Changes from prior edition of B11.0

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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