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Showing 1 - 12 from 46 Standards Found 46 Standards
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
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
GSO ISO/TS 22456:2023
ISO/TS 22456:2021 
Gulf Standard
Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
GSO ASTM F3208:2022
ASTM F3208:20 
Gulf Standard
Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
GSO ISO/TS 13004:2021
ISO/TS 13004:2013 
Gulf Standard
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
GSO ISO 11138-2:2021
ISO 11138-2:2017 
Gulf Standard
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
GSO ISO 11137-1:2014/Amd 2:2021
ISO 11137-1:2006/Amd 2:2018 
Amendment to Gulf Standard
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
GSO ASTM F3127:2021
ASTM F3127:16 
Gulf Standard
Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices