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ISO 11137-1:2025
International Standard
Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
GSO ISO 17664-1:2024
ISO 17664-1:2021
Gulf Standard
Processing of health care products
— Information to be provided by the medical device manufacturer for the processing of medical devices
— Part 1: Critical and semi-critical medical devices
ISO 17665:2024
International Standard
Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
GSO ISO 11737-3:2024
ISO 11737-3:2023
Gulf Standard
Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
GSO ISO 22441:2024
ISO 22441:2022
Gulf Standard
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
ISO 11139:2018/Amd 1:2024
Amendment to International Standard
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
GSO ISO/TS 21387:2023
ISO/TS 21387:2020
Gulf Standard
Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
GSO ISO/TS 22421:2023
ISO/TS 22421:2021
Gulf Standard
Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
GSO ISO 13408-6:2023
ISO 13408-6:2021
Gulf Standard
Aseptic Processing of Health Care Products — Part 6: Isolator Systems
GSO ISO 17664-2:2023
ISO 17664-2:2021
Gulf Standard
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
GSO ISO 11737-1:2020/Amd 1:2023
ISO 11737-1:2018/Amd 1:2021
Amendment to Gulf Standard
Sterilization of Health Care Products — Microbiological Methods — Part 1: Determination of a Population of Microorganisms on Products — Amendment 1
ISO 11737-3:2023
International Standard
Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing