ISO/TC 198

Registration number (WIID)Project No.TitleStatus
27035ISO/TS 15843:2000Sterilization of health care products — Radiation sterilization — Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose auditsAtcelts
41175ISO/TS 15883-5:2005Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning efficacyAtcelts
52517ISO/TS 16775:2014Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2Atcelts
76555ISO/TS 16775:2021Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2Standarts spēkā
43188ISO/TS 17665-2:2009Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1Atcelts
54997ISO/TS 17665-3:2013Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilizationAtcelts
66566ISO/TS 19930:2017Guidance 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 10-6Atcelts
70849ISO/TS 21387:2020Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric releaseStandarts spēkā
73158ISO/TS 22421:2021Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilitiesStandarts spēkā
73256ISO/TS 22456:2021Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based productsStandarts spēkā
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