Last edit: 22/07/2023
This new edition includes updates / content in the following areas:
- clarified text related to responsibilities of machinery suppliers, users, modifiers, purchasers of used machinery, and other entities;
- introduced concepts of co-manufacturer(s) and their associated responsibilities;
- updated and clarified responsibilities for existing (legacy) machinery;
- included requirements for when whole body access situations exist and/or apply;
- improved the information about validation;
- improved information related to remote / tele–operations of machinery;
- expanded requirements for radiation hazards and associated risk reduction measures;
- added a new section for heated systems and related equipment for processing of materials;
- updated requirements for Information for Use and manuals, consistent with ISO 20607;
- reorganized clauses 4 (Responsibilities) and 5 (Lifecycle Requirements);
- added new definitions and updated existing ones, like, for example recognizing distinctions between, and characterizing energy as hazardous, non-hazardous, or beneficial;
- clarified content of Table D1 on estimating severity of harm;
- added a new annex on Control Devices.
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