Machine Translation of "RS 734.6 Order of 2 March 1998 on apparatus and protection systems for use in explosive atmospheres (OSPEX)" (Switzerland)

Art. 1 Scope of application

¹ This order applies to appliances and protection systems and to ancillary devices intended for use in explosive atmospheres.

² It does not apply to items listed in s. 1, c. 4 of Directive EC 94/9 of 23 March 1994 on the approximation of the laws of the Member States for apparatus and protection systems for use in explosive atmospheres (Directive) ¹.

¹ JOCE n ^O L 100 of 19.4.1994, p. 1, corrected by JOCE n ^O L 257 of 10.10.96, p. 44. The text of the directive is obtained from the Swiss Standards Association, Bürglistr. 29, 8400 Winterthur (www.snv.ch).

Art. 2 Definitions

For the purposes of this order,

A.: Devices: Machinery, equipment, fixed or mobile devices, control bodies, instrumentation and detection and prevention systems which, alone or in combination, are intended for the production, transport, storage, measurement, The regulation or conversion of energy and the transformation of materials and which, by the potential sources of ignition which are their own, are likely to cause an explosion;
B.: Protection systems: Devices other than the components of the apparatus defined above, the function of which is to immediately stop the nascent explosions or to limit the area affected and which are placed on the market as autonomous function systems;
C.: Accessory devices: Safety, control and adjustment devices which, without being used in explosive atmospheres, are necessary or useful for the safe operation of protective equipment or systems;
D.: Components: Parts that are essential for the safe operation of protective devices and systems but do not have a stand-alone function;
E.: Explosive atmosphere: The mixing, under atmospheric conditions, of air with flammable substances in the form of gases, vapours, fog or dust in which, after ignition, the combustion is propagated to the whole unburned mixture;
F.: Explosive atmosphere: An atmosphere likely to become explosive as a result of local or operational conditions;
G.: Compliant use: The use of apparatus, protection systems and ancillary devices corresponding to the groups and categories of devices defined in Annex 1 and to the indications provided by the manufacturer and whose compliance Safe operation of devices.

Art. 3 Placon the market

¹ "Placing on the market" means the transfer or remission, for pecuniary or non-pecuniary nature, of apparatus, protection systems and ancillary devices intended to be marketed or used in Switzerland.

² The placing in service of appliances, protection systems and accessories for professional purposes in the undertaking shall be regarded as placing on the market, if it has not already taken place in accordance with para. 1.

³ ... ¹

¹ Repealed by c. I 2 of the O of 11 June 2010 adapting sectoral ordinances in the field of product safety, with effect from 1 ^Er Jul. 2010 ( RO 2010 2749 ).

Art. 4 Security

Devices, protection systems and accessories installed and maintained in an appropriate manner shall not endanger persons or things in the event of conformity.

Art. 5 Basic Requirements

Devices, protection systems and accessories may be placed on the market only if they meet the basic requirements set out in Annex II to the Directive.

Art. 6 Technical Standards

¹ The Federal Office for Energy (Office) designates, with the agreement of the Federal Office for External Economic Affairs, the appropriate technical standards to achieve the basic requirements.

² As far as possible, it adopts harmonised international standards.

³ The Office may appoint independent Swiss standards bodies to prepare technical standards.

⁴ The designated technical standards are published in the Federal Worksheet with titles and references ¹.

¹ Lists of the titles of the designated standards and their texts are obtained from the Swiss Standards Association, Bürglistr. 29, 8400 Winterthur (www.snv.ch).

Art. 7 Declaration of Conformity

¹ A person placing on the market a device, a protection system or an ancillary device must be able to submit a declaration of conformity from where it appears that the product meets the basic requirements and that the procedures Conformity assessment prescribed in s. 10 were conducted.

² If the device, protection system or accessory device is subject to a number of regulations requiring a declaration of conformity, a single declaration is sufficient.

³ Written in one of the official languages of Switzerland or in English, the declaration of conformity includes, in particular:

A.: The name or abbreviation and address of the manufacturer or his representative established in Switzerland;
B.: A description of the device, protection system or ancillary device;
C.: Technical requirements and standards or other applied specifications;
D.: Where applicable, the name and address of the test and certification body under s. 11;
E.: The name and address of the person who signs the declaration of conformity for the manufacturer or for his representative established in Switzerland.

⁴ For components according to Art. 2, let. D, it is sufficient for a written attestation from the manufacturer. It must show that the components comply with the requirements of this order. It shall also indicate the characteristics of the components as well as the conditions of incorporation into a device, a protection system or an accessory device which contribute to the fulfilment of the basic requirements.

⁵ The declaration of conformity or the manufacturer's certificate must be capable of being presented for ten years from the production of the device, the protection system or the accessory device. In the case of production in series, the short period from the production of the last copy.

Art. 8 Compliance with requirements

¹ Apparatuses, protection systems and accessories manufactured in accordance with the technical standards referred to in Art. 6 are deemed to meet the basic requirements.

² If these standards are only partially or not applied at all, the person placing on the market devices, protection systems or ancillary devices must be able to demonstrate that they meet the requirements in a different manner Basic.

³ A person who puts on the market must be able to submit a technical dossier enabling the implementing body (Art. 14) to ensure that the basic requirements are met.

Art. Technical folder

¹ Written in one of the official languages of Switzerland or in English, the technical file must provide the following information:

A.: A general description of the device, protection system or ancillary device;
B.: The indication of the measures ensuring the conformity of the device, of the protection system or device ancillary to the basic requirements referred to in Art. 5;
C.: The parts necessary for the conformity assessment procedure according to Art. 10.

² The technical file may be in another language if the information provided for its assessment is given in one of the official languages of Switzerland or in English.

³ The technical file must be capable of being presented for ten years from the production of appliances, protection systems and accessories. In the case of production in series, the short period from the production of the last copy.

Art. 10 Conformity Assessment Procedure

¹ For devices of categories M1 and 1 as well as for protection systems, the "Type Examination" procedure (Annex 2) will be conducted in conjunction with the "Quality Production Insurance" procedure (Annex 3) or with the procedure " Verification on Product " (Annex 4).

² For internal combustion engines and for electrical appliances of categories M2 and 2, the "Type test" procedure (Annex 2) will be conducted in conjunction with the "Conformity to type" procedure (Annex 5) or with the "Quality Assurance" procedure. Product " (Annex 6).

³ For the other categories M2 and 2, the "Internal Manufacturing Control" procedure (Annex 7) shall be conducted and the necessary parts shall be assigned to a body under Article 11 for storage.

⁴ For Category 3 devices, the "Internal Manufacturing Control" procedure (Annex 7) will be conducted.

⁵ Instead of procedures according to paras. 1 to 4, one can in all cases conduct the procedure "Verification of the unit" (Annex 8).

⁶ If accessory devices are to be put into the trade at the same time as a device, the procedures prescribed in paras. 1 to 5 will be conducted jointly for the device and the accessory devices.

⁷ The prescribed procedures for each device category apply by analogy to the components.

⁸ For safety aspects in accordance with Annex II, c. 1.2.7 of the Directive, it is possible in all cases to also conduct the "Internal manufacturing control" procedure (Annex 7).

⁹ Where this is justified, the implementing body may authorise the placing on the market or the placing in service of apparatus, protection systems and ancillary devices without the procedures provided for here have been conducted.

Art. 11 Test and attestation of conformity bodies

¹ The testing and certification bodies that issue reports or certifications under s. 10 must:

A.: Be accredited in accordance with the order of 17 June 1996 on accreditation and designation ¹;
B.: Be recognized in Switzerland under international agreements, or
C.: Be authorized in any other way by Swiss law.

² The person who refers to a file emanating from a body other than those referred to in para. 1 must show credibly that the methods and powers of the said body comply with the Swiss requirements (Art. 18, para. 2, LETC).

¹ RS 946.512

Art. 12

¹ Used appliances, protection systems and accessories can only be placed on the market if they comply with the requirements in force at the time of their first placing on the market.

² Devices, protection systems and ancillary devices for which certain important safety organs have been transformed or renewed shall be subject to the provisions governing the placing on the market of equipment New.

Art. 13

Devices, protection systems and accessories which do not meet the requirements of the placing on the market may be exposed or presented if the following conditions are met:

A.: It is clearly stated that the said devices do not enjoy a certificate that they meet the legal requirements, and that they cannot therefore be placed on the market; and
B.: Measures to protect people and things have been taken.

Art. 14 Principle

¹ The implementing body shall ensure that devices, protection systems and ancillary devices placed on the market correspond to the requirements of this order. For this purpose, it performs a number of points and examines the evidence that a product does not meet the requirements.

² The following are implementing bodies:

A.: The implementing body according to Art. 21 LIE for appliances, protective systems and accessories for electric ignition and for electrical installations placed in zones with explosive atmospheres;
B. ¹: The implementing bodies within the meaning of Art. 20 of the order of 19 May 2010 on product safety (OSPro) ² For other devices, protection systems and accessories.

³ The enforcement agencies may request the Customs Administration to provide, for a specified period of time, information on imports of well-defined equipment, protection systems and ancillary devices.

¹ New content according to the c. II 2 of Annex 4 to the O of 19 May 2010 on product safety, in force since 1 ^Er Jul. 2010 ( RO 2010 2583 ).
² RS 930.111

Art. 15 Powers of implementing bodies

¹ The implementing body shall be entitled, in the context of market surveillance, to require the documents and information necessary to prove the conformity of apparatus, protection systems and ancillary devices, to be taken from Samples and audits; they may enter the company's premises during normal working hours. ¹

² If the person responsible for placing on the market fails to provide all or part of the documents requested within the time limit fixed by the implementing body, the latter may order an audit. The cost is borne by the person responsible for placing on the market.

³ The implementing body may also order an audit where

A.: It is not clear enough from the declaration of conformity under s. 7 that equipment, protection systems and ancillary devices meet the requirements;
B.: A device, a protection system or an ancillary device may not correspond to the file submitted.

⁴ If the verification under para. 3 shows that devices, protection systems or ancillary devices do not meet the requirements, the cost is borne by the person who has placed on the market.

⁵ Before ordering the verification, the implementing body shall give the person responsible for marketing the opportunity to speak. A device, a protection system or an ancillary device chosen by the implementing body shall be made available free of charge for the verification.

¹ New content according to the c. I 2 of the O of 11 June 2010 adapting sectoral ordinances in the field of product safety, in force since 1 ^Er Jul. 2010 ( RO 2010 2749 ).

Art. 16 Measures

¹ If the control or verification reveals that the provisions of this order have been violated, the implementing body shall order measures in accordance with Art. 10, para. 2-5, LSPro. ¹

² ... ²

³ In accordance with the provisions of the Regulation of the applicable fees, the implementing bodies charge a fee and charge the persons concerned for:

A.: Checks as to whether the product does not meet the requirements;
B.: Decisions taken under the control of equipment and protection systems for use in explosive atmospheres. ³

⁴ The implementing body shall be competent to grant international administrative assistance under art. 22 LATVIAN.

¹ New content according to the c. I 2 of the O of 11 June 2010 adapting sectoral ordinances in the field of product safety, in force since 1 ^Er Jul. 2010 ( RO 2010 2749 ).
² Repealed by c. I 2 of the O of 11 June 2010 adapting sectoral ordinances in the field of product safety, with effect from 1 ^Er Jul. 2010 ( RO 2010 2749 ).
³ New content according to the c. 4 of the appendix to the O of 9 Oct. 2013, in effect since 1 ^Er Dec. 2013 ( RO 2013 3509 ).

Art. 17 Coordination

¹ ... ¹

² The implementing bodies shall inform each other and inform the Commission of the results of their checks and announce in particular the deficiencies found on equipment, protection systems and ancillary devices.

¹ Repealed by c. II 2 of Annex 4 to the O of 19 May 2010 on product safety, with effect from 1 ^Er Jul. 2010 ( RO 2010 2583 ).

Art. 18 ¹

Appeals against decisions of the implementing bodies referred to in Art. 14, para. 2, are governed, in the case of the let. A, by s. 23 LIE, and in the case of the let. B, art. 15 LSPro.

¹ New content according to the c. II 2 of Annex 4 to the O of 19 May 2010 on product safety, in force since 1 ^Er Jul. 2010 ( RO 2010 2583 ).

Art. 19 Transitional provisions

¹ ... ¹

² If devices, protection systems or accessory devices are verified according to the technical standards of generation A or B, their placing on the market requires the prior approval of the Federal Inspection of Current Installations Strong. Approval shall be given if the test reports of an organ under Article 11 establish the conformity of devices, protection systems or devices ancillary to the basic requirements.

³ If appliances, protection systems or accessory devices are verified according to the technical standards of a recent generation (generation C or better), their placing on the market requires the prior approval of the Federal Inspection of Strong current facilities. Approval shall be given if the test reports, test reports or certificates of conformity of a body according to Art. 11 establish the conformity of devices, protection systems or devices ancillary to the basic requirements.

¹ Repealed by c. IV 26 of the O of 22 August 2007 on the formal updating of the federal law, with effect from 1 ^Er Jan 2008 ( RO 2007 4477 ).

Art. Entry into force

This order shall enter into force on 1 ^Er April 1998.

(art. 2)

Device Groups and Categories

1 Device Group I (M)

1.1 Category M1

The M1 category includes apparatus designed and, if necessary, equipped with additional special protection means to operate in accordance with the operational parameters established by the manufacturer and to ensure a very high level of protection.

The devices in this category are intended for underground workings of mines and parts of their surface installations that are put at risk by gas or combustible dust.

These devices must remain operational even in the event of a rare disturbance in an explosive atmosphere, they are equipped with means of protection such as:

-: In the event of failure of one of the means of protection, the level of security required shall remain ensured by at least one second means of independent protection, or
-: In case of the appearance of two independent defects, the required level of security remains assured.

These devices shall meet the additional requirements referred to in Annex II, figure 2.0.1.

1.2 Category M2

The M2 category includes equipment designed to operate in accordance with the operational parameters established by the manufacturer and ensuring a high level of protection.

The devices in this category are intended for underground workings of mines and parts of their surface facilities that are likely to be endangered by greygish or combustible dust.

If the atmosphere becomes explosive, the power supply of these devices must be able to be cut off.

The means of protection that equip these apparatus shall ensure the level of safety required in normal operation, including in difficult operating conditions, in particular in the case of brutal use of the appliance and in ambient conditions Changing.

These devices shall meet the additional requirements set out in Annex II, c. 2.0.2.

2 Device Group II

2.1 Category 1

Category 1 includes devices designed to operate in accordance with the operational parameters established by the manufacturer and ensure a very high level of protection.

The equipment in this category is intended for an environment in which there is constant, or for a long time, an explosive atmosphere due to the mixing of air with gases, vapours, fog or dust.

These devices must ensure the required level of safety, even in the event of a rare disturbance, they are equipped with means of protection such as:

-: In the event of failure of one of the means of protection, the level of security required shall remain ensured by at least one second means of independent protection, or
-: In case of the appearance of two independent defects, the required level of security remains assured.

Devices in this category must meet the additional requirements set out in Annex II, c. 2.1.

2.2 Category 2

Category 2 includes devices designed to operate in accordance with the operational parameters established by the manufacturer and ensure a high level of protection.

Devices in this category are intended for an environment in which an occasional explosive atmosphere is required due to gases, vapours, fog or the mixing of air and dust.

The means by which these devices are equipped shall ensure the required level of safety, even in the event of frequent disturbances or malfunctions which must normally be taken into account.

These devices shall meet the additional requirements set out in Annex II, c. 2.2.

Category 3

Class 3 includes devices designed to operate in accordance with the operational parameters established by the manufacturer and to ensure a normal level of protection.

Devices in this category are intended for an environment in which an explosive atmosphere is not expected due to gases, vapours, fog, or the mixing of air and dust, and where such an atmosphere, if it occurs, does not Will subsist only briefly.

Devices in this category ensure the level of protection required in the event of normal operation.

These devices shall meet the additional requirements set out in Annex II, c. 2.3.

State 1 ^Er December 2013

(art. 9)

"Type Scan" procedure

1

The 'type examination' shall be the procedure by which a body of attestation of conformity establishes and certifies that a representative copy of the production concerned complies with the corresponding provisions of the Directive.

2

The application for a type examination shall be submitted by the manufacturer (or his representative in Switzerland) to an attestation body of his choice.

The application includes:

-: The name and address of the manufacturer, together with the name and address of the representative if the application is made by the representative;
-: A written declaration that the same application has not been lodged with another attestation body;
-: The technical documentation described in c. 3.

The applicant shall make available to the certifying body a representative copy of the production concerned, hereinafter referred to as "the type". The certifying body may request other copies if required by the testing programme.

3

The technical file must assess whether the product meets the requirements of the Directive. To the extent that this assessment requires it, it must cover the design, manufacture and operation of the product and contain:

-: A general description of the type;
-: Design and manufacturing drawings, as well as component diagrams, subassemblies, circuits, etc.;
-: The descriptions and explanations necessary for the understanding of the said drawings and diagrams and the operation of the product;
-: A list of standards referred to in s. 6, applied in whole or in part, and descriptions of the solutions adopted to meet the essential requirements where these standards have not been applied;
-: Results of design calculations performed, examinations carried out, etc.;
-: Test reports.

4

The certificate of conformity body shall:

4.1

Examines the technical file, verifies that the type has been manufactured in accordance with the technical file, and identifies the elements designed in accordance with the applicable provisions of the standards referred to in s. 6, and those whose design does not rely on those provisions;

4.2

Carries out or causes to be carried out the appropriate tests and tests necessary to verify whether the solutions adopted by the manufacturer satisfy the essential requirements of the Directive where the standards referred to in Art. 6 have not been applied;

4.3

Carries out or causes to be carried out the appropriate checks and tests necessary to verify whether, in the case where the manufacturer has chosen to apply the relevant standards, they have actually been applied;

4.4

Agreement with the applicant on where the necessary controls and tests will be carried out.

5

Where the type complies with the provisions of the Directive, the certifying body shall issue a type examination certificate. The certificate shall contain the name and address of the manufacturer, the conclusions of the control and the data necessary for the identification of the approved type.

5.1

A list of significant parts of the technical documentation shall be annexed to the certificate and a copy retained by the certifying body.

5.2

If it refuses to grant such a certificate to the manufacturer or its representative established in Switzerland, the certification body shall give reasons for its refusal in detail.

An appeal procedure must be provided for.

6

The applicant shall inform the attestation body, which holds the technical file relating to the type certificate, of all modifications of the device or of the approved protection system. The product must be re-approved where these amendments may jeopardize compliance with the essential requirements or the intended conditions of use. The new approval shall be issued in the form of a supplement to the original certificate.

7

Each attestation body shall communicate to others useful information concerning type examination certificates and supplements issued or withdrawn.

8

The other certifying bodies may obtain a copy of the type examination certificates and/or their supplements. The annexes to these documents are to be made available to the other certifying bodies.

9

The manufacturer or his representative established in Switzerland shall, together with the technical file, keep a copy of the examination certificates of type and their supplements for a period of at least ten years from the date of the last date of manufacture of the device or Protection system.

Where neither the manufacturer nor his representative is established in Switzerland, the obligation to keep the technical file available shall be the responsibility of the person responsible for placing the product on the market.

State 1 ^Er December 2013

(art. 9)

Production Quality Assurance Procedure

1

"Quality assurance of production" is the procedure by which the manufacturer fulfils the obligations laid down in c. 2 ensures and declares that the products concerned comply with the type described in the type examination certificate and comply with the requirements of the directive applicable to them. The manufacturer or his representative established in Switzerland shall draw up a written declaration of conformity.

2

The manufacturer shall apply an approved production quality system, carry out an inspection and testing of the finished apparatus provided for in the c. 3 and is subject to the supervision referred to in c. 4.

3

Quality System

3.1

The manufacturer shall submit a request for the evaluation of its quality system to an attestation of conformity of its choice, for the devices concerned.

The application includes:

-: All relevant information for the category of products envisaged;
-: Documentation of the quality system;
-: Technical documentation for the approved type and a copy of the type examination certificate.

3.2

The quality system shall ensure the conformity of the devices to the type described in the type examination certificate and the requirements of the directive applicable to them.

All elements, requirements and provisions adopted by the manufacturer must be collated in a systematic and orderly manner in a documentation in the form of written measures, procedures and instructions. This quality system documentation should allow for a consistent interpretation of the programs, plans, manuals and quality records.

This documentation includes, in particular, an adequate description:

-: The quality objectives, the organizational chart, the responsibilities of the managers and their authority regarding the quality of the equipment;
-: Manufacturing processes, quality control techniques and quality assurance and systematic techniques and actions that will be applied;
-: Examinations and tests to be carried out before, during and after manufacture, with an indication of the frequency with which they will take place;
-: Quality records such as inspection reports and test and calibration data, reports on qualification of personnel involved, etc.;
-: Monitoring means to control the achievement of the required quality of the equipment and the efficient operation of the quality system.

3.3

The certifying body shall assess the quality system in order to determine whether it meets the requirements referred to in c. 3.2. It shall presume compliance with these requirements of quality systems implementing the corresponding harmonised standard. The audit team will have at least one member experienced in the evaluation of the device's technology. The evaluation procedure shall include an inspection visit to the manufacturer's premises. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the monitoring and the reasoned assessment decision.

3.4

The manufacturer undertakes to fulfil the obligations arising from the quality system as approved and to maintain it so that it remains adequate and effective.

The manufacturer or his representative shall inform the attestation body which has approved the quality system of any proposed adaptation of this system.

The certifying body shall evaluate the proposed changes and decide whether the modified quality system will continue to meet the requirements referred to in c. 3.2 or if there is a need for a new assessment.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the monitoring and the reasoned assessment decision.

4

Supervision under the responsibility of the certifying body

4.1

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

4.2

The manufacturer shall grant the certification body access to, for inspection, the places of manufacture, inspection, testing and storage and shall provide it with all necessary information, in particular:

-: Documentation of the quality system;
-: Quality records such as inspection reports and test and calibration data, personnel qualification reports, etc.

4.3

The attestation body shall carry out periodic audits to ensure that the manufacturer maintains and applies the quality system; it shall provide an audit report to the manufacturer.

4.4

In addition, the certification body may make unannounced visits to the manufacturer. During such visits, tests may be carried out or carried out to verify the proper functioning of the quality system if necessary; it shall provide the manufacturer with a visitation report and, if tested, a test report.

5

The manufacturer shall keep at the disposal of the national authorities for a period of at least ten years from the last date of manufacture of the appliance:

-: The documentation referred to in c. 3.1, second indent;
-: Adaptations referred to in c. 3.4, second paragraph;
-: The decisions and reports of the attestation body referred to in c. 3.4, last paragraph and c. 4.3 and 4.4.

6

Each attestation body shall communicate to others the relevant information concerning the approvals of quality systems issued and withdrawn.

State 1 ^Er December 2013

(art. 9)

"Product Verification" procedure

1: "Product verification" shall be the procedure by which the manufacturer or his representative established in Switzerland ensures and declares that the devices which have been submitted to the provisions of point 3 are in conformity with the type described in the examination certificate of Type and meet the corresponding requirements of the Directive.
2: The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the conformity of the devices to the type described in the type examination certificate and the requirements of the applicable Directive. The manufacturer or his representative established in Switzerland shall draw up a declaration of conformity.
3: The certificate of conformity shall carry out the appropriate tests and tests, in order to verify the conformity of the device with the corresponding requirements of the Directive, by checking and testing each device as specified in point 4.
The manufacturer or his representative shall keep a copy of the declaration of conformity for a period of at least ten years from the last date of manufacture of the device.
4: Audit by control and testing of each device
4.1: All devices shall be examined individually and appropriate tests defined in the applicable standard (s) referred to in s. 6, or equivalent tests shall be carried out in order to verify their conformity to the type described in the type examination certificate and the applicable requirements of the Directive.
4.2: The certifying body shall affix or cause to be affixed its identification number on each approved device and shall draw up a written attestation of conformity with regard to the tests carried out.
4.3: The manufacturer or his representative shall be able to submit, on request, the certificates of conformity of the attestation body.

State 1 ^Er December 2013

(art. 9)

"Compliance with type" procedure

1: "Conformity to the type" is the part of the procedure by which the manufacturer or his representative established in Switzerland ensures and declares that the devices concerned conform to the type described in the type examination certificate and meet the requirements Of the directive applicable to them. The manufacturer or his representative established in Switzerland shall draw up a written declaration of conformity.
2: The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the conformity of the devices manufactured to the type described in the type examination certificate and the corresponding requirements of the Directive.
3: The manufacturer or his representative shall keep a copy of the declaration of conformity for a period of at least ten years from the last date of manufacture of the device. Where neither the manufacturer nor his representative is established in Switzerland, this obligation to maintain the technical documentation shall be the responsibility of the person responsible for placing the device or the protection system on the market.
For each device manufactured, the manufacturer shall carry out or cause to be tested the technical aspects of protection against the explosion. The tests are carried out under the responsibility of a designated body chosen by the manufacturer.
The manufacturer shall, under the responsibility of the designated body, affix the identification number of the designated organism during the manufacturing process.

State 1 ^Er December 2013

(art. 9)

"Product Quality Assurance" procedure

1

"Product quality assurance" is the procedure by which the manufacturer satisfies the obligations of the c. 2 ensures and declares that the equipment conforms to the type described in the type examination certificate. The manufacturer or his representative established in Switzerland shall draw up a written declaration of conformity.

2

The manufacturer shall apply a quality approved system for the final inspection of the device and for testing, as specified in the c. 3, and is subject to the supervision referred to in c. 4.

3

Quality System

3.1

The manufacturer shall submit a request for the evaluation of its quality system to an attestation of conformity of its choice, for the devices.

The application includes:

-: All appropriate information for the category of the device being considered;
-: Documentation of the quality system;
-: Technical documentation for the approved type and a copy of the type examination certificate.

3.2

As part of the quality system, each device shall be examined and tested, as defined in the applicable standard (s) referred to in s. 6, or equivalent tests shall be carried out to verify its conformity with the corresponding requirements of the Directive. All elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and rational manner in the form of written measures, procedures and instructions. This quality system documentation provides a consistent interpretation of programs, plans, manuals and quality records.

This documentation includes, in particular, an adequate description:

-: Quality objectives, organizational chart, executive responsibilities and product quality authorities;
-: Tests and tests to be carried out after manufacture;
-: Ways of verifying the effective functioning of the quality system;
-: Quality records such as inspection reports and test data, calibration data, reports on qualification of personnel involved, etc.

3.3

The certifying body shall assess the quality system in order to determine whether it meets the requirements referred to in c. 3.2. It assumes compliance with these requirements for quality systems that implement the corresponding harmonised standard. The audit team shall comprise at least one member who has acquired, as an evaluator, the experience of the technology of the product concerned. The evaluation procedure includes a visit to the manufacturer's premises. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the monitoring and the reasoned assessment decision.

3.4

The manufacturer undertakes to fulfil the obligations arising from the quality system as approved and to maintain it so that it remains adequate and effective.

The manufacturer or his representative shall inform the attestation body which has approved the quality system of any project to adapt the quality system.

The certifying body shall evaluate the proposed amendments and decide whether the modified quality system will still meet the requirements referred to in c. 3.2 or if re-evaluation is required.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the monitoring and the reasoned assessment decision.

4

Supervision under the responsibility of the certifying body

4.1

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

4.2

The manufacturer shall authorize the certification body to access, for inspection purposes, the inspection, testing and storage facilities and shall provide it with all necessary information, including:

-: Documentation of the quality system;
-: Technical documentation;
-: Quality records such as inspection reports and test data, calibration data, reports on qualification of personnel involved, etc.

4.3

The Designated Agency shall carry out periodic audits to ensure that the manufacturer maintains and applies the quality system and provides it with an audit report.

4.4

In addition, the Designated Agency may make unannounced visits to the manufacturer. On the occasion of such visits, the designated body may carry out or have carried out tests to verify the proper functioning of the quality system if necessary; it shall provide the manufacturer with a visit report and, if it has been tested, a report Testing.

5

The manufacturer shall keep at the disposal of the national authorities for a period of at least ten years from the last date of manufacture of the appliance:

-: The documentation referred to in c. 3.1, third indent;
-: Adaptations referred to in c. 3.4, second paragraph;
-: The decisions and reports of the designated organization referred to in c. 3.4, last paragraph and c. 4.3 and 4.4.

6

Each designated body shall communicate to the other designated bodies the relevant information concerning the quality system approvals issued and withdrawn.

State 1 ^Er December 2013

(art. 9)

"Internal Manufacturing Control" procedure

1

"Internal manufacturing control" shall be the procedure by which the manufacturer or his representative established in Switzerland, who fulfils the obligations laid down in point 2, shall ensure and declare that the devices concerned satisfy the requirements of the Directive which Are applicable to them. The manufacturer or his representative established in Switzerland shall draw up a declaration of conformity in writing.

2

The manufacturer shall establish the technical documentation described in c. 3; the manufacturer or his representative established in Switzerland shall keep this documentation available to the national authorities for inspection for a period of at least ten years from the date of the last date of manufacture of the device.

Where neither the manufacturer nor his representative is established in Switzerland, this obligation to maintain the technical documentation shall be the responsibility of the person responsible for placing the device on the market.

3

The technical documentation shall make it possible to assess the conformity of the device with the corresponding requirements of the Directive. It shall cover, to the extent necessary for this evaluation, the design, manufacture and operation of the apparatus. It contains:

-: A general description of the devices;
-: Design and manufacturing drawings, as well as diagrams of components, subassemblies, circuits, etc.;
-: The descriptions and explanations necessary for the understanding of the above drawings and diagrams and the operation of the apparatus;
-: A list of the standards that have been applied, in whole or in part, and a description of the solutions adopted to meet the safety aspects of this directive when standards have not been applied;
-: Results of design calculations, checks carried out, etc.;
-: Test reports.

4

The manufacturer or his representative shall retain, together with the technical documentation, a copy of the declaration of conformity.

5

The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the conformity of manufactured appliances with the technical documentation referred to in point 2 and the requirements of the directive applicable to them.

State 1 ^Er December 2013

(art. 9)

"Device Check" procedure

1

"Unit verification" is the procedure by which the manufacturer insures and declares that the device or system of protection that has obtained the certificate referred to in c. 2 complies with the requirements of the directive applicable to them. The manufacturer or his representative established in Switzerland shall draw up a declaration of conformity.

2

The conformity certification body shall examine the device or system of protection and carry out the appropriate tests defined in the applicable standard (s) referred to in Art. 6, or equivalent tests to verify its conformity with the requirements of the applicable Directive.

The certifying body shall affix or cause to be affixed its identification number on the device or system of protection approved and shall establish a certificate of conformity relating to the tests carried out.

3

The purpose of the technical documentation is to enable the assessment of compliance with the requirements of the Directive and the understanding of the design, manufacture and operation of the device or system of protection.

This documentation contains, to the extent necessary for the evaluation:

-: A general description of the type;
-: Design and manufacturing drawings, as well as component diagrams, subassemblies, circuits, etc.;
-: The descriptions and explanations necessary for the understanding of the said drawings and diagrams and the operation of the apparatus or the system of protection;
-: A list of the standards referred to in s. 6, applied in whole or in part, and descriptions of the solutions adopted to meet the essential requirements where these standards have not been applied;
-: Results of design calculations performed, examinations carried out, etc.;
-: Test reports.

State 1 ^Er December 2013

RS 734.6 Order of 2 March 1998 on apparatus and protection systems for use in explosive atmospheres (OSPEX)

Original Language Title: RS 734.6 Ordonnance du 2 mars 1998 sur les appareils et les systèmes de protection destinés à être utilisés en atmosphères explosibles (OSPEX)

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734.6

Order on apparatus and systems of protection intended for use in explosive atmospheres

(OSPEX)

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