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Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)
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 health care products — Radiation — Part 4: Guidance on process control
60.60 Standard published
Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
60.60 Standard published
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
60.60 Standard published
Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
60.60 Standard published
Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
60.60 Standard published
Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products
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)
40.60 Close of voting
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)
40.60 Close of voting
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 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
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 (ISO 11135:2014)
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/FDIS 25424:2018)
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
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