- non-linear, or
- with damping of the return movement;
(e) energy-dissipating shock absorbers;
(f) safety devices fitted to jacks of hydraulic power circuits where these are used as devices to prevent falls;
(g) electric safety devices in the form of safety switches containing electronic components.
Annex VI
ASSEMBLY INSTRUCTIONS FOR PARTLY COMPLETED MACHINERY
The assembly instructions for partly completed machinery must contain a description of the conditions which must be met with a view to correct incorporation in the final machinery, so as not to compromise safety and health.
The assembly instructions must be written in an official Community language acceptable to the manufacturer of the machinery in which the partly completed machinery will be assembled, or to his authorised representative.
Annex VII
A. Technical file for machinery
This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the requirements of this Directive. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages, except for the instructions for the machinery, for which the special provisions of Annex I, section 1.7.4.1 apply.
1. The technical file shall comprise the following:
(a) a construction file including:
- a general description of the machinery,
- the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery,
- full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements,
- the documentation on risk assessment demonstrating the procedure followed, including:
(i) a list of the essential health and safety requirements which apply to the machinery,
(ii) the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery,
- the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards,
- any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative,
- a copy of the instructions for the machinery,
- where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery,
- where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery,
- a copy of the EC declaration of conformity;
(b) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of this Directive.
The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file.
2. The technical file referred to in point 1 must be made available to the competent authorities of the Member States for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced.
The technical file does not have to be located in the territory of the Community, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity.
The technical file does not have to include detailed plans or any other specific information as regards the sub-assemblies used for the manufacture of the machinery unless a knowledge of them is essential for verification of conformity with the essential health and safety requirements.
3. Failure to present the technical file in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the essential health and safety requirements.
B. Relevant technical documentation for partly
completed machinery
This part describes the procedure for compiling relevant technical documentation. The documentation must show which requirements of this Directive are applied and fulfilled. It must cover the design, manufacture and operation of the partly completed machinery to the extent necessary for the assessment of conformity with the essential health and safety requirements applied. The documentation must be compiled in one or more official Community languages.
It shall comprise the following:
(a) a construction file including:
- the overall drawing of the partly completed machinery and drawings of the control circuits,
- full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the partly completed machinery with the applied essential health and safety requirements,
- the risk assessment documentation showing the procedure followed, including:
(i) a list of the essential health and safety requirements applied and fulfilled,
(ii) the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, where appropriate, the indication of the residual risks,
(iii) the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards,
(iv) any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative,
(v) a copy of the assembly instructions for the partly completed machinery;
(b) for series manufacture, the internal measures that will be implemented to ensure that the partly completed machinery remains in conformity with the essential health and safety requirements applied.
The manufacturer must carry out necessary research and tests on components, fittings or the partly completed machinery to determine whether by its design or construction it is capable of being assembled and used safely. The relevant reports and results shall be included in the technical file.
The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to the competent authorities of the Member States. It does not have to be located in the territory of the Community, nor does it have to be permanently available in material form. It must be capable of being assembled and presented to the relevant authority by the person designated in the declaration for incorporation.
Failure to present the relevant technical documentation in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the partly completed machinery with the essential health and safety requirements applied and attested.
Annex VIII
ASSESSMENT OF CONFORMITY WITH INTERNAL CHECKS
ON THE MANUFACTURE OF MACHINERY
1. This Annex describes the procedure by which the manufacturer or his authorised representative, who carries out the obligations laid down in points 2 and 3, ensures and declares that the machinery concerned satisfies the relevant requirements of this Directive.
2. For each representative type of the series in question, the manufacturer or his authorised representative shall draw up the technical file referred to in Annex VII, part A.
3. The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured machinery with the technical file referred to in Annex VII, part A, and with the requirements of this Directive.
Annex IX
EC TYPE-EXAMINATION
EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative model of machinery referred to in Annex IV (hereafter named the type) satisfies the provisions of this Directive.
1. The manufacturer or his authorised representative must, for each type, draw up the technical file referred to in Annex VII, part A.
2. For each type, the application for an EC type-examination shall be submitted by the manufacturer or his authorised representative to a notified body of his choice.
The application shall include:
- the name and address of the manufacturer and, where appropriate, his authorised representative,
- a written declaration that the application has not been submitted to another notified body,
- the technical file.
Moreover, the applicant shall place at the disposal of the notified body a sample of the type. The notified body may ask for further samples if the test programme so requires.
3. The notified body shall:
3.1. examine the technical file, check that the type was manufactured in accordance with it and establish which elements have been designed in accordance with the relevant provisions of the standards referred to in Article 7(2), and those elements whose design is not based on the relevant provisions of those standards;
3.2. carry out or have carried out appropriate inspections, measurements and tests to ascertain whether the solutions adopted satisfy the essential health and safety requirements of this Directive, where the standards referred to in Article 7(2) were not applied;
3.3. where harmonised standards referred to in Article 7(2) were used, carry out or have carried out appropriate inspections, measurements and tests to verify that those standards were actually applied;
3.4. agree with the applicant as to the place where the check that the type was manufactured in accordance with the examined technical file and the necessary inspections, measurements and tests will be carried out.
4. If the type satisfies the provisions of this Directive, the notified body shall issue the applicant with an EC type-examination certificate. The certificate shall include the name and address of the manufacturer and his authorised representative, the data necessary for identifying the approved type, the conclusions of the examination and the conditions to which its issue may be subject.
The manufacturer and the notified body shall retain a copy of this certificate, the technical file and all relevant documents for a period of 15 years from the date of issue of the certificate.
5. If the type does not satisfy the provisions of this Directive, the notified body shall refuse to issue the applicant with an EC type-examination certificate, giving detailed reasons for its refusal. It shall inform the applicant, the other notified bodies and the which notified it. An appeal procedure must be available.
6. The applicant shall inform the notified body which retains the technical file relating to the EC type-examination certificate of all modifications to the approved type. The notified body shall examine these modifications and shall then either confirm the validity of the existing EC type-examination certificate or issue a new one if the modifications are liable to compromise conformity with the essential health and safety requirements or the intended working conditions of the type.
7. The Commission, the and the other notified bodies may, on request, obtain a copy of the EC type-examination certificates. On reasoned request, the Commission and the may obtain a copy of the technical file and the results of the examinations carried out by the notified body.
8. Files and correspondence referring to the EC type-examination procedures shall be written in the official Community language(s) of the where the notified body is established or in any other official Community language acceptable to the notified body.
9. Validity of the EC type-examination certificate
9.1. The notified body has the ongoing responsibility of ensuring that the EC type-examination certificate remains valid. It shall inform the manufacturer of any major changes which would have an implication on the validity of the certificate. The notified body shall withdraw certificates which are no longer valid.
9.2. The manufacturer of the machinery concerned has the ongoing responsibility of ensuring that the said machinery meets the corresponding state of the art.
9.3. The manufacturer shall request from the notified body the review of the validity of the EC type-examination certificate every five years.
If the notified body finds that the certificate remains valid, taking into account the state of the art, it shall renew the certificate for a further five years.
The manufacturer and the notified body shall retain a copy of this certificate, of the technical file and of all the relevant documents for a period of 15 years from the date of issue of the certificate.
9.4. In the event that the validity of the EC-type examination certificate is not renewed, the manufacturer shall cease the placing on the market of the machinery concerned.
Annex X
FULL QUALITY ASSURANCE
This Annex describes the conformity assessment of machinery referred to in Annex IV, manufactured using a full quality assurance system, and the procedure whereby a notified body assesses and approves the quality system and monitors its application.
1. The manufacturer must operate an approved quality system for design, manufacture, final inspection and testing, as specified in point 2, and shall be subject to the surveillance referred to in point 3.
2. Quality system
2.1. The manufacturer or his authorised representative shall lodge an application for assessment of his quality system to a notified body of his choice.
The application shall contain:
- the name and address of the manufacturer and, where appropriate, his authorised representative,
- the places of design, manufacture, inspection, testing and storage of the machinery,
- the technical file described in Annex VII, Part A, for one model of each category of machinery referred to in Annex IV which he intends to manufacture,
- the documentation on the quality system,
- a written declaration that the application has not been submitted to another notified body.
2.2. The quality system must ensure conformity of the machinery with the provisions of this Directive. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner, in the form of measures, procedures and written instructions. The documentation on the quality system must permit a uniform interpretation of the procedural and quality measures, such as quality programmes, plans, manuals and records.
It must contain, in particular, an adequate description of:
- the quality objectives, the organisational structure, and the responsibilities and powers of the management with regard to the design and quality of the machinery,
- the technical design specifications, including standards that will be applied and, where the standards referred to in Article 7(2) are not applied in full, the means that will be used to ensure that the essential health and safety requirements of this Directive are fulfilled,
- the design inspection and design verification techniques, processes and systematic actions that will be used when designing machinery covered by this Directive,
- the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,
- the inspections and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
- the quality records, such as inspection reports and test data, calibration data, and reports on the qualifications of the personnel concerned,
- the means of monitoring the achievement of the required design and quality of the machinery, as well as the effective operation of the quality system.
2.3. The notified body shall assess the quality system to determine whether it satisfies the requirements of point 2.2.
The elements of the quality system which conform to the relevant harmonised standard shall be presumed to conform to the corresponding requirements referred to in point 2.2.
The team of auditors must have at least one member who is experienced in the assessment of the technology of the machinery. The assessment procedure shall include an inspection to be carried out at the manufacturer's premises. During the assessment, the team of auditors shall carry out a review of the technical files referred to in point 2.1, second paragraph, third indent to ensure their compliance with the relevant health and safety requirements.
The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. An appeal procedure must be available.
2.4. The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to ensure that it remains appropriate and effective.
The manufacturer or his authorised representative shall inform the notified body which approved the quality system of any planned change to it.
The notified body shall evaluate the proposed changes and decide whether the modified quality assurance system will continue to satisfy the requirements referred to in point 2.2, or whether a re-assessment is necessary.
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
3. Surveillance under the responsibility of the notified body
3.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
3.2. The manufacturer shall, for inspection purposes, allow the notified body access to the places of design, manufacture, inspection, testing and storage, and shall provide it with all necessary information, such as:
- the documentation concerning the quality system,
- the quality records provided for in that part of the quality system concerned with design, such as the results of analyses, calculations, tests, etc.,
- the quality records provided for in that part of the quality system concerned with manufacture, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.
3.3. The notified body shall conduct periodic audits to make sure that the manufacturer is maintaining and applying the quality system; it shall provide the manufacturer with an audit report. The frequency of the periodic audits shall be such that a full reassessment is carried out every three years.
3.4. Moreover, the notified body may pay the manufacturer unannounced visits. The need for these additional visits and their frequency will be determined on the basis of a visit monitoring system managed by the notified body. In particular, the following factors will be taken into account in the visits monitoring system:
- the results of previous surveillance visits,
- the need to monitor remedial measures,
- where appropriate, special conditions attaching to approval of the system,
- significant modifications in the organisation of the manufacturing process, measures or techniques.
On the occasion of such visits, the notified body may, if necessary, carry out tests or have them carried out in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if a test was carried out, with a test report.
4. The manufacturer or his authorised representative shall keep available for the national authorities, for a period of ten years from the last date of manufacture:
- the documentation referred to in point 2.1,
- the decisions and reports of the notified body referred to in point 2.4, third and fourth subparagraphs, and in points 3.3 and 3.4.
Annex XI
MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER
STATES FOR THE NOTIFICATION OF BODIES
1. The body, its director and the staff responsible for carrying out the verification tests shall not be the designer, manufacturer, supplier or installer of machines which they inspect, nor the authorised representative of any of these parties. They shall not become involved, either directly or as authorised representatives, in the design, construction, marketing or maintenance of the machines. This does not preclude the possibility of exchanges of technical information between the manufacturer and the body.
2. The body and its staff shall carry out the verification tests with the highest degree of professional integrity and technical competence and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of the inspection, especially from persons or groups of persons with an interest in the result of verifications.
3. For each category of machinery for which it is notified, the body must possess personnel with technical knowledge and sufficient and appropriate experience to perform a conformity assessment. It must have the means necessary to complete the technical and administrative tasks connected with implementation of the checks in an appropriate manner; it must also have access to the equipment necessary for the exceptional checks.
4. The staff responsible for inspection shall have:
- sound technical and vocational training,
- satisfactory knowledge of the requirements of the tests they carry out and adequate experience of such tests,
- the ability to draw up the certificates, records and reports required to authenticate the performance of the tests.
5. The impartiality of inspection staff shall be guaranteed. Their remuneration shall not depend on the number of tests carried out or on the results of such tests.
6. The body shall take out liability insurance unless its liability is assumed by the State in accordance with national law, or the itself is directly responsible for the tests.
7. The staff of the body shall be bound to observe professional secrecy with regard to all information obtained in carrying out its tasks (except vis-a-vis the competent administrative authorities of the State in which its activities are carried out) under this Directive or any provision of national law giving effect to it.
8. Notified bodies shall participate in coordination activities. They shall also take part directly or be represented in European standardisation, or ensure that they know the situation in respect of relevant standards.
9. Member States may take all necessary measures they regard as necessary in order to ensure that, in the event of cessation of the activities of a notified body, the files of its customers are sent to another body or are made available to the which has notified it.
Annex XII
