What are the minimum requirements for the content of the instructions for use?

Monday, 17 September 2018 16:49 Guidelines
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The list of minimum contents of the instructions for use given in Directive 2006/42/EC is not exhaustive. The manufacturer of the machinery should also provide other information that may be necessary. The Machinery Directive states in requirement that " each instruction manual must contain, where applicable, at least the following information ...".

The minimum information that should be included in the instructions for use should be:

1. The business name and full address of the manufacturer (and where applicable of his authorised representative).

2. The designation of the machinery as marked on the machinery itself, except for the serial number.

3. The EC declaration of conformity or a document setting out the contents of the EC declaration of conformity, showing the details of the machinery, it is not necessary for the serial number and signature to be provided.

4. A general description of the machinery enabling the user to identify the main parts of the machine and their functions.

5. A description of the workstation(s) likely to be occupied by operators.

6. A description of the intended use of the machinery accompanied by warnings concerning ways in which the machinery must not be used that experience has shown might occur.

7. Information about the residual risks that remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted.

8. Instruction to carry out without any risk:

- assembly, installation and connection instructions, including drawings, diagrams and the means of attachment and the designation of the chassis or installation on which the machinery is to be mounted

- putting into service

- use

- transport, handling and storage operations can be made safely, giving the mass of the machinery and of its various parts where these are regularly to be transported separately

- dismantling when out of service, testing or foreseeable breakdowns

- adjustment

- maintenance

- if needed, the instruction for the training of the users. Operator training activities carried out by the machine manufacturer are not to be considered as additions to the operating instructions provided in accordance with the requirements of the Machinery Directive

- If needed, the essential characteristics of tools which may be fitted to the machinery

- the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided

- the conditions in which the machinery meets the requirement of stability during use, transportation, assembly

- conditions in which the machinery meets the stability requirements during use, transport, assembly, dismantling, out of service, testing or foreseeable failure;

- the operating method to be followed in the event of accident or breakdown; if a blockage is likely to occur, the operating method to be followed so as to enable the equipment to be safely unblocked

9. Specifications of the spare parts to be used, when these affect the health and safety of operators.

10. Where machinery is likely to emit non-ionising radiation which may cause harm to persons, in particular persons with active or non-active implantable medical devices, information concerning the radiation emitted for the operator and exposed persons.

11. Instructions relating to installation and assembly for reducing noise or vibration (like in letter u of requirement

12. The airborne noise level emitted by the machine.

With these requirements in mind, there are texts that can be useful for defining the content of the operating instructions, such as EN ISO 12100:2010.

Information on the content of the operating instructions can also be found in the type C standards for specific machines.

3281 Monday, 23 March 2020 17:06

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