BS EN ISO 11607-2. Packaging for terminally sterilized medical devices. Part 2. Validation requirements for forming, sealing and assembly processes— 29 стр.
Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Part 1: Devices that require cleaning followed by disinfection and/or sterilization— 32 стр.
Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices— 94 стр.
