Pilz offers the following summary of the main changes in Machinery Directive 2006/42/EC.
There are numerous changes, but some of the key points are summarised below:
Process of Risk Assessment
Machine manufacturers are obligated to complete a Risk Assessment, which is now defined within the Directive as an iterative process of hazard identification, risk estimation, hazard elimination or risk reduction.
Safety system requirements
Machine designers are obligated to design control systems in such a way that a fault in the hardware or software of the control system and/or reasonably foreseeable human error does not lead to hazardous situations.
Administrative and assessment procedures
New assessment procedures are defined for machines listed in Annex IV of the Directive and for partly completed machines. For manufacturers of Annex IV machines, self-certification is now possible.
Machine builders outside the EU
Machine builders outside the EU must authorise a person who must be established in the Community to compile the technical file for the machine. Machine builders without an operation in the EU can appoint an authorised representative.
Supporting harmonised standards
The supporting standard governing the design and implementation of the safety-related parts of control systems on machinery (EN 954-1) is also to be withdrawn. Machine builders should therefore refer to EN ISO 13849 or EN/IEC 62061 to achieve compliance with the new Directive. [See this more recent announcement confirming the extended transition period for EN 954-1 - Ed]