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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 — 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 — 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 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 2: Establishing the sterilization dose — Amendment 1

60.60 Standard published

ISO/TC 198

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

90.92 Standard to be revised

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 — Radiation — Part 4: Guidance on process 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

Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes

90.93 Standard confirmed

ISO/TC 198

Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

90.93 Standard confirmed

ISO/TC 198

Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results

90.93 Standard confirmed

ISO/TC 198

Sterilization of health care products — Biological indicators — Part 8: Method for validation of a reduced incubation time for a biological indicator

60.60 Standard published

ISO/TC 198

Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards — Amendment 1: Amended and additional terms and definitions

60.60 Standard published

ISO/TC 198

Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards

90.93 Standard confirmed

ISO/TC 198