the manufacturer must affix a warning on the part of the equipment that open.

2.2.2.
Explosive atmosphere caused by the presence of dust-air mixtures

2.2.2.1.

Equipment must be designed and manufactured so that dust-air mixtures not ignite even at frequent disturbances or malfunction of the equipment normally be expected.

2.2.2.2.
The requirement of paragraph 2.1.2.3 shall apply with regard to surface temperatures.

2.2.2.3.
The requirement of paragraph 2.1.2.2 shall apply with regard to protection against dust.

2.2.2.4.
The requirement of paragraph 2.2.1.3 shall apply with respect to its safe opening of pieces of equipment.

2.3.
Requirements for equipment group II, category 3

2.3.1.
Explosive atmosphere formed by gases, vapors or mists

2.3.1.1.
Equipment must be designed and manufactured so that ignition sources that can be predicted to occur under normal use does not occur.

2.3.1.2.
The surface temperature should under normal operating conditions must not exceed the specified maximum surface temperature. Overruns in special cases can be accepted only if the manufacturer hit specific supplemental protective measures.

2.3.2.
Explosive atmosphere caused by the presence of dust-air mixtures

2.3.2.1.
Equipment must be designed and manufactured so that ignition sources which can be expected to occur under normal operating conditions can ignite the dust-air mixtures.

2.3.2.2.
For surface temperature, the requirements of paragraph 2.1.2.3.

2.3.2.3.
Equipment, including cable entries and transition pieces shall be designed to be taken into account støvpartiklenes size so that the formation of explosive dust-air mixtures and hazardous dust deposits are avoided.

3. Additional requirements for security

3.0.
General requirements

3.0.1.
Security should be designed so that the effects of an explosion brought down to an acceptable level of safety.

3.0.2.
Security must be designed and could be placed so that it is prevented that an explosion propagates through dangerous chain reactions or flare-ups, and that incipient explosions become detonations.

3.0.3.
Security shall, if energy supply is interrupted, be able to preserve the functioning of such a long time that there is no hazard.

3.0.4.
Security should not display malfunction when exposed to interference from outside.

3.1.
Planning and design

3.1.1.
Material Properties of

The maximum pressure and temperature to be taken into account at the planning stage with regard to the properties of materials shall be the expected pressure during an explosion caused by extreme operating conditions and the anticipated heating influences.

3.1.2.
Security system that is designed to enable them to resist or limit an explosion, to withstand the pressure wave from an explosion, and the system is damaged.

3.1.3.
Accessories connected to protective systems must be capable of withstanding the expected maximum explosion pressure and still work.

3.1.4.
When planning and design of protective systems must be taken of any reaction by the pressure in the external equipment and fittings thereto by an explosion.

3.1.5.
Pressure Relief Devices

Security as by an explosion believed to be exposed to influences that are stronger than they can bear, shall be equipped with suitable pressure relief devices which do not cause danger to people nearby.

3.1.6.
System Embossing of explosions

System Embossing of explosions must be planned and designed that they react as early as possible after an initial explosion and prevents the optimum, taking into account the maximum pressure rise rate and maximum explosion pressure.

3.1.7.
Eksplosjonsutkoplingssystem

Utkoplingssystem as by incipient explosion is intended to disengage the special equipment as quickly as possible by means of suitable devices, will be designed and constructed so that the fire can not spread in the system and maintains its mechanical strength under normal operating conditions.

3.1.8.
Protective systems must be so connected, and have a low alarm threshold, the supply and discharge of products processed stopped and that the pieces of equipment that no longer works safely be stopped or switched off, if required.

Appendix III. Module B: EC type examination

1.
EC type examination is the part of the conformity assessment procedure whereby a notified body examines a product's technical design and that verifies the product's technical design meets the requirements of this Directive which apply to it.

2.
EC type examination shall include examination of a copy of the complete product that is representative of the planned production (production type).

3.

The manufacturer shall submit an application for EU-type examination with a single notified body of his choice.

The application shall include:

A)
manufacturer's name and address and the authorized representative's name and address if the application is submitted by the representative,

B)
a written declaration that the same application has not been submitted to another notified body,

C)
the technical documentation. The technical documentation shall make it possible to assess whether the product complies with the applicable requirements of this regulation and shall include an adequate analysis and assessment of risk. The technical documentation shall specify the applicable requirements and shall, to the extent relevant for such assessment, cover product design, production and operation. The technical documentation shall contain at least the following elements:

I)
a general description of the product,

Ii)
design and manufacturing drawings, component lists, lists of sub-assemblies, circuit diagrams etc.,

Iii)
descriptions and explanations necessary to understand the drawings and lists and how the product works,

Iv)
a list of the harmonized standards which are wholly or partially used, as it is published references in the Official Journal, and if the harmonized standards have not been applied, descriptions of the solutions adopted for to meet the basic health and safety requirements of these regulations, including a list of other relevant technical specifications applied. If harmonized standards partially applied, the technical documentation shall specify the parts which have been applied,

V)
results of design calculations, examinations carried out, etc., And

Vi)
test reports,

D)
specimens representative of the production envisaged. The notified body may request further examples if needed for carrying out the test program.

4.
The notified body shall

4.1
examine the technical documentation, verify that your copy or copies have been produced in accordance with the technical documentation, and identify elements that are constructed according to the applicable provisions of the relevant harmonized standards, as well as items that are constructed according to other relevant technical specifications || |
4.2
perform or cause to be performed the appropriate examinations and tests to check whether the solutions in the relevant harmonized standards have been applied correctly, where the manufacturer has chosen to apply,

4.3
perform or cause to be performed the appropriate examinations and tests to check whether the solutions adopted by the manufacturer, including solutions in other relevant technical specifications applied, meets the basic health and safety requirements of this regulation, in cases where the solutions in the relevant harmonized standards are not used,

4.4
consultation with the manufacturer where the examinations and tests will be carried.

5.
The notified body shall draw up an assessment report describing the activities carried out pursuant to paragraph. 4, and the results thereof. Without prejudice to its obligations to the Directorate for Civil Protection and Emergency Planning, the notified body make public all or part of the contents of the report only with the manufacturer's consent.

6.
Where the type meets the requirements of this Directive which apply the affected product, the notified body must issue an EC type examination certificate to the manufacturer. The certificate must contain the name and address of the manufacturer, conclusions of the examination, any conditions for its validity and the information required to identify the approved type. EC type examination certificate may have one or more attachments.

EC type examination certificate and its annexes shall contain all information which is relevant to assess whether the products are in accordance with the examined type and to control the products in use.
If type does not satisfy the applicable requirements of these Regulations, the notified body may refuse to issue an EC type examination certificate and shall inform the applicant and provide the applicant with detailed reasons for the rejection.

7.
The notified body shall keep itself apprised of any changes in the generally recognized technological developments which indicate that the approved type no longer meets the applicable requirements of this Regulation and determine whether such changes require further investigation. In this case, the notified body shall inform the manufacturer thereof.


The manufacturer must inform the notified body that holds the technical documentation for EU-type examination certificate of all modifications to the approved type that may affect the product complies with the essential health and safety requirements of these regulations or the conditions of validity the certificate. Such changes require additional approval in the form of an addition to the original EC type examination certificate.

8.
Each notified body shall inform the Directorate for Civil Protection and Emergency Planning, EC type examination certificates and / or any addition to those it has issued or withdrawn, and shall, periodically or upon request, make available to the Directorate for Civil Protection and Emergency Planning list of such certificates and / or supplements to those who are refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies the EC-type examination certificates and / or any addition to those it has refused, withdrawn, suspended or otherwise restricted, and, upon request, notify such certificates and / or additions to them it has issued.
Commission, the authorities of the EEA and the other notified bodies may receive on request a copy of the EC type examination certificates and / or additions to them. On request, the Commission and the authorities of the EEA obtain a copy of the technical documentation and the results of surveys conducted by the notified body. The notified body shall keep a copy of the EC type examination certificate, its annexes and additions, as well as the technical documentation, including documentation that the manufacturer has submitted, until the expiry of its validity period.

9.
The manufacturer shall keep a copy of the EC type examination certificate with annexes and additions together with the technical documentation for ten years after the product was put on the market so that these documents can be made available to supervisory authorities.

10.
Manufacturer's authorized representative may submit the application referred to in Nos. 3 and fulfill the obligations set out in paragraph. 7 and 9, provided that they are specified in the authorization.

Annex IV. Module D: Conformity to type based on quality assurance of the production process

1.
Conformity to type based on quality assurance of the production process is the part of the conformity assessment procedure whereby the manufacturer fulfills the obligations laid down in Nos. 2 and 5, and ensures and declares in sole responsibility that the products concerned are in conformity with the type described in the EC type examination certificate and satisfies the applicable requirements in this regulation.

2.
production

The manufacturer must operate an approved quality system for production, inspection of finished products and testing of the products concerned as described in paragraph. 3. The manufacturer shall be subject to controls referred to in paragraph 4.

3.
quality

3.1
The manufacturer shall submit an application for assessment of his quality system for the products concerned with a notified body of his choice.

The application shall include:

A)
manufacturer's name and address and the authorized representative's name and address if the application is submitted by the representative,

B)
a written declaration that the same application has not been lodged with another notified body,

C)
all information relevant to the planned product category,

D)
documentation for quality system

E)
the technical documentation for the approved type and a copy of the EC type examination certificate.

3.2
The quality system must ensure that the products conform to the type described in the EC type examination certificate and with the applicable requirements of this regulation.

All the elements, requirements and provisions adopted by the manufacturer into account, must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This documentation for the quality system must ensure a clear understanding of the quality programs, plans, manuals and records.
Must include in particular an adequate description of

A)
quality objectives and the organizational structure, responsibilities and powers with regard to product quality,

B)
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

C)
examinations and tests that will be carried out before, during and after manufacture, and information about how often they will be executed,

D)
quality records, such as inspection reports and test data, calibration data, reports on the personnel concerned qualifications etc., And

E)

Methods to monitor that the required product quality is achieved, and that the quality system is working effectively.

3.3
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph. 3.2.

It shall presume that the quality system meets the requirements with regard to the elements of the quality system complies with the corresponding specifications of the relevant harmonized standard.
In addition to having experience in quality management systems, at least one of the audit team members have experience in assessing the relevant product area and the affected product technology, and have knowledge of the applicable requirements of this regulation. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in paragraph. 3.1 letter e to verify the manufacturer's ability to identify the relevant requirements of these regulations and to undertake the necessary investigations with a view to ensure that the product complies with the requirements.
The manufacturer shall be notified of the decision. The notification must contain the conclusions of the audit and the reasoned decision.

3.4
The manufacturer must undertake to fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the amended quality system will continue to satisfy the requirements referred to in paragraph. 3.2 or whether a reassessment is required assessment.
It shall notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the reasoned decision.

4.
Control of the notified body responsible

4.1
The purpose of the audit is to ensure that the manufacturer duly fulfills the obligations arising out of the approved quality system.

4.2
The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage and provide it with all necessary information, in particular

A)
documentation quality system

B)
quality records, such as inspection reports and test data, calibration data, reports on the personnel concerned qualifications etc.

4.3
The notified body shall conduct periodic audits to ensure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4.4
The notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out or cause to be performed product tests to verify that the quality system is working satisfactorily. The notified body shall provide the manufacturer with a visit report and a test report if it were to be carried out tests.

5.
CE marking, declaration of conformity and compliance certificate

5.1
The manufacturer shall affix the CE marking, and, under the responsibility of the notified body referred to in paragraph. 3.1, the latter's identification number to each individual product that is not a component and which is consistent with the type described in the EC type examination certificate and satisfy the applicable requirements of this Regulations.

5.2
The manufacturer shall draw up a written declaration of conformity for each product model, which is not a component, and to set it at the disposal of the supervisory authorities for ten years after the product which is not a component were placed on the market. The declaration of conformity shall identify the product model it has been drawn.

A copy of the Declaration to accompany each product that is not a component.

5.3
The manufacturer shall draw up a written declaration certificate for each component model and could set it at the disposal of the supervisory authorities for ten years after the component was put into circulation. Conformity certificate shall specify the component model it has been drawn. A copy of the certificate must accompany each component.

6.
The manufacturer shall, for a period of ten years after the product was put into circulation could present to the supervisory authorities

A)
documentation referred to in paragraph. 3.1

B)
information about approved amendments referred to in paragraph. 3.5,

C)
decisions and reports from the notified body referred to in paragraph. 3.5, 4.3 and 4.4.

7.

Each notified body shall inform the Directorate for Civil Protection and Emergency Planning on the quality system approvals which it has issued or withdrawn, and shall, periodically or upon request, make available to the Directorate for Civil Protection and Emergency Planning list of quality system approvals which are refused, suspended or otherwise limited.

Each notified body shall inform the other notified bodies the quality system approvals it has refused, suspended, withdrawn or otherwise restricted, and, upon request, inform about the quality system approvals it has issued.

8.
Authorized Representative

Manufacturer obligations specified in paragraph. 3.1, 3.5, 5 and 6 may be fulfilled by their authorized representative, on his behalf and responsibility, provided that they are specified in the authorization.

Annex V. Module F: Conformity to type based on product verification

1.
Conformity to type based on product verification is the part of the conformity assessment procedure whereby the manufacturer fulfills the obligations laid down in Nos. 2 and 5, and ensures and declares in sole responsibility that the products concerned, which have been covered by the provisions of no. 3, is in conformity with the type described in the EC type examination certificate and satisfies the applicable requirements of this regulation.

2.
production

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring this ensures that the manufactured products conform to the approved type described in the EC type examination certificate and with the applicable requirements of this regulation.

3.
verification

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to verify whether products conform to the approved type described in the EC type examination certificate and with the applicable requirements of this regulation.
Examinations and tests to check whether the products are in compliance with the applicable requirements, shall be carried out by examination and testing of every product as specified in paragraph 4.

4.
Verification of compliance based on examination and testing of every product

4.1
All products are examined individually and the appropriate tests, as defined in the relevant harmonized standards or other relevant technical specifications shall be performed to verify that the products conform to the approved type described in the EC type examination certificate and with requirements of this regulation.

In the absence of such a harmonized standard shall be notified body concerned determine the appropriate tests to be performed.

4.2
The notified body shall issue a certificate of conformity on the basis of the performed tests and trials, and shall affix its identification number to each approved product or have it applied to their responsibilities.

Manufacturer shall keep the certificates of conformity and shall be made available to the supervisory authorities for control for ten years after the product is placed on the market.

5.
CE marking, declaration of conformity and compliance certificate

5.1
The manufacturer shall affix the CE marking, and, under the responsibility of the notified body referred to in paragraph. 3, the latter's identification number to each individual product that is not a component which is in conformity with the approved type described in the EC type examination certificate and satisfy the applicable requirements in this regulation.

5.2
The manufacturer shall draw up a written declaration of conformity for each product model, which is not a component, and to set it at the disposal of the supervisory authorities for ten years after the product which is not a component, was placed on the market. The declaration of conformity shall identify the product model it has been drawn.

A copy of the Declaration to accompany each product that is not a component.
If the notified body referred to in paragraph. 3 agrees to it, the manufacturer may also, under its responsibility, affix its identification number to the products that are not components.

5.3
The manufacturer shall draw up a written declaration certificate for each component model and could set it at the disposal of the supervisory authorities for ten years after the component was put into circulation. Conformity certificate shall specify the component model it has been drawn. A copy of the certificate must accompany each component.

6.
If the notified body agrees, the manufacturer may also, under its responsibility, affix the notified body's identification number to the products during the manufacturing process.

7.
Authorized Representative


Manufacturer obligations can be met by their authorized representative, on his behalf and responsibility, provided that they are specified in the authorization. An authorized representative may not fulfill the manufacturer's obligations under paragraph. 2.

Annex VI. Module C1: Conformity to type based on internal production control plus supervised product testing

1.
Conformity to type based on internal production control plus supervised product testing is the part of the conformity assessment procedure whereby the manufacturer fulfills the obligations laid down in no. 2, 3 and 4, and ensures and declares in sole responsibility that the products concerned are in conformity with the type described in the EC type examination certificate and meets the applicable requirements of the regulations.

2.
production

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure that the manufactured products conform with the type described in the EC type examination certificate and with the applicable requirements of the regulations.

3.
Product Make

For each product produced, the manufacturer or someone on his behalf to perform one or more tests on one or more product characteristics to verify that products conform with the type described in the EC type examination certificate and with the corresponding requirements of the Directive. The tests shall be performed under the responsibility of a notified body chosen by the manufacturer.
The manufacturer shall, under the notified body's responsibility, affix the notified body's identification number in the production process.

4.
CE marking, declaration of conformity and compliance certificate

4.1
The manufacturer shall affix the CE marking on each product which is not a component, and that is consistent with the type described in the EC type examination certificate and satisfies the applicable requirements of the regulations.

4.2
The manufacturer shall draw up a written declaration of conformity for a product model which is not a component, and to set it at the disposal of the supervisory authorities for ten years after the product, which is not a component, was placed on the market. The declaration of conformity shall identify the product model it has been drawn.

A copy of the Declaration to accompany each product that is not a component.

4.3
The manufacturer shall draw up a written declaration certificate for each component model and could set it at the disposal of the supervisory authorities for ten years after the component was put into circulation. Conformity certificate shall specify the component model it has been drawn. A copy of the certificate must accompany each component.

5.
Authorized Representative

Manufacturer obligations specified in paragraph. 4 can be met by their authorized representative, on his behalf and responsibility, provided that they are specified in the authorization.

Annex VII. Module E: Conformity to type based on quality assurance of products

1.
Conformity to type based on product quality assurance is that part of the conformity assessment procedure whereby the manufacturer fulfills the obligations laid down in Nos. 2 and 5, and ensures and declares in sole responsibility that the products concerned are in conformity with the type described in the EC type examination certificate and satisfies the applicable requirements of Regulations.

2.
production

The manufacturer must operate an approved quality system as specified in paragraph. 3 for inspection and testing of finished products and shall be subject to controls referred to in paragraph 4.

3.
quality

3.1
The manufacturer shall submit an application for assessment of his quality system for the products concerned with a notified body of his choice.

The application shall include:

A)
manufacturer's name and address and the authorized representative's name and address if the application is submitted by the representative,

B)
a written declaration that the same application has not been submitted to another notified body,

C)
all information relevant to the planned product category,

D)
documentation for quality system and

E)
the technical documentation for the approved type and a copy of the EC type examination certificate.

3.2
The quality system must ensure that the products conform to the type described in the EC type examination certificate and with the applicable requirements of the regulations.

All the elements, requirements and provisions adopted by the manufacturer into account, must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This documentation for the quality system must ensure a clear understanding of the quality programs, plans, manuals and records.
Must include in particular an adequate description of

A)
quality objectives and the organizational structure, responsibilities and powers with regard to product quality,

B)

Examinations and tests that will be carried out after manufacture,

C)
quality records, such as inspection reports and test data, calibration data, reports on the personnel concerned qualifications etc.,

D)
methods to verify that the quality system is working effectively.

3.3
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph. 3.2.

It shall presume that the quality system meets the requirements with regard to the elements of the quality system complies with the corresponding specifications of the relevant harmonized standard.
In addition to having experience in quality management systems, at least one of the audit team members have experience in assessing the relevant product area and the affected product technology, and have knowledge of the applicable requirements of the regulations. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in paragraph. 3.1 letter e to verify the manufacturer's ability to identify the relevant requirements of the regulations and to undertake the necessary investigations with a view to ensure that the product complies with the requirements.
The manufacturer shall be notified of the decision. The notification must contain the conclusions of the audit and the reasoned decision.

3.4
The manufacturer must undertake to fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the amended quality system will continue to satisfy the requirements referred to in paragraph. 3.2 or whether a reassessment is required assessment.
The manufacturer shall be notified of the decision. The notification must contain the conclusions of the examination and the reasoned decision.

4.
Control of the notified body responsible

4.1
The purpose of monitoring is to ensure that the manufacturer duly fulfills the obligations arising out of the approved quality system.

4.2
The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage and provide it with all necessary information, in particular

A)
documentation quality system

B)
quality records, such as inspection reports and test data, calibration data, reports on the personnel concerned qualifications etc.

4.3
The notified body shall conduct periodic audits to ensure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4.4
The notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out or cause to be performed product tests to verify that the quality system is working satisfactorily. The notified body shall provide the manufacturer with a visit report and a test report if it were to be carried out tests.

5.
CE marking, declaration of conformity and compliance certificate

5.1.
The manufacturer shall affix the CE marking, and, under the responsibility of the notified body referred to in paragraph. 3.1, the latter's identification number to each individual product that is not a component and which is consistent with the type described in the EC type examination certificate and satisfy the applicable requirements of Regulation .

5.2
The manufacturer shall draw up a written declaration of conformity for each product model, which is not a component, and to set it at the disposal of the supervisory authorities for ten years after the product which is not a component were placed on the market. The declaration of conformity shall identify the product model it has been drawn.

A copy of the Declaration to accompany each product that is not a component.

5.3
The manufacturer shall draw up a written declaration certificate for each component model and could set it at the disposal of the supervisory authorities for ten years after the component was put into circulation. Conformity certificate shall specify the component model it has been drawn. A copy of the certificate must accompany each component.

6.
The manufacturer shall, for a period of ten years after the product was put into circulation could submit to the regulatory authorities in

A)
documentation referred to in paragraph. 3.1

B)
information about approved amendments referred to in paragraph. 3.5,

C)
decisions and reports from the notified body referred to in paragraph. 3.5, 4.3 and 4.4.

7.

Each notified body shall inform the Directorate for Civil Protection and Emergency Planning on the quality system approvals which it has issued or withdrawn, and shall, periodically or upon request, make available to the Directorate for Civil Protection and Emergency Planning list of quality system approvals which are refused, suspended or otherwise limited.

Each notified body shall inform the other notified bodies the quality system approvals it has refused, suspended or withdrawn, and, upon request, inform about the quality system approvals it has issued.

8.
Authorized Representative

Manufacturer obligations specified in paragraph. 3.1, 3.5, 5 and 6 may be fulfilled by their authorized representative, on his behalf and responsibility, provided that they are specified in the authorization.

Annex VIII. Module A: Internal production control

1.
Internal production control is the conformity assessment procedure whereby the manufacturer fulfills the obligations laid down in no. 2, 3 and 4, and ensures and declares in sole responsibility that the products concerned meet the applicable requirements of the regulations.

2.
Technical documentation

Manufacturer shall establish the technical documentation. The documentation shall make it possible to assess whether the product complies with the relevant requirements, and shall include an adequate analysis and assessment of risk.
The technical documentation shall specify the applicable requirements and shall, to the extent relevant for such assessment, cover product design, production and operation. The technical documentation shall contain at least the following elements:

A)
a general description of the product,

B)
design and manufacturing drawings, component lists, lists of sub-assemblies, circuit diagrams etc.,

C)
descriptions and explanations necessary to understand the drawings and lists and how the product works,

D)
a list of the harmonized standards which are wholly or partially used, as it is published references in the Official Journal, and if the harmonized standards have not been applied, descriptions of the solutions adopted for to meet the basic health and safety regulations, including a list of other relevant technical specifications applied. If harmonized standards partially applied, the technical documentation shall specify the parts which have been applied,

E)
results of design calculations, examinations carried out, etc., And

F)
test reports.

3.
production

The manufacturer shall take all necessary measures for the manufacturing process and its monitoring this ensures that the manufactured products are in conformity with the technical documentation referred to in Nos. 2 and meets the applicable requirements of the regulations.

4.
CE marking, declaration of conformity and compliance certificate

4.1
The manufacturer shall affix the CE marking on each product which is not a component, and that meets the applicable requirements of the regulations.

4.2
The manufacturer shall draw up a written declaration of conformity for a product model which is not a component, and to set it and the technical documentation at the disposal of the supervisory authorities for ten years after the product which is not a component, was placed on the market. The declaration of conformity shall identify the product model it has been drawn.

A copy of the Declaration to accompany each product that is not a component.

4.3
The manufacturer shall draw up a written declaration certificate for each component model and be able to make it and the technical documentation at the disposal of the supervisory authorities for ten years after the component was put into circulation. Conformity certificate shall specify which component it has been drawn. A copy of the certificate must accompany each component.

5.
Authorized Representative

Manufacturer obligations specified in paragraph. 4 can be met by their authorized representative, on his behalf and responsibility, provided that they are specified in the authorization.

Annex IX. Module G: Conformity based on unit verification

1.
Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfills the obligations laid down in no. 2, 3 and 5, and ensures and declares in sole responsibility that the affected product, which has been covered by the provisions of no. 4, is in conformity with the applicable requirements of the regulations.

2.
Technical documentation

2.1

The manufacturer shall establish the technical documentation and set it at the disposal of the notified body referred to in paragraph 4. The documentation shall make it possible to assess whether the product complies with the relevant requirements, and shall include an adequate analysis and assessment of risk. The technical documentation shall specify the applicable requirements and shall, to the extent relevant for such assessment, cover product design, production and operation. The technical documentation shall contain at least the following elements:

A)
a general description of the product,

B)
design and manufacturing drawings, component lists, lists of sub-assemblies, circuit diagrams etc.,

C)
descriptions and explanations necessary to understand the drawings and lists and how the product works,

D)
a list of the harmonized standards which are wholly or partially used, as it is published references in the Official Journal, and if the harmonized standards have not been applied, descriptions of the solutions adopted for to meet the basic health and safety regulations, including a list of other relevant technical specifications applied. If harmonized standards partially applied, the technical documentation shall specify the parts which have been applied,

E)
results of design calculations, examinations carried out, etc., And

F)
test reports.

2.2
The manufacturer shall keep the technical documentation and be able to make it available to the supervisory authorities for ten years after the product is placed on the market.

3.
production

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring this ensures that the manufactured product complies with the applicable requirements of the regulations.

4.
verification

A notified body chosen by the manufacturer must perform or cause to be performed appropriate examinations and tests, as provided in the relevant harmonized standards and / or equivalent tests laid down in other relevant technical specifications to ensure that the products comply with the applicable requirements of Regulations. In the absence of such a harmonized standard shall be notified body concerned determine the appropriate tests to be performed.
The notified body shall issue a certificate of conformity on the basis of the performed tests and trials, and shall affix its identification number on the approved product or have it applied to their responsibilities.
Manufacturer shall keep the certificates of conformity and shall be made available to the supervisory authorities for ten years after the product is placed on the market.

5.
CE marking, declaration of conformity and compliance certificate

5.1
The manufacturer shall affix the CE marking, and, under the responsibility of the notified body referred to in paragraph. 4, the latter's identification number to each product that is not a component, and that complies with applicable requirements of the regulations.

5.2
The manufacturer shall draw up a declaration of conformity and to set it at the disposal of the supervisory authorities for ten years after the product which is not a component, was placed on the market. The Declaration shall specify which product it is designed.

A copy of the Declaration to accompany each product that is not a component.

5.3
The manufacturer shall draw up a written declaration certificate and be able to make it available to the supervisory authorities for ten years after the component was put into circulation. Conformity certificate shall specify which component it has been drawn. A copy of the certificate must accompany each component.

6.
Authorized Representative

Manufacturer obligations specified in paragraph. 2.2 and 5 can be met by their authorized representative, on his behalf and responsibility, provided that they are specified in the authorization.

Annex X.

A.
CE marking

The CE conformity marking shall consist of the initials CE taking the following form:

If the CE marking is reduced or enlarged, the proportions stated in the above drawing is held.
The various components of the CE marking consists shall have substantially the same height and not be less than 5 mm.
Minimum dimension may be waived for equipment and safety etc. of small size.

B.
EC declaration of conformity

EC declaration of conformity shall include the following elements:

-
Name and address of the manufacturer or his authorized representative in the EEA,

-
Description of equipment and safety etc.,

-
Provisions that equipment and safety etc. meets,

-
The name, identification number and address of the notified body and number of EC type examination certificate

-

Any reference to the harmonized standards,

-
Possibly the standards and technical specifications used,

-
Identification of the person authorized to enter into commitments on behalf of the manufacturer or his authorized representative in the EEA.