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

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EN 556-2

terilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

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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

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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

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EN ISO 11137-2

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

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EN ISO 11138-3

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes

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EN ISO 11138-2

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

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EN ISO 11140-1

Sterilization of health care products - Chemical indicators - Part 1: General requirements

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EN ISO 11607-1

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

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EN ISO 11737-1

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products

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