Comparison of Legal Requirements: The Machinery Directive vs. the Machinery Regulation
1.1.2. Principles of safety integration
Changes
- The scope is expanded to also include related products
- The concept of hazard sources is introduced and partially replaces risks
- Elimination of hazard sources is prioritized over minimization
- Requirements are addressed solely to the manufacturer (authorized representative removed)
- The concept of protective measures is clarified and used consistently
- New requirement: safety functions shall be testable
- New requirement: test procedures shall be specified
- The requirement is changed from "supplied together with" to "be provided with" equipment and accessories.
Proposed measures
- Ensure that the risk assessment identifies and addresses "risk sources" (not just risks) at all stages of design and manufacture
- Ensure that the design process is documented as prioritising elimination of risk sources over minimisation
- Verify that all protective measures are clearly defined, traceable, and linked to identified risk sources
- Ensure that responsibility for compliance is clearly established with the manufacturer (not delegated to an authorised representative)
- Check that all safety functions are designed so that they can be tested (practically testable)
- Verify that defined and documented procedures exist for testing safety functions
- Ensure that instructions for testing safety functions are included in the instructions for use where required
- Check that the machine is equipped with all necessary equipment and accessories for safe setting, maintenance, use, and testing
- Verify that any test equipment or special tools required for safe functional testing are supplied or specified
Machinery Directive statutory text
1.1.2. Principles of safety integration
(a) Machinery must be designed and constructed so that it is fitted for its function, and can be operated, adjusted and maintained without putting persons at risk when these operations are carried out under the conditions foreseen but also taking into account any reasonably foreseeable misuse thereof.
The aim of measures taken must be to eliminate any risk throughout the foreseeable lifetime of the machinery including the phases of transport, assembly, dismantling, disabling and scrapping.
(b) In selecting the most appropriate methods, the manufacturer or his authorised representative must apply the following principles, in the order given:
— eliminate or reduce risks as far as possible (inherently safe machinery design and construction),
— take the necessary protective measures in relation to risks that cannot be eliminated,
— inform users of the residual risks due to any shortcomings of the protective measures adopted, indicate whether any particular training is required and specify any need to provide personal protective equipment.
(c) When designing and constructing machinery and when drafting the instructions, the manufacturer or his authorised representative must envisage not only the intended use of the machinery but also any reasonably foreseeable misuse thereof.
The machinery must be designed and constructed in such a way as to prevent abnormal use if such use would engender a risk. Where appropriate, the instructions must draw the user's attention to ways — which experience has shown might occur — in which the machinery should not be used.
(d) Machinery must be designed and constructed to take account of the constraints to which the operator is subject as a result of the necessary or foreseeable use of personal protective equipment.
(e) Machinery must be supplied with all the special equipment and accessories essential to enable it to be adjusted, maintained and used safely.
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Machinery Regulation legal text
1.1.2. Principles of safety integration
(a) Machinery or related products shall be designed and constructed so that they are fit for their function, and can be operated, adjusted and maintained without putting persons at risk when these operations are carried out under the conditions foreseen but also taking into account any reasonably foreseeable misuse thereof. The aim of protective measures shall be to eliminate any risk throughout the foreseeable lifetime of the machinery or related product including the phases of transport, assembly, dismantling, disabling and scrapping.
(b) In selecting the most appropriate methods, the manufacturer shall apply the following principles, in the order given:
(i) eliminate hazards or, if that is not possible, minimise risks (inherently safe machinery or related product design and construction);
(ii) take the necessary protective measures in relation to risks that cannot be eliminated;
(iii) inform users of the residual risks due to any shortcomings of the protective measures adopted, indicate whether any particular training is required and specify any need to provide personal protective equipment.
(c) When designing and constructing machinery or a related product and when drafting the instructions for use, the manufacturer shall envisage not only the intended use of the machinery or related product but also any reasonably foreseeable misuse thereof. The machinery or related product shall be designed and constructed in such a way as to prevent abnormal use if such use would engender a risk. Where appropriate, the instructions for use shall draw the user’s attention to ways – which experience has shown might occur – in which the machinery or related product should not be used.
(d) Machinery or related products shall be designed and constructed to take account of the constraints to which the operator is subject as a result of the necessary or foreseeable use of personal protective equipment.
(e) Machinery or related products shall be designed and constructed in such a way that it is possible for the user, where applicable, to test the safety functions. The machinery or related product shall be supplied with all the special equipment and accessories, and where appropriate, with the description of specific functional test procedures, essential to enable it to be tested, adjusted, maintained and used safely.
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