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 -- 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 -- Biological indicators -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes— 14 стр.
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices— 20 стр.