ISO/TC 198
Registration number (WIID) | Project No. | Title | Status |
---|---|---|---|
60165 | ISO 11137-1:2006/Amd 1:2013 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1 | Atcelts |
73159 | ISO 14160:2020 | Sterilization 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 devices | Atcelts |
35047 | ISO 18472:2006 | Sterilization of health care products — Biological and chemical indicators — Test equipment | Atcelts |
43350 | ISO 14161:2009 | Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results | Atcelts |
41076 | ISO 15883-1:2006 | Washer-disinfectors — Part 1: General requirements, terms and definitions and tests | Atcelts |
59476 | ISO 13408-6:2005/Amd 1:2013 | Aseptic processing of health care products — Part 6: Isolator systems — Amendment 1 | Atcelts |
59475 | ISO 13408-1:2008/Amd 1:2013 | Aseptic processing of health care products — Part 1: General requirements — Amendment 1 | Atcelts |
33957 | ISO 11138-2:2006 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes | Atcelts |
36708 | ISO/TS 13409:2002 | Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches | Atcelts |
72106 | ISO 11137-1:2006/Amd 2:2018 | 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 | Atcelts |
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