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ISO 13408-2:2018PublishedAseptic processing of health care products — Part 2: Sterilizing filtrationInternational Standard · Published 9 Jan 2018 · ISO/TC 198ISO 13408-7:2012PublishedAseptic processing of health care products — Part 7: Alternative processes for medical devices and combination productsInternational Standard · Published 31 Jul 2012 · ISO/TC 198ISO 13408-3:2006PublishedAseptic processing of health care products — Part 3: LyophilizationInternational Standard · Published 1 Sep 2006 · ISO/TC 198ISO 13408-5:2006PublishedAseptic processing of health care products — Part 5: Sterilization in placeInternational Standard · Published 15 Nov 2006 · ISO/TC 198ISO 13408-4:2005PublishedAseptic processing of health care products — Part 4: Clean-in-place technologiesInternational Standard · Published 28 Oct 2005 · ISO/TC 198ISO 14160:2020PublishedSterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devicesInternational Standard · Published 21 Sep 2020 · ISO/TC 198ISO 14937:2009PublishedSterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devicesInternational Standard · Published 14 Oct 2009 · ISO/TC 198ISO 15882:2008PublishedSterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of resultsInternational Standard · Published 21 Aug 2008 · ISO/TC 198ISO/TS 17664-3:2026PublishedProcessing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 3: Guidance on the designation of a reusable medical device to a cleaning classificationTechnical Specification · Published 30 Jun 2026 · ISO/TC 198ISO 17664-2:2021PublishedProcessing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devicesInternational Standard · Published 25 Feb 2021 · ISO/TC 198ISO 17664-1:2021PublishedProcessing 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 devicesInternational Standard · Published 6 Jul 2021 · ISO/TC 198ISO 17665:2024PublishedSterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devicesInternational Standard · Published 1 Mar 2024 · ISO/TC 198ISO 18362:2016PublishedManufacture of cell-based health care products — Control of microbial risks during processingInternational Standard · Published 15 Jan 2016 · ISO/TC 198ISO 18472:2018PublishedSterilization of health care products — Biological and chemical indicators — Test equipmentInternational Standard · Published 16 Aug 2018 · ISO/TC 198ISO/TS 19930:2017PublishedGuidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6Technical Specification · Published 23 Nov 2017 · ISO/TC 198ISO/TR 20520:2018PublishedTraditional Chinese medicine — Infection control for acupuncture treatmentTechnical Report · Published 12 Apr 2018 · ISO/TC 249/SC 1ISO 20857:2010PublishedSterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devicesInternational Standard · Published 17 Aug 2010 · ISO/TC 198ISO/TS 21387:2020PublishedSterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric releaseTechnical Specification · Published 15 Sep 2020 · ISO/TC 198ISO/TS 22421:2021PublishedSterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilitiesTechnical Specification · Published 25 Jan 2021 · ISO/TC 198ISO 22441:2022PublishedSterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devicesInternational Standard · Published 26 Aug 2022 · ISO/TC 198ISO/TS 22456:2021PublishedSterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based productsTechnical Specification · Published 19 Mar 2021 · ISO/TC 198ISO 25424:2018PublishedSterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devicesInternational Standard · Published 19 Oct 2018 · ISO/TC 198ISO/FDIS 11135Under developmentSterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devicesInternational Standard · ISO/TC 198ISO/DIS 11137-2Under developmentSterilization of health care products — Radiation — Part 2: Establishing the sterilization doseInternational Standard · ISO/TC 198ISO/DIS 11138-6Under developmentSterilization of health care products — Biological indicators — Part 6: Biological indicators for vaporized hydrogen peroxide sterilization processesInternational Standard · ISO/TC 198