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Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
60.60 Standard published
Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
60.60 Standard published
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
60.60 Standard published
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
60.60 Standard published
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)
60.60 Standard published
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 (ISO 14937:2009)
60.60 Standard published
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
60.60 Standard published
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
60.60 Standard published
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
60.60 Standard published
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
60.60 Standard published
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
60.60 Standard published
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 (ISO 25424:2018/Amd 1:2022)
60.60 Standard published
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
50.60 Close of voting. Proof returned by secretariat
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: requirements for aseptically processed medical devices
45.99 Dispatch of FV draft to CCMC
Sterilization of medical devices - Validation and routine control of sterilization by irradiation
10.99 New project approved
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 3: Guidance on the designation of a reusable medical device to a quantitative cleaning classification
10.99 New project approved
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 4: Guidance on the evaluation and interpretation of bioburden data
10.99 New project approved
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2024)
40.60 Close of voting