Key Benefits:
Decision of 8 January 1992 concerning the safety and use of gas appliances and their accessories
We Beatrix, at the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc. etc. etc.
On the nomination of the Secretary of State for Welfare, Health and Culture of 13 November 1991, VVP/P-U-692116, made on behalf of our Minister for Economic Affairs;
Whereas, having regard to Directive 90 /396/EEC of the Council of the European Communities of 29 June 1990 on the approximation of the laws of the Member States concerning appliances burning gaseous fuels ( PbEG L 196), it is necessary to lay down rules on the safety and energy use of appliances burning gaseous fuels and their accessories;
Having regard to Article 1 (4), first paragraph, of the first subparagraph, A and B , 8, parts a, b and C , 11, 12, 13 and 14 of the Commodity law ( Stb. 1988, 360) and the Articles 2 , 3, 4, 5, 6, 7 and 21 of the Energy Conservation Act ( Stb. 1986, 59);
Having regard to the opinion of the Advisory Committee Commodity law of 18 September 1991, No 14 398/( 50) 5;
The Council of State heard (opinion of 13 December 1991, No W13.91.0595);
Having regard to the further report of the Secretary of State for Welfare, Public Health and Culture of 20 December 1991, published on behalf of our Minister for Economic Affairs, VVP/P-692577;
Have found good and understand:
1 In this Decision, the following definitions shall apply:
a. Gas: any fuel, at a temperature of 15 ° C, under a pressure of 1 bar, in a gaseous state;
b. Host appliances: appliances for cooking, heating, hot water production, refrigeration, lighting or washing products which, if applicable, have a normal water temperature of not more than 105 ° C, and fan burners and the like Heat generators referred to in burners, and for use of which gas is used as fuel;
c. accessories: protective, control and control equipment and components, excluding fan burners and heat generators intended for such burners, which are intended to be incorporated into a gas supply system or to a maximum of one guest equipment to be assembled;
d. normal use: use using gas appliances,
1. have been correctly installed and maintained in accordance with the manufacturer's instructions;
2. are used with a normal fluctuation of gas quality and gas pressure; and
3. be used in accordance with their intended purpose or in a reasonably foreseeable manner.
2 By way of derogation from paragraph 1, gas appliances shall not include gas appliances specifically intended for use in industrial processes under this Decision.
3 In this Decision, insofar as it is based on the Law implementing EU directives energy efficiency 'trading' means the sale, sale, rental or delivery of the sale, sale or sale of goods.
1 It shall be prohibited to trade appliances and accessories which do not meet the requirements of or pursuant to this Decision.
2 It shall be prohibited to trade appliances and accessories other than in compliance with the requirements laid down in or pursuant to this Decision in respect of the indication and use of particulars.
3 It shall be prohibited to trade in gas appliances other than those for which it is reserved in this Decision, using the indication indicated in this Decision.
1 Host appliances and accessories must be assembled in such a way that they have characteristics and indications that they do not constitute a special hazard to the safety of the appliances when the appliances are normally used. persons, domestic animals or goods.
2 Gas appliances and accessories must meet the requirements of Annex I basic requirements concerning the safety and efficient use of energy of appliances and accessories.
Gas appliances and accessories are suspected of complying with Article 3, second paragraph certain, if they meet the standards required by our Minister for Health, Welfare and Sport.
2 The term referred to in paragraph 1 may be used only:
a. after obtaining an EC type-examination certificate for the relevant type of gas appliances as intended for use in the product Annex III , Part A EC type-examination and, as long as the manufacture of the type of device is carried out, taking into account one of the four types in question: Annex III , Part B , those procedures relating to the manufacture of appliances burning gaseous fuels, or
b. after taking into account the Part C Of Annex III Procedure for EC verification by unit, for each gas supply unit separately.
3 Accessories may not be marked with the indication referred to in paragraph 1 but must bear a declaration issued by the manufacturer that they comply with the relevant requirements as set out in the Annex to this Regulation. Annex I and in which the characteristics of the accessories are also specified, as well as the requirements for insertion into a host apparatus or assembling thereof, which are relevant to the fulfilment of the requirements of the host apparatus in the case of or pursuant to this Decision. rules.
4 The declaration referred to in paragraph 3 may be issued only for accessories in respect of which one of the four statements in question must be issued. Annex III , Part B The procedures specified in respect of gas appliances have been complied with by analogy, with the exception of the CE marking laid down in those procedures and for which an EC type-examination certificate as referred to in Article 4 (1) of the EC Treaty has been applied. Annex III , Part A The type of examination referred to was obtained for the type of accessory concerned.
2 The inscriptions referred to in the first paragraph and the Article 5, first paragraph The indication shall be visible, easily legible and indelible on the gas supply plate, or on a sheet attached to it, in a visible, easily legible and indelible manner.
3 The plate referred to in paragraph 2 shall be so affixed that removal is not possible without clearly visible damage to it.
4 In respect of appliances burning gaseous fuels, no particulars, statements or indications shall be provided in respect of appliances which are not used for the use of appliances or for appliances or for Annex II , Under A , that designation may be confused.
1 Our Minister for Health, Welfare and Sport shall designate the institutions which:
a. competent to enter into Article 5, second paragraph, point (a) , to carry out the EC type-examination referred to;
(b) having jurisdiction to carry out samples, EC surveillance and verification as defined in the Annex, Article 5, second paragraph, points (a) and (b) , the procedures referred to.
2 For a designation as referred to in paragraph 1, eligible bodies shall meet the requirements of the Annex V specified conditions.
3 The institutions designated under the first paragraph shall be treated in the same way as those of the competent authorities of the Member States of the European Communities or of the other States party to the Agreement on the European Economic Area, in the context of the Directive 90 /396/EEC ( PbEG L 196) designated institutions.
4 Our Minister may suspend, amend or revoke a designation:
a. on the basis of the facts or circumstances of which our Minister could not reasonably have been informed in the direction of the appointment and on the ground of which he would not have given the designation;
b. on the basis of incorrect facts or circumstances supplied by the designated institution, unless the error has been or could not be disclosed to the institution;
c. if the designated institution no longer meets the requirements of Annex V specified conditions;
(d) if the designated institution has performed for a continuous period of two years in which it has been designated; or
e. if the designated institution does not properly comply with its legal obligations or does not properly carry out the tasks for which it is designated.
Appliances and accessories which do not comply with or pursuant to this Decision may continue to be marketed until 1 January 1996.
This Decision shall enter into force from the second day following the date of issue of the State Sheet where it is placed.
This decision may be referred to as: Host appliances Decision.
Burden and order that this Decision, together with the accompanying note of explanatory note to the State Sheet will be placed and copies thereof will be sent to the Council of State.
' s-Gravenhage, 8 January 1992
Beatrix
The Secretary of State for Welfare, Health and Culture,
H. J. Simons
The Minister for Economic Affairs,
J. E. Andriessen
Published the twenty-sixth March 1992The Minister of Justice,
E. M. H. Hirsch Ballin
Preliminary remark
The obligations for appliances set out in the basic requirements of this Annex shall also apply to accessories if they are related to hazards which may also occur in respect of accessories.
1.1. A device must be designed and constructed in such a way that its operation is safe and that it is defined in normal use as defined in Article 1, first paragraph, part d , poses no danger to persons, pets or goods.
1.2. When the device is placed on the market, the following shall:
-technical instructions for the installer are provided;
-instructions for use and maintenance are provided to the user,
-the necessary warnings on the apparatus, and on the packaging, shall be indicated.
The instructions and warnings shall be in the official languages of the Member State of destination.
1.2.1. The technical instructions for the installer shall include all instructions for installation, adjustment and maintenance so that these tasks can be performed correctly and the appliance can be used safely. It is also necessary to provide details of the following:
-the type of gas to be used,
-the gas pressure to be used,
-the required air-reversing,
-the supply of combustion air,
-in order to avoid the formation of mixtures with a dangerous non-incinerated gas content for appliances which are not equipped with the accessories referred to in paragraph 3.2.3,
-the procedure for the disposal of combustion products,
-heat generators for fan burners and such burners: the characteristics, assembly requirements to comply with the essential requirements applicable to the apparatus as a finished product and, where appropriate, to the list of combinations recommended by the manufacturer.
1.2.2. The user's instructions for use and maintenance shall provide all the necessary information for safe use and, in particular, to draw the attention of the user to any restrictions on use.
1.2.3. In the case of warnings on the apparatus and on the packaging, the gas pressure, gas pressure and any restrictions of use shall be clearly stated, and in particular the restriction that the device may be installed only in sufficient fused spaces.
1.3. The accessories to be used in the appliance shall be designed and constructed in such a way that it works in the correct manner according to the intended use if it is fitted in accordance with the instructions for the installation.
The instructions for installation, adjustment, operation and maintenance shall be provided with the accessories.
2.1. The materials shall be suitable for the intended use and shall withstand the mechanical, chemical and thermal conditions to which they are expected to be exposed.
2.2. The manufacturer or supplier must act as guarantor for material properties of relevance to safety.
3.1.1. The structure of the apparatus shall be such that, in normal use, there is no instability, distortion, fracture or wear which can endanger the safety.
3.1.2. Condensation in heating and/or during operation shall not affect the safety of the appliance.
3.1.3. The design and construction of the apparatus shall be such that, in the presence of fire outside the appliance, the explosion hazard is minimal.
3.1.4. The structure of the apparatus shall be such as to prevent the undesired entry of water and air into the gas pipeline.
3.1.5. In the case of a normal variation of the auxiliary energy, the apparatus shall continue to function safely.
3.1.6. Abnormal variation or failure of the auxiliary energy or its return must not lead to an unsafe situation.
3.1.7. The design and construction of the apparatus shall be such as to exclude hazards of an electrical nature. The subject matter of the Electrical engineering department , is applicable.
3.1.8. Pressure-forming parts of a device shall withstand the mechanical and thermal loads to which they are exposed without any deformation which endangering safety.
3.1.9. A device must be designed and constructed in such a way that a failure of a security, control or appointment device does not lead to an unsafe situation.
3.1.10. If an appliance is equipped with security and adjustment devices, the operation of the protective devices shall not be affected by that of the adjustment devices.
3.1.11. All components of a device which have been installed or set off in manufacture and which must be left unaffected by the user and the installer must be adequately protected.
3.1.12. The control and adjustment of the adjustment and adjustment of the adjustment and adjustment of the adjustment shall be clear and shall be provided with appropriate instructions to avoid erroneous operation. They must be designed so as to be excluded by chance.
3.2.1. A device must be constructed in such a way that the gas leak from a device is not likely to present a hazard.
3.2.2. An apparatus shall be so constructed that the amount of gas released in the case of ignition, re-ignition and after the doving of the flame is sufficiently limited to prevent a dangerous accumulation of unburnt gas in the appliance.
3.2.3. Devices intended to be used in enclosed spaces shall be fitted with a specific accessory to avoid dangerous accumulation of unburned gas in the rooms.
Appliances without such an accessory may only be used in spaces with sufficient air-reversing to avoid dangerous accumulation of unburned gas.
Appliances for large kitchens and appliances that operate on gas containing toxic components shall be equipped with such accessories.
A device must be constructed in such a way as to be used in normal use.
-the inflammation and inflammation are calm,
-overrun guaranteed.
3.4.1. An apparatus shall be so constructed that a stable flame is ensured in normal use, while the products of combustion must not contain unacceptable concentrations of substances harmful to health.
3.4.2. An apparatus shall be so constructed that, in normal use, no unforeseen combustion products are released.
3.4.3. A device connected to a combustion unit for combustion products shall be so constructed that, in the event of an abnormal haul, no combustion products are released in hazardous quantities in the relevant departure.
3.4.4. Heaters and individual heaters not connected to a combustion outlet for combustion products shall not cause a carbon monoxide concentration in the exit which is likely to result from exposure to the expected duration of exposure for the health of persons.
An apparatus must be constructed in such a way as to ensure the efficient use of energy in accordance with the state of knowledge and technology and with due regard for the safety aspects.
3.6.1. Parts of a device that are too close to the floor shall not be allowed to reach temperatures in the vicinity of the environment.
3.6.2. The surface temperature of the operator control buttons and handles intended for the user shall not reach any dangerous values for the user.
3.6.3. The surface of external parts of a household intended for domestic use, with the exception of the surfaces or parts which play a role in the transmission of heat, shall not reach temperatures which are in danger during use provide the user, and in particular for children, for whom an appropriate response time should be taken into account.
Without prejudice to other relevant legislation, the materials and components used for the construction of a device and which may come into contact with food or tap water shall be without prejudice to the quality of such equipment.
The CE marking is composed of the initials CE as shown below (Fig. 1)
(Fig. 1)
and is followed by the identification number of the designated institution, as specified in Article 7 (b) (b) , which is in one of the four procedures mentioned in Annex III , Part B , or EC verification by unit, mentioned in: Annex III , Part C , carried out, concerning the host appliances in question.
The following markings shall be affixed to the apparatus or the inscription plate:
-the name of the manufacturer or of his identification number;
-the factory mark of the appliance,
-the electrical power used, if applicable;
-the category of authorisation,
-the last two digits of the year in which the CE marking was affixed.
Additional information necessary for installation shall be added according to the nature of the different appliances.
In the case of magnification or reduction of the CE marking, the proportions of the under A (Fig. 1) Graduated images are observed.
The different parts of the 'CE' marking must have substantially the same height, which shall not be less than 5 mm.
1.1. The EC type-examination is that part of the procedure in which a designated institution as referred to in Article 7, first paragraph , or a related thereto Article 7, third paragraph The said institution shall establish and certify that a device representative of the intended production complies with the basic requirements in force in the field of production of the product concerned. Annex I of this Decision.
1.2. The application for EC type-examination shall be submitted by the manufacturer, or in the Community or in one of the States party to the Agreement on the European Economic Area, to a single Member State. institution as referred to in 1.1.
1.2.1. The application shall include:
-the name and address of the manufacturer, and of the authorised representative if the application is submitted by the latter;
-a written declaration that no application has been submitted to any other institution as referred to in 1.1;
-the draft documentation as defined by Annex IV of this Decision.
1.2.2. The manufacturer shall make available to the institution a representative machine, hereinafter referred to as 'type', which is representative of the intended production.
The institution may request more copies of the type, if necessary for the test programme.
A type may also include type variants, provided that those variants do not have different properties in terms of the types of hazard.
1.3. The setting referred to in point 1.1
1.3.1. studies the design documentation, verifies that the type has been manufactured in accordance with the design documentation, and identifies the components designed in accordance with the relevant provisions of the Article 4 of the standards and of the fundamental rules Annex I of this Decision;
1.3.2. carry out the appropriate examinations and/or tests, or have them carried out, in order to verify that the solutions adopted by the manufacturer comply with the essential requirements when the solutions adopted by the manufacturer are satisfied; Article 4 the said standards have not been applied;
1.3.3. carry out the appropriate examinations and/or tests, or have them carried out, to check whether, when the manufacturer has decided to apply the relevant standards, they have actually been applied, thereby ensuring that the guarantee is in conformity with the requirements of the Basic rules have been created.
1.4. If the type meets the essential requirements in Annex I of this Decision, the institution shall provide an EC type-examination certificate to the applicant. The certificate shall contain the conclusions of the examination as well as any conditions for its validity, the necessary data for the identification of the approved type and, where applicable, a description of its operation. The relevant technical data, such as drawings and diagrams, shall be attached to the certificate.
1.5. The other institutions referred to in 1.1 shall be governed immediately by the Article 7, first paragraph , designated institution notified of the issuance of the EC type-examination certificate for the said type and any additions as referred to in point 1.7. They shall, at their request, receive a copy of the EC type-approval certificate and/or additions and on the basis of a reasoned request, a copy of the annexes to the certificate, as well as the reports on the examinations and/or the examinations made. tests.
1.6. One due to Article 7, first paragraph Where a designated institution refuses to issue or withdraws an EC type-examination certificate, the Minister and the other institutions referred to in 1.1 shall inform them of the reasons for the decision.
1.7. The applicant shall keep the institution which has issued the EC type-examination certificate informed of any change in the approved type which may affect the conformity with the essential requirements.
For modification of the approved type, additional approval shall be granted by the institution which issued the EC type-examination certificate if such changes affect the compliance with the fundamental any requirements or conditions of use prescribed for the appliance. This additional approval shall be given in the form of a supplement to the original EC type-examination certificate.
1.1. Following this procedure, the manufacturer declares that the devices concerned are in conformity with the type described in the EC type-examination certificate as set out in Part A of this Annex and comply with the applicable fundamental requirements. rules in Annex I . The manufacturer or his authorized representative established within the Community shall affers the CE marking on each appliance and draw up a declaration of conformity.
This declaration of conformity shall relate to a single appliance or to a number of devices and shall be retained by the manufacturer. The CE marking shall be followed by the identification number of the institution referred to in point A, point 1.1 of this Annex, which shall be responsible for the samples described in paragraph 1.3 above;
1.2. The manufacturer shall take all measures necessary to ensure that the manufacturing process, including the final inspection and testing of the apparatus, ensures the homogeneity of production, and the conformity of the apparatus with the type as defined in the EC type-examination certificate and with the relevant essential requirements. An institution chosen by the manufacturer as referred to in Section A, 1.1 of this Annex shall carry out the samples of the devices described in 1.3.
1.3. The on-the-spot check of the apparatus shall be carried out by this institution at random intervals of not more than one year. A sufficient number of devices are being examined, while appropriate tests are set out as described in the Article 4 shall be carried out in order to ensure conformity with the relevant essential requirements in the case of the relevant standards, or tests similar to those referred to therein, Annex I . The institution shall determine in each individual case whether these trials shall be carried out in full or in part.
2.1. Following this procedure, the manufacturer, meeting the requirements of paragraph 2.2 above, declares that the devices concerned are in conformity with the type described in the EC type-examination certificate as set out in Part A of this Annex. and comply with the applicable fundamental requirements in Annex I . The manufacturer or his authorized representative established within the Community shall affers the CE marking on each appliance and draw up a declaration of conformity. This statement relates to a single appliance or to a number of appliances and shall be retained by the manufacturer. The CE marking shall be followed by the identification number of the institution referred to in subparagraph A (1.1), which shall be responsible for EC surveillance as referred to in point 2.4.
2.2. The manufacturer shall adequately establish a system of production quality assurance that the conformity of the devices with the type described in the EC type-examination certificate and with the relevant essential requirements ensures. The manufacturer shall be subject to EC surveillance as defined in point 2.4.
2.3. Quality Systems
2.3.1. The manufacturer shall submit an application for approval of his quality system to an institution as referred to in Section A, 1.1 of this Annex, for the devices concerned.
This application shall contain:
-documentation on the quality system,
-the undertaking that, after the adoption of the quality system, it will fulfil the obligations arising therefrom;
-the undertaking to maintain the approved quality system and to ensure its continued suitability and effectiveness;
-documentation on the approved type and a copy of the EC type-examination certificate.
2.3.2. All the principles, regulations and provisions adopted by the manufacturer shall be documented systematically and orderly in a documentation of written policies, procedures and instructions. This documentation on the quality system should ensure that the quality programmes, plans, manuals and files are interpreted in the same way by everyone. In particular, they should contain a proper description of:
-the quality objectives, the establishment plan and the responsibilities of management and their competence with regard to the quality of the appliances;
-the manufacturing processes, quality control and quality assurance techniques and systematic measures to be applied;
-the examinations and tests carried out before, during and after manufacture, and the frequency with which it will be carried out;
-the means to control the achievement of the required quality of the equipment and the effective operation of the quality system.
2.3.3. The institution shall examine and evaluate the quality system in order to verify compliance with the requirements referred to in point 2.3.2. It shall suspect compliance with these requirements in the case of quality systems where the relevant harmonised standard is applied.
It shall inform the manufacturer of its decision and shall inform the other institutions referred to in Part A, 1.1. of this Annex. The notification shall contain the conclusions of the examination, the name and address of the notified body and the reasoned assessment decision concerning the appliances concerned.
2.3.4. The manufacturer shall keep the institution which has approved the quality system informed of any adjustment to the quality system and of changes which may arise for example from new quality concepts.
The institution shall examine the proposed amendments and decide whether the quality system in its amended form fulfils the relevant requirements, or whether a new assessment is necessary.
It shall inform the manufacturer of its decision. The notification shall contain the conclusions to which the audit has conducted and the reasoned assessment decision.
2.3.5. An institution which withdraws approval of a quality system shall inform the other institutions referred to in Section A, 1.1 of this Annex, and state the reasons for its decision.
2.4. EC surveillance
2.4.1. The purpose of EC surveillance is to ensure that the manufacturer properly complies with the obligations arising out of the approved quality system.
2.4.2. The manufacturer shall grant the establishment for control purposes access to the manufacturing, inspection, testing and storage areas and shall provide it with all necessary information, in particular:
-documentation on the quality system,
-the quality files, such as inspection reports, test data, calibration data, qualification reports of the personnel concerned, etc.
2.4.3. The institution shall carry out at least once every two years a check to ensure that the manufacturer holds the approved quality system and applies it, and shall deliver a control report to the manufacturer.
2.4.4. In addition, the institution may bring unannounced visits to the manufacturer. During these visits, the institution may test the equipment or have it carried out. It shall submit a report on the visit to the manufacturer and, where appropriate, a test report.
2.4.5. The manufacturer shall be able to produce the institution's report at the request of our Minister.
3.1. Following this procedure, the manufacturer, fulfilling the obligations set out in point 3.2 above, certits that the devices in question are in conformity with the type described in the EC type-examination certificate as referred to in Section A of this Annex. and comply with the basic requirements applicable to the apparatus Annex I . The manufacturer or his authorized representative established within the Community shall affers the CE marking on each appliance and draw up a declaration of conformity. This declaration of conformity shall relate to one or more devices and shall be retained by the manufacturer. The CE marking shall be followed by the identification number of the institution referred to in subparagraph A (1.1), which shall be responsible for EC surveillance as referred to in point 3.4.
3.2. The manufacturer shall establish an approved quality system for the final inspection and testing of the devices, as defined in paragraph 3.3 above, and shall be subject to EC surveillance as defined in paragraph 3.4.
3.3. Quality system
3.3.1. For the purposes of this procedure, the manufacturer shall, for the appliances concerned, submit an application for approval of his quality system to an institution as referred to in point A, 1.1 of this Annex.
This application shall contain:
-documentation on the quality system,
-the undertaking that, after the adoption of the quality system, it will fulfil the obligations arising therefrom;
-the undertaking to maintain the approved quality system and to ensure its continued suitability and effectiveness;
-documentation relating to the approved type and a copy of the EC type-examination certificate.
3.3.2. Under the quality system, all devices will be examined and appropriate trials as defined in the system are being examined. Article 4 carried out in accordance with the applicable standard or standards, or equivalent tests to verify that they are in conformity with the relevant essential requirements of this Directive.
All the principles, regulations and provisions adopted by the manufacturer shall be documented systematically and orderly in a documentation of written policies, procedures and instructions. This quality system documentation allows for a uniform interpretation of the quality programmes, plans, manuals and dossiers.
The documentation on the quality system shall, in particular, contain a proper description of:
-the quality objectives, the establishment plan and the responsibilities of management and their competence with regard to the quality of the appliances;
-checks and tests which must be carried out after manufacture,
-the means to verify the effective functioning of the quality system.
3.3.3. The institution shall assess the quality system to verify that it complies with the provisions of paragraph 3.3.2. It shall presume conformity with these provisions to quality systems in which the relevant harmonised standard is applied. It shall inform the manufacturer of its decision and shall inform the other institutions referred to in Part A, 1.1. of this Annex. The notification shall contain the conclusions of the examination, the name and address of the notified body and the reasoned assessment decision concerning the appliances concerned.
3.3.4. The manufacturer shall keep the institution that has approved the quality system informed of any changes in the quality system to changes which may arise, for example, from new technologies and new quality concepts.
The institution shall examine the proposed amendments and decide whether the modified quality system complies with the relevant provisions. It shall inform the manufacturer of its decision. The notification shall contain the conclusions to which the audit has conducted and the reasoned assessment decision.
3.3.5. An institution which withdraws approval of a quality system shall inform the other institutions referred to in Section A, 1.1 of this Annex, and state the reasons for its decision.
3.4. EC surveillance
3.4.1. The purpose of EC surveillance is to ensure that the manufacturer properly complies with the obligations arising out of the approved quality system.
3.4.2. The manufacturer shall provide the establishment for inspection purposes with access to the manufacturing, testing and storage areas and shall provide it with all necessary information, in particular:
-documentation on the quality system,
-the quality files, such as inspection reports, test data, calibration data, qualification reports on the personnel concerned, etc.
3.4.3. The institution shall carry out a check on at least once every two years to ensure that the manufacturer holds the approved quality system and applies it and provides a control report to the manufacturer.
3.4.4. In addition, the institution may bring unannounced visits to the manufacturer. During these visits, the institution may test the equipment or have it carried out. It shall submit a report on the visit and a test report to the manufacturer.
3.4.5. The manufacturer shall be able to submit the report of the institution on request.
4.1. In accordance with this procedure, the manufacturer or his authorised representative established within the Community shall ensure that the equipment concerned is, in conformity with the type described in the EC type-examination certificate, as described in Annex I to this Regulation. A of the Annex, and comply with the relevant requirements of this Decision.
4.2. The manufacturer shall take all measures necessary to ensure that the manufacturing process ensures that the apparatus is in conformity with the type described in the EC type-examination certificate as set out in Part A of this Annex; and comply with the relevant requirements of this Decision. The manufacturer or his authorised representative established within the Community shall affers the CE marking on each appliance and draw up a declaration of conformity. The declaration of conformity may be stored on one or more apparatus and shall be retained by the manufacturer or his authorized representative established within the Community.
4.3. The institution referred to in point A (1.1) of this Annex shall carry out the necessary examinations and tests to verify that the apparatus complies with the requirements of this Decision; this shall be done at the discretion of the manufacturer. testing of each apparatus separately in accordance with paragraph 4.4, or by means of statistical monitoring and testing according to point 4.5.
4.4. Verification by checking and testing of each apparatus separately.
4.4.1. Each appliance is examined separately and subjected to the necessary tests, described in the Article 4 relevant standard (s) or equivalent testing, in order to verify that it is consistent with the type described in the EC type-examination certificate referred to in Part A of this Annex, and meets the relevant requirements of This Decision.
4.4.2. The institution shall affers or allow its identification number to be affixed to each appliance; it shall also make a declaration of conformity for the tests carried out. That declaration of conformity may apply to one or more devices.
4.4.3. The manufacturer or his authorised representative must be in a position to submit the declarations of agreement of the institution on request.
4.5. Statistical inspection.
4.5.1. The manufacturer shall offer its products in homogeneous lots and shall take all measures necessary to ensure that the manufacturing process ensures the homogeneity of each batch.
4.5.2. The statistical method shall make use of the following data:
The apparatus shall be subject to statistical assessment and shall be distributed to identifiable lots composed of specimens of a single model produced under substantially equal conditions. A batch shall be examined at random intervals. The selected appliances for the sample are examined separately and subjected to the necessary tests, as described in the Annex. Article 4 the applicable standard (s), or equivalent tests to determine whether the lot is approved or rejected.
A sampling plan shall be carried out using the following criteria:
(*) the normal quality level of the batch provided, corresponding to a 95% approval probability and a non-conformity content of 0,5% to 1,5%;
* The border quality of the lot offered, corresponding to an approval probability of 5% and a non-conformity content of 5% to 10%.
4.5.3. If a party is approved, the institution referred to in subparagraph A (1) (1.1) shall affers to each appliance its identification number or make it so; it shall also draw up a certificate of conformity for the tests carried out. All apparatus of the batch may be placed on the market, except for the products of the sample which were not in conformity with the test.
If a party is rejected, the institution shall take the necessary measures to prevent that lot from being placed on the market. In the case of frequent disapproval of the parties, the institution may suspend the statistical assessment.
During manufacture, the manufacturer may, under the responsibility of the institution, make the identification number of that institution.
4.5.4. The manufacturer or his authorised representative must be in a position to submit the declarations of agreement of the institution on request.
6.1. EC unit verification is the procedure whereby the manufacturer or his authorized representative established within the Community ensures and declares that the device for which the declaration referred to in procedure 1 has been issued complies with the relevant requirements of This Decision. The manufacturer or his corollary established within the Community shall affers the CE marking and draw up a declaration of conformity which he/she holds.
6.2. The institution referred to in point A (1.1) shall examine the apparatus and carry out the necessary tests on the basis of the design documentation in order to verify that the apparatus complies with the essential requirements in this field. Annex I .
The institution shall affers, or do so, to its identification number on the approved appliance, and shall draw up a certificate of conformity for the tests carried out.
6.3. Based on the Annex IV The design documentation referred to must be capable of assessing whether the product meets the requirements of this Decision and whether it is possible to obtain an insight into the design, manufacture and operation of the appliance.
The draft documentation described in Annex IV , shall be placed at the disposal of the institution.
6.4. If the institution considers it necessary, the necessary examinations and tests may be carried out after installation of the appliance.
6.5. The manufacturer or his authorized representative must be able to submit the declarations of conformity of the institution if requested.
The draft documentation shall include the following information, in so far as it is intended for the establishment of the Article 7, first paragraph , or one that is due to the Third paragraph of Article 7 For the purpose of the assessment, the said institution shall be:
-a general description of the apparatus,
-design and manufacturing drawings and diagrams of parts and parts of the apparatus, pipes, etc.;
-descriptions and explanations necessary for the understanding of the above, including the operation of the apparatus;
-a list of the Article 4 referred to standards that have been wholly or partially applied and descriptions of the solutions chosen to comply with the fundamental regulations, when the in Article 4 the said standards have not been applied;
-assessment reports;
-the manuals for installation and use.
Where appropriate, the draft documentation shall include the following information:
-the declarations concerning the equipment used in the appliance,
-the declarations and certificates relating to methods of manufacture and/or inspection and/or control of the appliance,
-all other documents which may contribute to a better evaluation by the designated authority.
The eligible institutions must meet the following conditions:
-availability of personnel, and the necessary resources and equipment;
-technical competence and professional integrity of personnel,
-independence in the conduct of tests, the drawing up of reports, the issuing of certificates and the exercise of the supervision required by this Decision, of the managerial staff and the technical staff, to all circles, groups and persons who have direct or indirect interests in the field of equipment;
-the retention of professional secrecy by the staff;
-closure of an insurance of civil liability, unless it is already covered by the State under national law.
