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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
60.60 Standard published
Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
30.60 Close of voting/ comment period
Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
30.60 Close of voting/ comment period
Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
30.60 Close of voting/ comment period
Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
40.60 Close of voting
Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
50.00 Final text received or FDIS registered for formal approval
Traditional Chinese medicine — Infection control for acupuncture treatment
60.60 Standard published
Sterilization of health care products — Radiation — Part 4: Guidance on process control
90.93 Standard confirmed
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
90.93 Standard confirmed
Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
90.60 Close of review
Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
90.20 Standard under periodical review
Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
90.20 Standard under periodical review
Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products
60.60 Standard published