Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices -- Amendment 1— 10 стр.
Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems -- Amendment 1— 16 стр.
Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes -- Amendment 1— 8 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.
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.
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.
Medical devices utilizing animal tissues and their derivatives -- Part 3: Validation of the elimination and/ or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents— 30 стр.
