Regulations for gas apparatus and equipment.


Date FOR 1994-10-05-919


Affairs Ministry of Justice


Published Dept. In 1994 1653


Commencement 05/10/1994

Edited
FOR-2003-11-06-1317

Changes


For
Norway

Legal

LOV-1971-05-21-47-§6, FOR 1981-03-20, LOV-2002-06-14-20-L-26, LOV-2002-06-14-20-§43, LOV-2002-06-14-20-§44, TO-2002-05-23-770, TO-2002-06-26-728

Promulgated


Short Title
Regulations for gas apparatus and equipment

Chapter Overview:

Chapter 1. Introductory provisions (§§ 1-3)
Chapter 2. General provisions (§§ 4-8)
Chapter 3. Compliance and certification procedures (§§ 9-13)
Chapter 4. Substantive provisions (§§ 14-16)
Appendix I. Basic requirements
Appendix II. Compliance and certification procedures
Appendix III. CE marking and inscriptions
Annex IV. Construction documentation
Annex V. Minimum Criteria for designating notified bodies to be notified

Established by the Directorate for Fire and Explosion 5. October 1994 pursuant to the Act of 21 May 1971 No.. 47 for flammable goods, liquids and gases under pressure § 6, second paragraph, ref. Government and labor ministry delegation decisions of 20 March 1981. (Ref. Act 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, cf. § 44; see. delegated decision of 23 May 2002 no. 770 and delegated decision of 26 June 2002 no. 728.) cf.. EEA special annex no. 2, Volume 3, Chapter V (Council Directive 90/396 / EEC) and the EEA Agreement supplementary agreement special annex no. 2, Volume 6A, Chapter XIX. 3C (Council Directive 93/68 / EEC). Amended July 10, 2002 No.. 815, November 6, 2003 No.. 1317

Chapter 1. Introductory provisions

§ 1. Purpose These regulations shall ensure that gas apparatus and equipment designed, manufactured and assembled so that the apparatus and equipment at any time is in proper condition, thereby preventing damage to life, health, property and the environment.

§ 2. Scope This regulation applies to gas apparatus and equipment that fall under the definition in § 3, and used or intended for use in Norway.
Apparatus specifically designed for use in industrial processes in industrial plants are exempt from the provisions of the regulations.
For gas apparatus and equipment which fall outside the definition in § 3 applies to other provisions set by the central supervisory authority.

§ 3. Definition and explanation of the Regulation, the following terms are understood as follows:
apparatus

-
Gas appliance for cooking, heating, hot water production, cooling, lighting or washing, optionally having a normal temperature not exceeding 105 ° C.

-
Gas burners with combustion air fan and heating units to be equipped with such burners.

Equipment

-
Safety, controlling and regulating devices and subassemblies, which are embedded in gas appliances or mounted in order to constitute a gas appliance, except for gas burners with combustion air fan and heating units to be equipped with such burners.

Gaseous fuels

-
Any fuel which is in gaseous state at a temperature of 15 ° C and a pressure of 100 kPa (1 bar)

Common use

-
When the device is properly installed and regularly maintained in accordance with manufacturer's instructions

-
When the appliance is used by normal variations in gas quality and supply pressure, and

-
When the appliance is used in accordance with its intended purpose or in a way that it can reasonably be expected.

Harmonized standard

-
European standards adopted by CEN or CENELEC in accordance with a mandate from the European Commission and EFTA countries, and which is published in the Official Journal

Notified Body

-
Independent third party organizations which are tasked to conduct conformity assessments in accordance with the EEA Agreement, ref. Annex V.

Conformity assessment

-
Assessment performed by Notified Body and it shows whether a product meets the technical requirements stated in the regulations.

Declaration

-
Declaration by the manufacturer that a product complies with the requirements of the regulations.

Chapter 2. General provisions

§ 4. Obligated Anyone who designs, manufactures, imports or sells gas apparatus and equipment covered by these regulations must adhere.
Located producer outside the European Economic Area concerning the requirements for him equivalent of manufacturer's representative within the EEA.
Regulations apply also notified body when it carries out compliance and certification procedures in accordance with regulations.


§ 5. Regulator central supervisory authority supervises compliance with these regulations, and can make the decisions necessary and set conditions for implementing the regulation. In conjunction with supervisory activities, the provisions of the Act on Inflammable goods, liquids and gases under pressure § 39 accordingly.

§ 6. Appeals Decisions made by the central supervisory authority may be appealed to the Ministry.

§ 7. Penalties, fines, enforcement case of violation of regulations or decisions made in pursuance of this, the provisions on penalties, fines and enforcement in Ch. 7 of the Act on Inflammable goods, liquids and gases under pressure corresponding to the application.

§ 8. Commencement and transitional provision This regulation comes into force on 5 October 1994.
For a transitional period until 31 December 1995, gas apparatus and equipment covered by the present regulations are approved both by the provisions of the regulations concerning flammable goods of 6 . December 1974 Nos. 3 and by provisions of the present regulation. After January 1, 1996 are not permitted to promote gas apparatus and equipment covered by the present regulations if they are not CE marked.

Chapter 3. Compliance and certification procedures

§ 9. Apparatus
1.
Before appliance marketed should a Notified Body to certify that the unit complies with the provisions of this regulation.

2.
Conformity Assessment and Certification of series-produced devices must comply with the EC type-examination as referred to in Annex II 1.

In addition, the appliance before marketing subjected to one of the following procedures chosen by the manufacturer:

-
EC declaration of conformity to type referred to in Annex II Section. 2, or

-
EC declaration of conformity to type (production quality assurance), listed in Annex II Section. 3, or

-
EC declaration of conformity to type (product quality assurance) as listed in Annex II Section. 4, or

-
EC verification as referred to in Annex II section. 5.

3.
Produced appliance as a single unit or in small number, the manufacturer can choose EC verification of devices referred to in Annex II section. 6.

4.
When the procedures noted in chap. 2 and 3 is completed, the manufacturer must equip the device with the CE mark in accordance with § 11

§ 10. Equipment procedures referred to in § 9 shall apply to equipment, except for affixing the CE mark and any issuance of conformity assessment.
The manufacturer shall issue a declaration stating that the equipment complies with those of the provisions of the regulations applicable to the equipment. In the declaration of conformity shall state whether the equipment's characteristics and the conditions for incorporation into an apparatus or mount that will help meet the basic requirements applicable to finished manufactured instruments.
The Declaration to be submitted simultaneously with the equipment.

§ 11. CE marking device or an identification plate attached to the appliance must be equipped with the CE marking and inscriptions specified in Appendix III. Marking should be performed in such a way that it is visible, easy to read and can not be removed. Where the plate is used must be designed so that it can not be reused.
It is prohibited to affix appliance labeling that may mislead third parties with regard to CE-mark the meaning and form design. Any other marking may be affixed appliance or data plate provided that it does CE marking less visible and harder to read.
If it is established that the CE marking is incorrect applied, the manufacturer or his representative within the EEA immediately ensure that the apparatus is brought into compliance with regulatory requirements relating to CE marking and any directions given by the supervisory authority. The supervisory authority shall take appropriate measures to restrict or prohibit the marketing of the product or withdraw it from the market, where the product is brought into compliance with regulatory requirements relating to CE marking.

§ 12. Relations with the basic requirements in other directives included in the apparatus of other directives which are included in the EEA Agreement and which contains provisions on the application of the CE marking, indicating the CE marking that the device also complies with the provisions of these directives.
Can manufacturer according to one or more of these directives choose which scheme he will use during a transitional period, the CE marking only that the device meets the provisions of the directive that the manufacturer uses. The references to the directives must be preceded by the documents, notices or instructions required under this Directive and shall comply with the appliance.


§ 13. Language Documents and correspondence relating to conformity assessment and certification shall be in the official language of the Member State where the notified body is established or in a language accepted by the body.

Chapter 4. Substantive provisions

§ 14. Basic requirements for apparatus and equipment Apparatus and equipment covered by this regulation shall comply with the basic requirements set out in Annex I. The device must also be designed for use of propane / butane and normal endorsement press 30 mbar, at least 25 mbar, maximum 35 mbar.

§ 15. The fulfillment of basic requirements The basic requirements of § 14 is considered fulfilled for apparatus and equipment when they match:

A.
National standards applicable to them, and implementing the requirements of the harmonized standard published in the Official Journal.

B.
National standards applicable to them in so far as it is not stipulated harmonized standard in the field covered by the standard and when that country has declared that the standard is consistent with the basic requirements.

§ 16. Marketing and commissioning apparatus that meets the basic requirements of § 14 and the conformity assessment procedures and certification § 9, may be freely marketed and put into operation, when it bears the CE marking according to § 11 | || equipment accompanied by a declaration of conformity as mentioned in § 10 second paragraph may be freely marketed.
Supervisory authority finds that the normal use of the apparatus equipped with CE marking can put the safety of persons, animals or property, the supervisory authority shall take all necessary measures to withdraw devices from the market or prohibit or restrict the marketing of them.

Annex I
: Basic requirements

Annex II
: Compliance and certification procedures

Appendix III
: CE marking and inscriptions

Annex IV
Construction Documentation

Annex V
Minimum criteria for the designation of Notified Body shall be notified

Appendix I. Basic requirements


Preliminary remark The obligations resulting from the essential requirements for appliances in this Annex also apply to fittings where there is a similar risk.

1.
Terms

1.1.
Appliances must be so designed and constructed that, when used normally see. Regulations § 3, works in a completely safe manner and not cause danger to persons, animals or property.

1.2.
By marketing should be with each apparatus follow one:

-
Technical guidance for the installation,

-
A user guide to the user

-
A maintenance manual for the user.

Necessary warnings should be applied both on the machine and packaging.
Instructions and warning notices must be in the official language of the Member State shall receive apparatuses, in Norway in Norwegian.

1.2.1.
The technical guidance for the installer must contain all the instructions for proper installation, adjustment, maintenance and safe operation of the appliance. The instructions shall indicate in particular:

-
Type of gas used,

-
Supply pressure used,

-
The flow of fresh air required:

A.
That supply of combustion air,

B.
To prevent the formation of dangerous unburned gas mixtures for appliances not fitted with the device referred to in paragraph. 3.2.3,

-
Conditions for derivation of combustion products,

-
For gas burners with combustion air fan and heating units to be equipped with such burners, their characteristics and the requirements which will contribute to the basic requirements for pre-assembled apparatus complied with, and possibly an overview of the combinations recommended by the manufacturer.

1.2.2.
The User's Guide to use shall contain all information necessary for safe use, and must in particular draw attention to the restrictions on use.

1.2.3.
Warnings to the unit and its packaging must clearly state the type of gas supply pressure must be used and the restrictions on use, in particular the restriction whereby the appliance must be installed where there is adequate ventilation.

1.3.
Equipment to be used in an appliance must be designed and constructed so that it properly fulfills its purpose when incorporated in accordance with the instructions for installation.

The instructions for installation, adjustment, operation and maintenance must be provided with the equipment.

2.
materials

2.1.
The materials should be suitable for the purpose and must withstand the mechanical, chemical and thermal stresses they can be assumed to be exposed.

2.2.

Material properties that are important for safety must be guaranteed by the manufacturer or supplier of the appliance.

3.
Design and production

3.1.
General

3.1.1.
Appliances must be so constructed that, in normal use can not occur no instability, distortion, breakage or wear likely to impair their safety.

3.1.2.
Condensation occurs when a device is used and / or during use must not compromise.

3.1.3.
Appliances must be so designed and constructed that the risk of explosion by fire outside aid, it is the lowest.

3.1.4.
Appliances must be so constructed that water and inappropriate air penetration into the gas circuit.

3.1.5.
At normal variations in the supply of auxiliary energy unit must continue to operate safely.

3.1.6.
Abnormal fluctuation or failure of auxiliary energy or its restoration must not pose a danger.

3.1.7.
Appliances must be so designed and constructed that hazards of electrical origin preventable. This requirement shall be deemed met if the objectives set out in regulations of 7 December 1990 no. 958 on execution and control of electrical equipment offered or sold for use in low voltage, and the Regulation of 1 July 1994 no. 670 on scope and detailed rules and transitional provisions concerning the documentation and registration of electrical equipment (Council Directive 73/23 / EEC) are met in this regulation scope.

3.1.8.
All pressurized parts of an appliance must withstand the mechanical and thermal loads they are subjected without any deformation affecting safety.

3.1.9.
Appliances must be so designed and constructed that failure of a safety, controlling or regulating device may not lead to an unsafe situation.

3.1.10.
When an appliance is equipped with safety and controlling devices must the safety devices seem not be overruled by the controlling devices.

3.1.11.
All parts of appliances which are set or adjusted at the stage of manufacture and which should not be manipulated by the user or installer must be appropriately protected.

3.1.12.
Levers and other controlling and setting devices must be clearly marked and shall bear all the necessary information so that any misuse can be avoided. The design should be such that accidental manipulation.

3.2.
Emissions of unburned gas

3.2.1.
Appliances must be so constructed that the gas leakage rate is not dangerous extent

3.2.2.
Appliances must be so constructed that gas release during ignition and re-ignition and after flame extinction is limited in order to avoid a dangerous accumulation of unburned gas in the appliance avoided.

3.2.3.
Appliances intended for indoor use shall be fitted with a special device which avoids a dangerous accumulation of unburned gas in such spaces or rooms.

The apparatus is not equipped with such a device, to be used only in areas where there is sufficient ventilation to avoid a dangerous accumulation of unburned gas.
Apparatus catering and apparatus using gas containing toxic substances shall be equipped with said device.

3.3.
ignition

Any extinguisher shall be so constructed that, when used normally happens a smooth ignition and re-ignition and that all burners are secured to misfire.

3.4.
combustion

3.4.1.
Appliances must be so constructed that, when used normally, flame stability is assured and combustion products do not contain unacceptable concentrations of substances harmful to health.

3.4.2.
Appliances must be so constructed that in normal use no accidental release of combustion products.

3.4.3.
Appliances connected to a flue for combustion products must be so constructed that in abnormal draft conditions there is no release of a dangerous amount of combustion products in that space.

3.4.4.
Independent flueless domestic heating appliances and flueless fast water heaters, be in that space does not cause a concentration of carbon monoxide which can endanger the health of the people exposed, in relation to the duration exposure can be expected to last.

3.5.
Rational energy use

Appliances must be so constructed as to ensure rational use of energy corresponding to the technological level, while taking into account safety.

3.6.
temperatures

3.6.1.
Machine components to be placed close to the floor or other surfaces must not be so hot that they are a danger to the environment.

3.6.2.
Controls and regulation handle must not be so hot that they are a danger to the user.

3.6.3.

Surface temperatures of external parts of appliances intended for domestic use, with the exception of surfaces or parts which are used for heat transfer, under operating conditions present a danger to the user, especially for children, and must be taken into proper consideration to children's reaction.

3.7.
Foodstuffs and water used for sanitary purposes

When a unit may come into contact with food or water used for sanitary purposes, must materials and components used in the production of the device, not impair the foodstuff or water quality.

Appendix II. Compliance and certification procedures

1.
EC type-examination

1.1.
EC type-examination is the procedure whereby a notified body assesses whether an appliance, representative of the production envisaged, complies with the provisions of this Directive which apply to the device.

1.2.
application for EC type-examination shall be submitted by the manufacturer or authorized representative established within the European Economic Area and only one Notified Body.

1.2.1.
application shall contain:

-
Manufacturer's name and address and also the representative's name and address if the application is submitted by the representative,

-
A written declaration that the application has not been lodged with another notified body,

-
Design documentation, as specified in Annex IV.

1.2.2.
The manufacturer shall provide an appliance, representative of the production envisaged, hereinafter called 'type', 'available to the notified body. The notified body may request further samples of the aforementioned "type", if it is necessary for the test program.

A "type" may also include other varieties of the product, provided that the variations do not have different characteristics with respect to hazards.

1.3.
The notified body shall:

1.3.1.
examine the design documentation and assess whether the "type" is produced in accordance with this documentation, and specify the parts which are designed in accordance with the provisions on standards in regulations § 15 and with the basic requirements of this Directive which applies, see Annex 1. | ||
1.3.2.
make or ensure that it is made necessary examinations and / or tests to assess whether the solutions adopted by the manufacturer meet the essential requirements when the standards referred to in Regulations § 15 have not been applied,

1.3.3.
make or ensure that it is made necessary examinations and / or tests to assess whether the standards applicable, have actually been applied where the manufacturer has chosen to use them in this way to ensure compliance with the basic requirements.

1.4.
When the "type" meets the provisions of this regulation shall the notified body must issue an EC type examination certificate to the applicant. The certificate must contain conclusions of the examination, any conditions for its validity, the necessary data for identification of the 'type', which the certificate was granted and if necessary a description of its operation. Relevant technical descriptions, such as drawings and diagrams must be annexed to the certificate.

1.5.
The notified body shall immediately inform the other notified bodies issuing of the EC type examination certificate and about addition, as mentioned in point. 1.7. Bodies may obtain a copy of the EC type examination certificate and / or additions, and by justified request a copy of the Annexes to the certificate and the reports on the examinations and tests.

1.6.
A notified body which refuses to issue the EC type examination certificate, or who pulls it back, shall notify the land designated body and the other notified bodies about this and give reasons for its decision.

1.7.
applicant shall keep the notified body that issued the EC certificate informed of any changes regarding the 'type', for which the certificate is issued, which may affect the fulfillment of the basic requirements.

Changes regarding the 'type', which the certificate was granted shall be subject to an additional assessment of the notified body that issued the EC type examination certificate wherever the changes have an impact on the fulfillment of the basic requirements or conditions for use of the instrument. The new conformity assessment shall take the form of an addition to the original EC type examination certificate.

2.
EC declaration of conformity to type

2.1.

EC declaration of conformity to type is that part of the procedure whereby the manufacturer declares that the mentioned appliances correspond to the "type" as described in the EC-type examination certificate and meet the basic requirements of the Directive which apply to them. The manufacturer or his representative within the EEA shall affix the CE marking on each appliance and draw up a written declaration of conformity. The declaration of conformity may cover one or more appliances and must be kept by the manufacturer. The CE marking shall be accompanied by the identification number of the notified body responsible for the random checks referred to in section. 2.3.

2.2.
The manufacturer shall take all measures necessary so that the manufacturing process, including final product inspection and tests, ensuring that the products are uniform and that there is a correlation between components and the "type", as described in the EC type examination certificate and with the essential requirements of this Directive which shall apply. A notified body chosen by the manufacturer shall take random checks of devices as described in subsection. 2.3.

2.3.
The notified body shall carry out random checks "on the spot" by the apparatus at intervals of one year or less. An adequate number of appliances must be examined and shall be carried out necessary tests as specified in the applicable standards and mentioned in the Regulations § 15, or equivalent tests to ensure apparatus conformity with the basic requirements of the Directive. The notified body shall in each case determine whether it is necessary to make all or only some of the tests. If one or more appliances are not accepted, the notified body must take appropriate measures to prevent the marketing of them.

3.
EC declaration of conformity to type (assurance of production)

3.1.
EC declaration of conformity to type (assurance of production quality) is the procedure whereby the manufacturer who fulfills the obligations in point. 3.2 declares that the appliances are in conformity with the "type", as described in the EC type examination certificate and satisfy the basic requirements of this Directive which apply. The manufacturer or his representative within the Community must affix the CE marking on each appliance and draw up a declaration of conformity. This declaration may cover one or more appliances and must be kept by the manufacturer. The CE marking shall be accompanied by the identification number of the notified body responsible for EC surveillance.

3.2.
The manufacturer shall apply a quality system that ensures conformity of the appliances and the "type", as described in the EC type examination certificate and with the essential requirements of this Directive which apply to it. The manufacturer is subject to EC surveillance as specified in clause. 3.4.

3.3.
Quality assurance system

3.3.1.
For evaluation of the manufacturer's quality assurance system, the appliances, the necessary documentation with a notified body of his choice.

The submitted documentation shall include:

-
Quality system documentation,

-
Undertaking to fulfill the obligations arising from the quality assurance system that may be accepted by the notified body,

-
Guarantee that the quality assurance system that may be accepted by the notified body will be maintained so that it remains adequate and efficient

-
Documentation of the 'type' as EC type examination certificate is issued and a copy of the EC type examination certificate.

3.3.2.
In addition, all conditions, requirements and provisions adopted by the manufacturer into account, stated in a systematic and orderly documentation of measures, procedures and written instructions. This quality system documentation must make it possible to interpret in a uniform manner the programs, plans, manuals and quality records. Must include in particular an adequate description of:

-
Quality objectives, the organizational structure and responsibilities of management and authority with regard to appliance quality,

-
Manufacturing processes, quality control and quality assurance and systematic action programs that will be implemented,

-
Examinations and tests that will be carried out before, during and after manufacture and the frequency of tests and trials,

-
Methods to verify that the required quality, actually achieved and that the quality system is working effectively.

3.3.3.
The notified body shall examine and evaluate the quality system to determine whether it meets the requirements in section. 3.3.2. The body must presume compliance with these requirements in respect of quality systems that implement the corresponding harmonized standards.


It must notify the manufacturer of its decision and give notice to the other notified bodies. The notification to the manufacturer must contain the conclusions of the examination, the notified body's name and address as well as a justification for the notified body's assessment of the quality management system around the appliances.

3.3.4.
The manufacturer shall keep the notified body that has the quality assurance system informed of any necessary adaptation of the system, for example. as a result of new technology and quality requirements.

The notified body must examine the proposed changes and decide whether the amended quality system satisfies the relevant provisions or whether a reassessment is required. It must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the reasoned assessment of the notified body's decisions.

3.3.5.
A notified body which withdraws approval of a quality system must inform the other notified bodies and give reasons for the decision.

3.4.
EC surveillance

3.4.1.
The purpose of EC surveillance is to ensure that the manufacturer duly fulfills the obligations arising out of the quality assurance system that the manufacturer has undertaken to follow, according to the notified body's decisions.

3.4.2.
The manufacturer shall for inspection purposes allow the notified body access to the places where production, inspection, testing and storage and must provide that body access to the necessary information, in particular:

-
Documentation of quality assurance system,

-
Records as regards quality, for example. inspection reports and test data, calibration data, information on the personnel concerned, qualifications etc.

3.4.3.
The notified body shall at least once every two years audit or verification to ensure that the manufacturer's quality assurance system conforms to the quality assurance system which has previously been assessed by the notified body. The notified bodies shall, upon inspection activities deliver a report to the manufacturer.

3.4.4.
Moreover, the notified body may pay unannounced visits to the manufacturer. During such visits the body may or ensure that it is carried out tests on appliances. It must supply a report of the visit to the manufacturer and possibly a report on the tests.

3.4.5.
The manufacturer shall, upon request disclose to the notified body's report.

4.
EC declaration of conformity to type (product quality assurance)

4.1.
EC declaration of conformity to type (product quality assurance) is the procedure whereby the manufacturer who fulfills the obligations in point. 4.2 declares that the appliances are in conformity with the "type" as described in the EC-type examination certificate and meet the basic requirements of this Directive which apply to them. The manufacturer or his representative within the Community must affix the CE mark to each appliance and draw up a written declaration of conformity. This declaration may cover one or more appliances and must be kept by the manufacturer. The CE marking shall be followed by the identification number of the notified body responsible for EC surveillance.

4.2.
The manufacturer shall operate a quality system, as defined in section 4.3.. assessed by a Notified Body, and that is subject to EC surveillance as specified in clause. 4.4. upon final inspection of the appliances and by trial.

4.3.
Quality assurance system

4.3.1.
For evaluation of the manufacturer's quality assurance system should necessary documentation with a notified body of his choice.

The submitted documentation shall include:

-
Quality system documentation,

-
Undertaking to fulfill the obligations arising from the quality assurance system that may be accepted by the notified body,

-
Guarantee that the quality assurance system that may be accepted by the notified body will be maintained so that it remains adequate and efficient

-
Documentation for the 'type' as EC type examination certificate is issued and a copy of the EC type examination certificate.

4.3.2.
As part of the quality assurance system, each appliance is examined and appropriate tests as set out in applicable standards, ref. Regulations § 15 shall be undertaken, or equivalent tests shall be conducted to assess whether the device complies with the essential requirements of this Directive which apply to it.


All the elements, requirements and provisions adopted by the manufacturer into consideration shall be given in a systematic and orderly documentation of measures, procedures and written instructions. This quality system documentation must make it possible to interpret in a uniform manner the programs, plans, manuals and quality records.
Quality system documentation must contain in particular an adequate description of:

-
Quality objectives, the organizational structure and responsibilities of management and authority with regard to appliance quality,

-
Examinations and tests to be carried out after manufacture,

-
Methods to assess the quality management system is working effectively.

4.3.3.
The notified body shall examine and evaluate the quality system to determine whether it meets the requirements in section. 4.3.2. The body must presume compliance with these requirements in respect of quality systems that implement the corresponding harmonized standards. It must notify the manufacturer of its decision and give notice to the other notified bodies. The notification to the manufacturer must contain the conclusions of the examination, the name and address of the notified body and the reasoned assessment of that apparatus.

4.3.4.
The manufacturer shall keep the notified body that has the quality assurance system informed of any necessary adaptation of the system, for example as a result of new technology and quality requirements.

The notified body must examine the proposed changes and decide whether the amended quality system satisfies the relevant provisions or whether a reassessment is required. It must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the reasoned assessment decision.

4.3.5.
A notified body which withdraws approval of a quality system must inform the other notified bodies and give reasons for the decision.

4.4.
EC surveillance

4.4.1.
The purpose of EC surveillance is to ensure that the manufacturer duly fulfills the obligations arising out of the quality assurance system that the manufacturer has undertaken to follow.

4.4.2.
The manufacturer shall for inspection purposes allow the notified body access to the places where the inspection, testing and storage and must provide that body access to the necessary information, in particular:

-
Documentation of quality assurance system,

-
Records as regards quality, for example. inspection reports and test data, calibration data, information on the personnel concerned, qualifications etc.

4.4.3.
The notified body shall at least once every two years audit or verification to ensure that the manufacturer's quality assurance system conforms to the quality assurance system which has previously been assessed by the notified body. The notified bodies shall, upon inspection activities deliver a report to the manufacturer.

4.4.4.
Moreover, the notified body may pay unannounced visits to the manufacturer. During such visits the body may or ensure that it is carried out tests on appliances. It must supply a report of the visit to the manufacturer and possibly a report on the tests.

4.4.5.
The manufacturer shall, upon request disclose to the notified body's report.

5.
EC verification

5.1.
EC verification is the procedure whereby the manufacturer or his representative within the EEA ensures and declares that the appliances provisions of paragraph 3 have been applied, in accordance with the "type", as described in the EC type examination certificate and satisfy the requirements of this Directive which apply.

5.2.
The manufacturer shall take all measures necessary so that the manufacturing process ensures conformity of appliances with the "type" as described in the EC type examination certificate and with the requirements of this Directive which apply to it. The manufacturer or his representative within the Community must affix the CE mark to each appliance and draw up a written declaration of conformity. The declaration of conformity may cover one or more appliances and must be kept by the manufacturer or his representative within the EEA.

5.3.
The notified body shall conduct the necessary examinations and tests to verify that the unit complies with the requirements of the regulations, either by examination and testing of each appliance as specified in Clause 5.4 or by examination and testing of appliances on a statistical basis, as specified in section 5.5 chosen by the manufacturer.

5.4
Verification by examination and testing of every appliance


5.4.1.
All equipment must be examined individually, and shall be carried out tests as specified in the relevant standards referred to in § 15, or equivalent test to verify that the unit complies with the "type" as described in the EC type examination certificate and with the requirements of this Directive which apply.

5.4.2.
The notified body shall affix, or cause to get fitted each apparatus, which complies with the requirements, with its identification number and draw up a written conformity assessment in connection with the samples taken. The conformity assessment may cover one or more appliances.

5.4.3.
The manufacturer or his representative shall upon request be able to provide the notified body's conformity assessment

5.5.
Statistics verification

5.5.1.
The manufacturer must present the appliances in homogeneous batches and take all necessary measures so that the manufacturing process ensures each manufactured batch is uniform.

5.5.2.
The statistical method comprising the following elements:

Devices should be subjected to statistical control on the basis of features. The devices should be divided into identifiable batches comprising sets of a single model manufactured under the same conditions with random intervals should a party be examined. The appliances constituting selection sample are examined individually, and it will be implemented appropriate tests defined in the or the applicable standards, ref. § 15, or equivalent tests, to determine whether that portion shall be accepted or not.
It shall apply a sampling program following criteria:

-
A standard quality level corresponding to a 95% probability of acceptance with a percentage of non-conformity between 0,5 and 1,5%,

-
A limit quality corresponding to 5% probability of acceptance with a percentage of non-conformity between 5 and 10%.

5.5.3.
The notified body shall affix, or cause to get fitted every appliance in a party, which is in accordance with the requirements of this regulation, with its identification number and draw up a written conformity assessment in connection with the tests conducted. All appliances in the batch may be marketed with the exception of the instruments from the sample portion which was not found to be in compliance.

If a batch is found to be in compliance with requirements, the notified body shall take all necessary measures to prevent it from being marketed. If parties rejected frequently, the notified body may suspend the scheme statistical verification.
During the manufacturing process, the manufacturer of the notified body responsible inflict thereof identification number on the product.

5.5.4.
The manufacturer or his representative shall, at the request could present the notified body's conformity assessment.

6.
EC verification of devices

6.1.
EC verification by unit is the procedure whereby the manufacturer or his representative within the EEA ensures and declares that the apparatus certificate referred to in Section 6.2 is issued, correspond to the requirements of this Directive which apply to it.

Manufacturer or his representative within the Community must affix the CE marking to the appliance and draw up a written declaration of conformity which he must keep.

6.2.
The notified body must examine the appliance and carry out the necessary tests while taking into account the construction documentation ref. Annex IV, to ensure that it complies with the basic requirements of the Directive.

The notified body shall affix, or cause to get supply each apparatus, which complies with the requirements, with its identification number and draw up a written conformity assessment in connection with the samples taken.

6.3.
Construction documentation ref. Annex IV aims to make it possible to assess whether the requirements of this regulation are met and to understand how the appliance is designed, manufactured and works.

Construction documentation shall be made available to the notified body.

6.4.
If the notified body deems it necessary, the appropriate examinations and tests carried out after the appliance is installed.

6.5.
The manufacturer or his representative shall, upon request, disclose to the notified body's conformity assessment.

Appendix III. CE marking and inscriptions

1.
CE marking shall consist of the initials CE taking the following form:

CE marking shall be followed by the identification number of the notified body involved in the production evaluation phase.

2.
CE marking shall be applied to the device or its nameplate together with the following inscriptions:


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Manufacturer's name or identification symbol

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Appliance trade designation,

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Possibly the type of power used,

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Apparatus category,

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The last two digits of the year in which the CE marking was affixed.

Information necessary for installation must be added, depending on the device type.

3.
If the CE marking is reduced or enlarged shall ratios as noted above drawing is held.

The various components of the CE marking consists of going as far as possible be the same height and not be less than 5 mm.

Annex IV. Construction documentation

Construction documentation shall include the following information, to the extent notified bodies need them in the assessment:

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A general description of the appliance,

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Construction principles, manufacturing drawings, lists of parts, assembly parts, circuits, etc.,

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Descriptions and explanations necessary to understand the particulars listed above, including apparatus the functioning,

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An overview of the standards mentioned in regulation § 15 that completely or partially applicable, and a description of the solutions adopted to fulfill the essential requirements when the standards referred to in § 15 have not been applied,

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Test reports,

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Manuals for installation and use.

Optionally the design documentation must contain the following elements:

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Testimonials for equipment built into the appliance

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Attestations and certificates relating to the methods of manufacture and / or inspection and / or monitoring of the appliance,

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Any other documents that provide the notified body a better assessment.

Annex V. Minimum Criteria for designating notified bodies to be notified

The notified bodies designated by EEA countries shall meet the following minimum requirements:

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They should have sufficient staff and the necessary means and equipment,

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Staff shall have technical competence and professional integrity,

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While performing the tests, preparing reports, issuing certificates and conducting of supervision provided for in these regulations and appendices must managers and technical staff be independent of all circles, groups or individuals who directly or indirectly holds interests on the area appliances covers,

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Staff shall have confidentiality

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Liability shall be drawn unless assumed by the State in accordance with national legislation.

The competent authority or notified bodies designated by the Administration shall periodically assess whether the conditions in the first two indents are met.