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ISO/TS 5111:2022PublishedGuidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care productsTechnical Specification · Published 19 Dec 2022 · ISO/TC 198ISO 11135:2014PublishedSterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devicesInternational Standard · Published 7 Jul 2014 · ISO/TC 198ISO 11137-1:2025PublishedSterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devicesInternational Standard · Published 2 Apr 2025 · ISO/TC 198ISO/TS 11137-4:2020PublishedSterilization of health care products — Radiation — Part 4: Guidance on process controlTechnical Specification · Published 30 Jun 2020 · ISO/TC 198ISO 11137-3:2017PublishedSterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine controlInternational Standard · Published 26 Jun 2017 · ISO/TC 198ISO 11137-2:2013PublishedSterilization of health care products — Radiation — Part 2: Establishing the sterilization doseInternational Standard · Published 21 May 2013 · ISO/TC 198ISO 11138-8:2021PublishedSterilization of health care products — Biological indicators — Part 8: Method for validation of a reduced incubation time for a biological indicatorInternational Standard · Published 20 Jul 2021 · ISO/TC 198ISO 11138-7:2019PublishedSterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of resultsInternational Standard · Published 12 Mar 2019 · ISO/TC 198ISO 11138-1:2017PublishedSterilization of health care products — Biological indicators — Part 1: General requirementsInternational Standard · Published 3 Mar 2017 · ISO/TC 198ISO 11138-2:2017PublishedSterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processesInternational Standard · Published 3 Mar 2017 · ISO/TC 198ISO 11138-3:2017PublishedSterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processesInternational Standard · Published 3 Mar 2017 · ISO/TC 198ISO 11138-4:2017PublishedSterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processesInternational Standard · Published 3 Mar 2017 · ISO/TC 198ISO 11138-5:2017PublishedSterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processesInternational Standard · Published 3 Mar 2017 · ISO/TC 198ISO 11139:2018PublishedSterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standardsInternational Standard · Published 3 Aug 2018 · ISO/TC 198ISO 11140-6:2022PublishedSterilization of health care products — Chemical indicators — Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizersInternational Standard · Published 22 Nov 2022 · ISO/TC 198ISO 11140-1:2014PublishedSterilization of health care products — Chemical indicators — Part 1: General requirementsInternational Standard · Published 31 Oct 2014 · ISO/TC 198ISO 11140-3:2007PublishedSterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration testInternational Standard · Published 15 Mar 2007 · ISO/TC 198ISO 11140-5:2007PublishedSterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal testsInternational Standard · Published 15 Mar 2007 · ISO/TC 198ISO 11140-4:2007PublishedSterilization 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 penetrationInternational Standard · Published 15 Mar 2007 · ISO/TC 198ISO 11737-3:2023PublishedSterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testingInternational Standard · Published 26 Jun 2023 · ISO/TC 198ISO 11737-2:2019PublishedSterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization processInternational Standard · Published 2 Dec 2019 · ISO/TC 198ISO 11737-1:2018PublishedSterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on productsInternational Standard · Published 12 Jan 2018 · ISO/TC 198ISO 13004:2022PublishedSterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSDInternational Standard · Published 7 Oct 2022 · ISO/TC 198ISO 13408-1:2023PublishedAseptic processing of health care products — Part 1: General requirementsInternational Standard · Published 15 Aug 2023 · ISO/TC 198ISO 13408-6:2021PublishedAseptic processing of health care products — Part 6: Isolator systemsInternational Standard · Published 13 Apr 2021 · ISO/TC 198