Sterility


EN 285

Sterilization - Steam sterilizers - Large sterilizers

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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 1422

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

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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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