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Method for validation and routine control of sterilization by steam.
20.60 Close of comment period
Method for validation and routine control of sterilization by ethylene oxide.
00.60 Close of review
Method for validation and routine control of sterilization by irradiation.
20.60 Close of comment period
Estimation of the population of microorganisms on product - Guidance
20.60 Close of comment period
Method(s) of bioburden determination - Methods for validating bioburden techniques
10.99 New project approved
Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)
60.60 Standard published
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009)
60.60 Standard published
Sterilization of medical devices - Development, validation and routine control of sterilization processes - Low Temperature Steam and Formaldehyde
20.60 Close of comment period
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
90.92 Standard to be revised
Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
60.60 Standard published
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
90.92 Standard to be revised
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
60.60 Standard published
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
60.60 Standard published
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
60.60 Standard published
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
60.60 Standard published
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
60.60 Standard published
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
60.60 Standard published