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Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2018)

60.60 Standard published

CEN/TC 102

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

CEN/TC 204

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

CEN/TC 204

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

CEN/TC 204

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

CEN/TC 204

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

CEN/TC 204

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

CEN/TC 204

Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

90.92 Standard to be revised

ISO/TC 198

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

60.60 Standard published

ISO/TC 198

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

90.92 Standard to be revised

ISO/TC 198

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1

60.60 Standard published

ISO/TC 198

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

60.60 Standard published

ISO/TC 198

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

90.60 Close of review

ISO/TC 198

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1

60.60 Standard published

ISO/TC 198

Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control

90.93 Standard confirmed

ISO/TC 198

Sterilization of health care products — Biological indicators — Part 1: General requirements

90.93 Standard confirmed

ISO/TC 198

Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes

90.93 Standard confirmed

ISO/TC 198

Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes

90.93 Standard confirmed

ISO/TC 198