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Sterilization of healthcare products -- Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1