Medical devices -- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices— 24 стр.
Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems— 29 стр.
Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices— 46 стр.
