Rs 734.6 Order Of 2 March 1998 On Equipment And Protective Systems Intended For Use In Potentially 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 equipment and protective systems intended for use in potentially explosive atmospheres (OSPEX) of 2 March 1998 (status on December 1, 2013) the Swiss federal Council, having regard to art. 3 and 55, ch. 3, of the law of June 24, 1902 on the electrical installations (LIE), and pursuant to the Federal law of June 12, 2009, on the safety of products (Prsl), and of the Federal Act of 6 October 1995 on technical barriers to trade (LETC), stop: Section 1 provisions general article 1 scope this order applies to equipment and protective systems and accessories devices designed to be used in potentially explosive atmospheres.
It applies not to the items listed in art. 1, c. 4 of the EC directive 94/9 of 23 March 1994 on the approximation of the laws of the Member States for equipment and protective systems intended for use in potentially explosive atmospheres (directive).

OJ L 100, 19.4.1994, p. 1, corrected by OJ L 257 of the 10.10.96, p. 44. The text of the directive can be obtained from the Swiss Association for Standardization, Burglistr. 29, 8400 Winterthur (www.snv.ch).

S. 2 definitions for the purposes of this order, means a. equipment: machines, equipment, fixed or mobile, devices controls, instrumentation and systems of detection and prevention which, alone or in combination, are intended production, transport, storage, measurement, control or energy conversion and transformation of materials and that , by potential ignition sources that are appropriate to them, may cause the triggering of an explosion; b. protection systems: the emerging devices other than the device components defined above, whose function is to immediately stop the explosions or limit the area affected and which are placed on the market as autonomous function systems; c. Accessories: safety devices control and adjustment which, not be used in potentially explosive atmospheres, are necessary or useful to the safe functioning of apparatus or protection systems; d. components: essential parts for the safe functioning of equipment and protective systems but have no autonomous function; e. explosive atmosphere: the mixture under atmospheric conditions, of air with flammable substances in the form of gas , vapors, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture; f. atmospheres: an atmosphere likely to become explosive due to local or operational; conditions g. intended use: the use of equipment, systems of protection and accessories corresponding to the groups and equipment categories as defined in annex 1 as well as the indications given by the manufacturer and which respect conditioning operation course units.

S. 3 placing on the market by "placing on the market" means the transfer or delivery, for payment or not, equipment, protective systems and accessories devices to be marketed or used in Switzerland.
Commissioning of equipment, protective systems and accessories devices for professional purposes in the enterprise includes a placing on the market, if it has not already taken place under para. 1.
...

Repealed by c. I 2 W of June 11, 2010, adapting sectoral orders in the field of the safety of the products, with effect from 1 July. 2010 (2010 2749 RO).

S. 4 security appliances, systems of protection and accessories devices installed and maintained in an appropriate manner must endanger persons or things in the case of intended use.

Section 2 placing on the market of equipment, protective systems and devices accessories new s. 5 basic requirements devices, systems of protection and accessories can be placed on the market only if they meet the basic requirements set out in annex II to the directive.

S. 6 technical standards the federal Office of energy (Agency) means, with the agreement of the federal Office of external economic affairs, technical standards appropriate to fulfill the basic requirements.
Insofar as possible, it takes harmonized international standards.
The Office can load independent Swiss standardization bodies to prepare technical standards.
Designated technical standards are published in the Feuille fédérale with titles and references.

The lists of the titles of the standards designated as well as their texts are obtained from the Swiss Association for Standardization, Burglistr. 29, 8400 Winterthur (www.snv.ch).

S. 7 declaration of conformity the person who places on the market a device, a system of protection or an accessory must be able to present a declaration of conformity showing that the product complies with the essential requirements and the conformity assessment procedures prescribed in art. 10 have been conducted.
If the appliance, the protection system or the accessory is subject to several regulations requiring a declaration of compliance, a single declaration is sufficient.
Written in one of the official languages of the Switzerland or in English, the declaration of conformity includes the following information: a. the name or logo and address of the manufacturer or his representative established in Switzerland; b. a description of the appliance of protection system or the accessory; c. the requirements and technical standards or other specifications applied; d. where appropriate the name and address of the body test and certificate of conformity according to the art. 11; e. the name and address of the person who signs the declaration of conformity for the manufacturer or his representative established in Switzerland.

For the components according to the art. 2, let. d, just a written certificate of the manufacturer. It must show that components comply with the requirements of this Ordinance. It must also indicate the characteristics of the components as well as the conditions for incorporation into a device, a system of protection or an accessory that contribute to what they meet the basic requirements.
The declaration of conformity or the certificate of the manufacturer must be able to be made during ten years of production of the unit, the system of protection or of the accessory. In the case of series production, the period shall run from production of the last copy.

S. 8 the equipment requirements, systems of protection and accessories devices manufactured in accordance with the technical standards referred to in art. 6 are deemed meet the basic requirements.
If these standards are only partially or not at all applied, the person who places on the market of devices, accessorial devices or protection systems must be able to prove that they satisfy some other way the basic requirements.
One who puts on the market must be able to submit a technical file allowing the executing agency (art. 14) to check that the basic requirements are met.

S. 9 technical file written in one of the official languages of the Switzerland or in English, the technical dossier should provide the following information: a. a general description of the appliance, system protection or accessory; b. an indication of measures ensuring the conformity of the appliance, the protection system or accessory device with the essential requirements mentioned in art. 5; c. the parts needed the procedure for assessment of conformity according to art. 10. the technical file may be written in another language if the information provided for its assessment are given in one of the official languages of the Switzerland or in English.
The technical dossier must be presented for ten years from the production of devices, systems of protection and accessories. In the case of series production, the period shall run from production of the last copy.

S. 10 procedure of conformity assessment for devices of categories M1 and 1 so that for systems of protection, it will lead the "Type-examination" procedure (annex 2) in combination with the procedure "Production quality Assurance" (Appendix 3) or with the 'Product Verification' procedure (annex 4).
For internal combustion engines and electrical appliances in the category M2 and 2, it will lead the "Type-examination" procedure (annex 2), in combination with the "Conformity to type" procedure (Appendix 5) or with the procedure "Product quality Assurance" (Appendix 6).
For the other devices of categories M2 and 2, it will lead the procedure 'Internal control of production' (annex 7) and the necessary parts will be entrusted to a body under article 11 to be preserved.
For devices of category 3, it will lead the procedure 'Internal control of production' (annex 7).
In lieu of the procedures according to the al. 1 to 4, in all cases can lead the 'Unit Verification' procedure (annex 8).
If accessories should be put on the market at the same time as a device, the procedures prescribed in the al. 1 to 5 will be conducted jointly for the appliance and accessories devices.
The procedures laid down for each category of equipment shall apply by analogy to the components.

For the safety aspects according to annex II, c. 1.2.7 of the directive can in all cases also lead the procedure 'Internal control of production' (annex 7).
When justified, the Executive Body may allow the placing on the market or putting into service of equipment, protective systems and accessories devices without the procedures provided here have been conducted.

S. 11 bodies test and certificate of conformity testing and certification of conformity bodies that emit reports or certificates according to art. 10 must: a. be accredited in accordance with the Ordinance of 17 June 1996 on accreditation and designation; b. be recognized in Switzerland under agreements international, co. be entitled otherwise by Swiss law.

One that refers to a folder from one body other than those referred to in para. 1 must demonstrate credibly that the methods and skills of the said body meet the Swiss requirements (art. 18, al. 2, LETC).

SR 946.512 Section 3 placing on the market of appliances s. 12. equipment, systems of protection and accessories devices used may not be placed on the market unless they meet the requirements in force at the time of their first placing on the market.
For equipment, protective systems and accessories which some important organs for security have been processed or renewed are subject, with respect to these bodies, the provisions governing the placing on the market of new equipment.

Section 4 exhibitions and presentations article 13. the devices, systems of protection and accessories not satisfying the requirements for the placing on the market cannot be exposed or presented if the following conditions are met: a. it is clear that such material are not proof that they satisfy the legal requirements, and that they cannot therefore be placed on the market; ETB. the measures necessary for the protection of persons and things have been taken.

Section 5 article Market Surveillance 14 principle the Executive Body shall ensure that devices, systems of protection and accessories devices placed on the market correspond to the requirements of this order. To this end, he proceeded to scores and examines based indices that a product does not correspond to the requirements.
Are implementing bodies: a. the appellate body according to art. 21 LIE for equipment, protective systems and accessories devices ignition as well as for electrical installations in potentially explosive atmospheres areas; b. the organs of performance within the meaning of art. 20 order of 19 May 2010 on the safety of products (PRSV) for other devices, systems of protection and accessories.

Implementing bodies may request the authority to provide customs, for a specified time, information on imports of equipment, systems of protection and well-defined accessories devices.

New content according to chapter II 2 of Schedule 4 to the West of 19 May 2010 on the safety of products, in force since 1 Jul. 2010 (2010 2583 RO).
RS 930.111 s. 15 skill of implementing bodies the executive body is empowered, under the supervision of the market, to require documents and information necessary to demonstrate compliance devices, systems of protection and accessory devices, to take samples and to conduct audits; It can enter the premises of the company during normal working hours.
If the person responsible for the placing on the market fails to provide all or part of the pieces requested within the period fixed by the Executive Body, the latter may order an audit. The cost is supported by the person responsible for the placing on the market.
The Executive Body may also order an audit when a. does not show clearly enough of the declaration of conformity according to art. 7 that equipment, systems of protection and accessories meet the requirements; b. a device, a system of protection or an accessory may not correspond to this folder.

If the verification provided in the al. 3 shows that devices, accessorial devices or protection systems do not meet the requirements, the cost in is supported by the person who is making the placing on the market.
Before ordering the audit, the Executive Body gives to the person responsible for the placing on the market the opportunity to express themselves. A device, a system of protection or an accessory chosen by the executing agency will be made free of charge available for verification.

New content according to chapter I 2 W of June 11, 2010, adapting sectoral orders in the field of the safety of products, in force since 1 Jul. 2010 (2010 2749 RO).

S. 16 measures if the control or audit reveals that provisions of this order have been violated, the Executive Body ordered measures in accordance with art. 10, al. 2 to 5, Prsl.
...
In accordance with the provisions of the regulation of fees applicable, implementing bodies receive a fee and put the costs borne by the persons concerned to: a. controls as it turns out that the product does not meet the requirements; b. decisions taken in respect of control of equipment and protective systems intended for use in potentially explosive atmospheres.

The executive body is competent to grant international administrative assistance in respect of art. 22 HARMONISED.

New content according to chapter I 2 W of June 11, 2010, adapting sectoral orders in the field of the safety of products, in force since 1 Jul. 2010 (2010 2749 RO).
Repealed by c. I 2 W of June 11, 2010, adapting sectoral orders in the field of the safety of the products, with effect from 1 July. 2010 (2010 2749 RO).
New content according to Chapter 4 of the annex to the O of 9 oct. 2013, in effect since Dec. 1. 2013 (2013 3509 RO).

S. 17 coordination...
Implementing bodies shall inform each other and the commission informed about the results of their inspections and announce in particular deficiencies on equipment, protective systems and accessories.

Repealed by c. II 2 of Schedule 4 to the West of 19 May 2010 on the safety of products, with effect from 1 July. 2010 (2010 2583 RO).

Section 6 channel of appeal art. 18. Appeals against the decisions of implementing bodies referred to in art. 14, al. 2, are governed, in the case of the let. a, by art. 23 LIE, and in the case of the let. (b), by art. 15 Prsl.

New content according to chapter II 2 of Schedule 4 to the West of 19 May 2010 on the safety of products, in force since 1 Jul. 2010 (2010 2583 RO).

Section 7 provisions finals s. 19 transitional provisions...
If devices, protective systems or accessories are verified according to the technical standards of the generation A or B, placing on the market requires the prior approval of the Federal Inspectorate for heavy current installations hard. Approval is given if the test reports of a body under article 11 establish the conformity of apparatus, protective systems or accessories devices to the basic requirements.
If devices, protective systems or accessories 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 Inspectorate for heavy current installations hard. Approval is given if the test reports, test reports or certificates of conformity of an organ according to the art. 11 establish the conformity of apparatus, protective systems or accessories devices to the basic requirements.

Repealed by ch. IV 26 W of 22 August 2007 on the formal update of federal law, with effect from 1 Jan. 2008 (2007 4477 RO).

S. 20 entry into force this order comes into force April 1, 1998.

Annex 1 (art. 2) groups and equipment categories 1 equipment group I (M) 1.1 category M1 category M1 comprises equipment designed and, where necessary, equipped with special means of protection additional to operate in accordance with the operational parameters established by the manufacturer and ensuring a very high level of protection.
Aircraft in this category are for underground mines and parts of their facilities endangered by firedamp or combustible dusts.
These devices must remain operational even in the event of rare trouble in explosive atmospheres, they are equipped with means of protection such that:-in the event of failure of one means of protection, the level of security required remains assured by at least a second means of independent protection, or - in case of two independent defects, the required level of safety is ensured.

These devices shall comply with the additional requirements referred to in annex II, Figure 2.0.1.

1.2 category M2 M2 category includes devices designed to function in compliance with the operational parameters established by the manufacturer and ensuring a high level of protection.
Aircraft in this category are intended for underground mines and parts of their surface facilities that may be endangered by firedamp or combustible dust.

If the atmosphere becomes explosive, the power supply of these devices must be cut.
Means of protection these devices provide the level of security required in normal operation, even in difficult operating conditions, including brutal the appliance usage and in changing ambient conditions.
These devices shall comply with the additional requirements set out in annex II c. 2.0.2.

2 Group II 2.1 category 1 category 1 comprises equipment designed to function in compliance with the operational parameters established by the manufacturer and ensuring a very high level of protection.
Aircraft in this category are intended for an environment where reigns constantly, or for a long period, or frequently an explosive atmosphere due to the mixture of air with gases, vapours, mists or dusts.
These devices to ensure the level of security required, even in the event of unusual upheaval, they are equipped with means of protection such that:-in the event of failure of one means of protection, the level of security required remains assured by at least a second means of independent protection, or - in case of two independent defects, the required level of safety is ensured.

Equipment in this category must meet the additional requirements referred to in annex II c. 2.1.

2.2 category 2 category 2 comprises equipment designed to function in compliance with the operational parameters established by the manufacturer and ensuring a high level of protection.
Aircraft in this category are intended for an environment where occasionally require an explosive atmosphere due to gases, vapours, mists or the mixture of air and dust.
How have these devices provide the level of security required, even in the event of frequent disturbances or malfunctions which usually take into account.
These devices shall comply with the additional requirements referred to in annex II, ch. 2.2.

2.3 category 3 category 3 comprises equipment designed to function in compliance with the operational parameters established by the manufacturer and ensuring a normal level of protection.
Aircraft in this category are intended for an environment where it should not expect an explosive atmosphere due to gases, vapours, mists or the mixture of air and dust and where such an atmosphere, if it occurs, does not remain only briefly.
Equipment in this category provide the level of protection required for normal operation.
These devices shall comply with the additional requirements referred to in annex II, ch. 2.3.

State on December 1, 2013 Appendix 2 (art. 9) Procedure "Type-examination" 1 "Type examination" is the procedure whereby an attestation of compliance body ascertains and certifies that a representative sample of the production envisaged meets the relevant provisions of the directive.2 the application for type-examination shall be submitted by the manufacturer (or its representative in Switzerland) with a body for certification of his choice. The application shall include:-the name and address of the manufacturer, and the name and address of the representative if the application is made by the latter; - a written declaration specifying that the same application has not been lodged with another body of attestation; - the technical documentation described in ch. 3.

The applicant must place at the disposal of the certification body a representative sample of the production concerned, hereinafter referred to as the 'type '. The certification body may request further specimens if the test programme so requires.
3. the technical dossier must allow to assess whether the product corresponds to the requirements of the directive. Insofar as this evaluation so requires, it must cover the design, manufacture and operation of the product and contain:-a general description of the type; - industrial design and manufacturing, as well as diagrams of components, sub-assemblies, circuits, etc.; -the descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product; - a list of standards mentioned in art. 6, applied wholly or in part, and descriptions of the solutions adopted to meet the essential requirements where the standards have not been applied, - results of design calculations made, examinations; etc.; -test reports.

4. the attestation of conformity: 4.1 body examines the technical file, verifies that the type has been manufactured in accordance with it and areas designed according to the applicable provisions of the standards referred to in art. 6, as well as those whose design does not rely on those provisions; 4.2 perform or have performed the appropriate examinations and necessary tests to check whether the solutions adopted by the manufacturer meet the essential requirements of the directive where the standards referred to in art. 6 have not been applied; 4.3 perform or have performed the appropriate examinations and necessary tests to check whether, where the manufacturer has chosen to apply the standards taken into account, these have actually been applied; 4.4 agrees with the applicant on the location where the examinations and necessary tests will be effectues.5 where the type meets the provisions of the directive the certification body shall issue a type-examination certificate. The certificate must contain the name and address of the manufacturer, conclusions of control and the necessary data for identification of the type approuve.5.1 a list of the significant technical documentation parts is annexed to the certificate and a copy kept by the appellate attestation.5.2 if it refuses to issue such a certificate to the manufacturer or his representative established in Switzerland, the certification body justifies its refusal to detail. An appeal procedure must be provided.
6. the applicant shall inform the certification body, which holds the technical dossier for the type certificate of all modifications of the device or of the approved protection system. The product must be subject to further approval where such changes may affect conformity with the essential requirements or the intended conditions of use. The additional approval is given in the form of an addition to the initiale.7 certificate each certification body communicate other relevant information concerning type-examination certificates and additions issued or retires.8 other certification bodies may obtain a copy of the certificates of review type and/or their additions. The annexes to these documents are required at the disposal of the other organs of attestation.9 the manufacturer or his representative established in Switzerland maintains, with the technical dossier, a copy of examination certificates of type and their additions for a period of at least ten years from the last date of manufacture of the unit or the system of protection. Where neither the manufacturer nor his representative are established in Switzerland, the obligation to keep available the technical dossier is the responsibility the person responsible for placing the product on the market.

State on December 1, 2013 Appendix 3 (art. 9) Procedure "Production quality Assurance" 1 "Production quality assurance" is the procedure whereby the manufacturer who fulfils the obligations provided for in the c. 2 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the requirements of the directive which apply to them. The manufacturer or his representative established in Switzerland draw up a written declaration of conform.2 manufacturer must apply an approved quality of the production system, conduct inspection and tests of finished devices ch. 3-under and is subject to the monitoring referred to in ch. 4.3 qualite3.1 introduces manufacturer system an application for assessment of his quality system with a body of attestation of conformity of his choice for the appliances concerned. The application must include: - all relevant information for the category of planned products; - the quality system documentation; - the technical documentation for the approved type and a copy of the type-examination certificate.

3.2 the quality system must ensure conformity of appliances with the type as described in the EC examination certificate type and the requirements of the directive which apply to them. All the elements, requirements and provisions adopted by the manufacturer must be met by a systematic and orderly manner in documentation in the form of measures, procedures and written instructions. This quality system documentation must permit a consistent interpretation of programmes, plans, manuals and quality records.
This documentation shall include in particular an adequate description:


-the quality objectives, the organizational structure, responsibilities frameworks and their powers with regard to equipment quality; - manufacturing processes, techniques of control and assurance of quality and techniques and systematic actions that will be used; - the examinations and tests that will be carried out before, during and after manufacture, with indication of the frequency with which they will take place; - files such as inspection reports and data testing and calibration, reports on qualifications of the staff concerned, etc.; -means of surveillance to monitor the achievement of the required quality of the appliances and the effective operation of the quality system.

3.3 certification body evaluates the quality system to determine whether it satisfies the requirements referred to in 3.2 c.. It shall presume conformity with these requirements of quality systems that implement the relevant harmonized standard. The auditing team must include at least one member with experience in the assessment of the technology of the respective device. The assessment procedure includes an inspection visit in the facilities of the manufacturer. The decision is notified to the manufacturer. The notification contains the conclusions of the examination and decision of assessment motivee.3.4 the manufacturer undertakes to fulfil the obligations arising from the quality system as approved and to uphold it so that it remains adequate and efficient. The manufacturer or its representative shall inform the certification body that has approved the quality system of any adjustments contemplated by this system.
Certification body evaluate the modifications proposed and decide whether the modified quality system will continue to meet the requirements referred to in 3.2 c. or if there is a new assessment.
It shall notify its decision to the manufacturer. The notification contains the conclusions of the examination and the reasoned assessment decision.
4 monitoring under the responsibility of the body of attestation4.1 the purpose of surveillance is to ensure that the manufacturer fulfils the obligations arising from the approved system of qualite.4.2 the manufacturer attaches to the body of certificate access, for inspection, to the locations of manufacture, inspection, testing and storage and must provide all necessary information, including: - the quality system documentation; - files such as inspection reports and tests and calibration data reports on qualifications of the staff concerned, etc.

4.3 certification body periodically carry out audits to make sure that the manufacturer maintains and applies the quality system; It provides an audit report to the fabricant.4.4 in addition, the certification body may pay unannounced visits to the manufacturer. On the occasion of such visits, it can carry out or have carried out tests to verify the proper functioning of the needed quality system; It provides to the manufacturer a visit report and, if there were a test, an essai.5 report the manufacturer wishes to 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 3.1, second indent, c.; - the adjustments referred to in Chapter 3.4, second subparagraph; - the decisions and reports from the certification body referred to in 3.4, c. , last paragraph and c. 4.3 and 4.4.

6. each body certification communicates to other relevant information concerning the quality system approvals issued and withdrawn.

State on December 1, 2013 Appendix 4 (art. 9) Procedure «Product Verification» 1 «Product verification» is the procedure whereby the manufacturer or his representative established in Switzerland ensures and declares that the devices which have been subjected to the provisions of point 3 are conform to the type described in the type-examination certificate and satisfy the relevant requirements of the directive.2 the manufacturer shall take all measures necessary so that the manufacturing process ensures compliance appliances with the type as described in the EC examination certificate type and the requirements of the directive that apply. The manufacturer or his representative established in Switzerland draw up a declaration of conformite.3 the body of attestation of conformity conducts the examinations and appropriate tests, to check the conformity of the equipment with the relevant requirements of the directive, by control and testing of every product as specified in point 4. manufacturer or his representative shall retain 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 verification by examination and testing of each appareil4.1 all appliances must be individually examined and appropriate tests defined in the relevant standards referred to in art. 6, or equivalent tests are carried out to verify their conformity with the type as described in the EC type-examination certificate and with the requirements of the directive.4.2 certification body must affix or affixed its identification number to each approved product and draw a written certificate of conformity relating to the tests effectues.4.3 the manufacturer or his representative is able to produce, upon request, certificates of compliance by the certification body.

State on December 1, 2013 Appendix 5 (art. 9) Procedure ' conformity to the type ' 1 ' compliance to the type» is the part of the procedure whereby the manufacturer or his representative established in Switzerland ensures and declares that concerned devices conform to the type described in the EC type-examination certificate and satisfy the requirements of the directive which apply to them. The manufacturer or his representative established in Switzerland draw up a written declaration of conform.2 the manufacturer shall take all measures necessary to ensure that the manufacturing process ensures conformity of the devices manufactured with the type as described in the EC examination certificate type and the relevant requirements of the manufacturer directive.3 or his representative shall retain 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 are established in Switzerland, this obligation to keep the technical documentation available falls to the person responsible for the placing on the market of the device or the system of protection. For each manufactured device manufacturer perform or have performed on behalf the tests on the technical aspects of the explosion protection. The tests are carried out under the responsibility of a designated body chosen by the manufacturer.
Under the responsibility of the designated agency, the manufacturer shall affix the identification number during the manufacturing process.

State on December 1, 2013 Appendix 6 (art. 9) Procedure "Product quality Assurance" 1 "Product quality assurance" is the procedure whereby the manufacturer who satisfies the obligations of c. 2 ensures and declares that the equipment conforms to the type described in the EC type-examination certificate. The manufacturer or his representative established in Switzerland draw up a written declaration of conform.2 the manufacturer applies a system approved quality for the final of the appliance and for testing inspection, as specified in Chapter 3, and is subject to surveillance as specified in 4.3, c. system qualite3.1 the manufacturer submits an application for assessment of his quality system with a body of attestation of conformity of his choice , for devices. The application must include: - all the relevant information for the appliance category envisaged; - the documentation on the quality system; - the technical documentation for the approved type and a copy of the type-examination certificate.

3.2 under the quality system, each appliance is examined and the appropriate tests, defined in the relevant standards referred to in art. 6, or equivalent tests are carried out to check its conformity with the relevant requirements of the directive. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and rational manner in the form of measures, procedures and written instructions. This quality system documentation must permit uniform interpretation of programmes, plans, manuals and quality records. This documentation shall include in particular an adequate description: - of the quality objectives, the organization chart, the responsibilities of executives and their powers in the quality of the products; - controls and tests that will be carried out after manufacture; - means to verify the effective functioning of the system of quality; - the quality records, such as inspection reports and test data calibration data, reports on the qualifications of the staff concerned, etc.


3.3 certification body evaluates the quality system to determine whether it satisfies the requirements referred to in 3.2 c.. It shall presume conformity with these requirements for quality systems that implement the relevant harmonized standard. The auditing team includes at least one member with experience as an assessor in the of the technology of the product concerned. The assessment procedure includes a visit at the premises of the manufacturer. The decision is notified to the manufacturer. The notification contains the conclusions of the examination and decision of assessment motivee.3.4 the manufacturer undertakes to fulfil the obligations arising from the quality system as approved and to uphold it so that it remains adequate and efficient. The manufacturer or his representative shall inform the certification body that has approved the quality system of any adaptation of the quality system project.
The certification body evaluate the changes proposed and decides if modified quality system still will meet the requirements referred to in Chapter 3.2 or whether a re-assessment is required.
It shall notify its decision to the manufacturer. The notification contains the conclusions of the examination and the reasoned assessment decision.
4 monitoring under the responsibility of the body of attestation4.1 the purpose of surveillance is to make sure that the manufacturer fulfils the obligations arising from the quality approuve.4.2 system the manufacturer authorizes the appellate body certificate access for purposes of inspection, to the locations of inspection, testing and storage and shall provide all the necessary information and in particular:-the quality system documentation, - the technical documentation; - the quality records such as inspection reports and test, calibration data, reports on the qualifications of the staff concerned, etc.

4.3 the designated agency periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and shall provide a report of audit.4.4 in addition, the body may pay unannounced visits to the manufacturer. On the occasion of such visits, the designated agency may carry out or have carried out tests to verify the proper functioning of the system if necessary quality; It provides to the manufacturer a visit report and, if there were a test, an essai.5 report the manufacturer maintains 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 3.1, third indent c; - the adjustments referred to in Chapter 3.4, second subparagraph; - the decisions and reports from the designated body referred to Chapter 3.4 , last paragraph and c. 4.3 and 4.4.

6. each notified body shall communicate to other designated agencies relevant information concerning the quality system approvals issued and withdrawn.

State on December 1, 2013 Appendix 7 (art. 9) Procedure 'Internal control of production' 1 'internal control of production' is the procedure whereby the manufacturer or his representative established in Switzerland, which fulfils the obligations laid down in point 2, ensures and declares that concerned devices meet the requirements of the directive which apply to them. The manufacturer or his representative established in Switzerland established in writing a statement of conform.2 the manufacturer establishes the technical documentation described in ch. 3; the manufacturer or his representative established in Switzerland takes this documentation at the disposal of the national authorities for inspection purposes for a period of at least ten years from the last date of manufacture of the device. Where neither the manufacturer nor his representative are established in Switzerland, this obligation to keep the technical documentation available falls to the person responsible for the placing of the device on the market.
3. the technical documentation must allow assessment of the conformity of the apparatus with the relevant requirements of the directive. It shall to the extent necessary for such assessment, cover the design, manufacture and operation of the device. It contains:-a general description of devices; - industrial design and manufacturing, as well as diagrams of components, sub-assemblies, circuits, etc.; -the descriptions and explanations necessary for understanding drawings and the above diagrams and operation devices; - a list of the standards that have been applied, wholly or in part, and a description of the solutions adopted to satisfy the safety aspects of this directive where standards have not been applied; - the results of the design calculations, checks carried out etc.; -test reports.

4. the manufacturer or his representative maintains, with the technical documentation, a copy of the declaration of conformite.5 the manufacturer shall take all measures necessary so that the manufacturing process assures compliance of the manufactured equipment with the technical documentation referred to in point 2 and the requirements of the directive which apply to them.

State on December 1, 2013 Appendix 8 (art. 9) Procedure 'Unit Verification' 1 "Unit verification" is the procedure whereby the manufacturer ensures and declares that the equipment or protection system which received the certificate referred to c. 2 conforms to the requirements of the directive which apply to them. The manufacturer or his representative established in Switzerland draw up a declaration of conform.2 body of attestation of conformity examines the device or the system of protection and the appropriate tests defined in the relevant standards referred to in art. 6, or of equivalent tests to ensure its conformity with the requirements of the directive applicable. The certification body shall affix or affixed its identification on the device or the approved protection system and draw up a certificate of conformity relating to the tests carried out.
3. the technical documentation is intended to allow assessment of conformity with the requirements of the directive as well as understanding the design, manufacture and operation of the apparatus or protection system. This documentation contains, to the extent necessary for assessment:-a general description of the type; - industrial design and manufacturing, as well as diagrams of components, sub-assemblies, circuits, etc.; -the descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the unit or the system of protection; - a list of standards referred to in art. 6, applied wholly or in part, and descriptions of the solutions adopted to meet the essential requirements where the standards have not been applied, - results of design calculations made, examinations carried out, etc.; -test reports.

State on December 1, 2013

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