Sterilization of health care products -- Radiation -- Part 1: Requirements For development, validation and routine control of a sterilization process for medical devices— 44 стр.
Sterilization of health care products -- Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives -- Requirements for characterization, development, validation and routine control of a sterilization process for medical devices— 42 стр.
Cleanrooms and associated controlled environments -- Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration— 22 стр.
Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices— 48 стр.
Cleanrooms and associated controlled environments -- Biocontamination control -- Part 2: Evaluation and interpretation of biocontamination data— 16 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.
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices— 48 стр.
Sterilization of health care products -- Dry heat -- Requirements for the development, validation and routine control of a sterilization process for medical devices— 68 стр.
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); German version EN ISO 13408-7:2015— 38 стр.
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); German version FprEN ISO 13408-7:2015— 38 стр.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015— 19 стр.
