AIMDD
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
EN ISO 11737-2
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
EN ISO 14937
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
EN ISO 17665-1
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices