AIMDD Sterility
EN 556-1
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556-2
terilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
EN ISO 11135-1
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 11137-1
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 11137-2
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
EN ISO 11138-3
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
EN ISO 11138-2
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
EN ISO 11140-1
Sterilization of health care products - Chemical indicators - Part 1: General requirements
EN ISO 11607-1
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN ISO 11737-1
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products