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ISO 13408-2:2018PublishedAseptic processing of health care products — Part 2: Sterilizing filtrationISO 13408-7:2012PublishedAseptic processing of health care products — Part 7: Alternative processes for medical devices and combination productsISO 13408-3:2006PublishedAseptic processing of health care products — Part 3: LyophilizationISO 13408-5:2006PublishedAseptic processing of health care products — Part 5: Sterilization in placeISO 13408-4:2005PublishedAseptic processing of health care products — Part 4: Clean-in-place technologiesISO 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 devicesISO 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 devicesISO 15882:2008PublishedSterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of resultsISO/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 classificationISO 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 devicesISO 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 devicesISO 17665:2024PublishedSterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devicesISO 18362:2016PublishedManufacture of cell-based health care products — Control of microbial risks during processingISO 18472:2018PublishedSterilization of health care products — Biological and chemical indicators — Test equipmentISO/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 10-6ISO/TR 20520:2018PublishedTraditional Chinese medicine — Infection control for acupuncture treatmentISO 20857:2010PublishedSterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devicesISO/TS 21387:2020PublishedSterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric releaseISO/TS 22421:2021PublishedSterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilitiesISO 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 devicesISO/TS 22456:2021PublishedSterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based productsISO 25424:2018PublishedSterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devicesISO/FDIS 11135Under developmentSterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devicesISO/DIS 11137-2Under developmentSterilization of health care products — Radiation — Part 2: Establishing the sterilization doseISO/DIS 11138-6Under developmentSterilization of health care products — Biological indicators — Part 6: Biological indicators for vaporized hydrogen peroxide sterilization processes