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Manufacture of cell-based health care products — Control of microbial risks during processing — Amendment 1
60.60 Standard published
Sterilization of health care products — Biological and chemical indicators — Test equipment
90.93 Standard confirmed
Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
90.93 Standard confirmed
Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
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
90.93 Standard confirmed
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
Packaging for terminally sterilized medical devices — Part 3: Requirements for process development for forming, sealing and assembly
20.00 New project registered in TC/SC work programme
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
20.00 New project registered in TC/SC work programme
Sterilization of health care products — Biological indicators — Part 6: Biological indicators for hydrogen peroxide sterilization processes
30.20 CD study/ballot initiated
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 — Microbiological methods — Part 1: Determination of a population of microorganisms on products
30.20 CD study/ballot initiated
Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for noncritical medical devices and health care equipment
30.60 Close of voting/ comment period
Sterilization of health care products — Application of ISO/TS 22421 to the requirements for sterilizers used for the terminal sterilization of health care products containing aqueous liquid in sealed containers
30.20 CD study/ballot initiated
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
Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment
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