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標準編號 標準名稱 發布部門 發布日期 狀態
ISO 11135:2014/FDAmd 1 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release Internatio.. 2018-05-24 現行
ISO/TR 20520:2018 Traditional Chinese medicine - Infection control for acupuncture treatment Internatio.. 2018-04-12 現行
I.S. EN ISO 13408-2:2018 Aseptic Processing of Health Care Products Part 2: Sterilizing Filtration (iso 13408-2:2018) National S.. 2018-04-10 現行
I.S. EN ISO 11737-1:2018 Sterilization of Health Care Products - Microbiological Methods Part 1: Determination of a Population of Microorganisms on Products (iso 11737-1:2018) National S.. 2018-02-18 現行
ISO 11737-1:2018 Sterilization of health care products - Microbiological methods Part 1: Determination of a population of microorganisms on products Internatio.. 2018-01-12 現行
ISO 13408-2:2018 Aseptic processing of health care products Part 2: Sterilizing filtration Internatio.. 2018-01-09 現行
I.S. EN ISO 17664:2017 Processing of Health Care Products - Information to be Provided by the Medical Device Manufacturer for the Processing of Medical Devices (iso 17664:2017) National S.. 2017-12-24 現行
ISO/FDIS 18472 Sterilization of health care products - Biological and chemical indicators - Test equipment Internatio.. 2017-11-29 現行
ISO/TS 19930:2017 Guidance 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 10-6 Internatio.. 2017-11-23 現行
ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices Internatio.. 2017-10-25 現行
KS P ISO 13408-1:2017 Aseptic processing of health care products - Part 1:General requirements Korean Sta.. 2017-09-29 廢止
KS P ISO 13408-6:2017 Aseptic processing of health care products - Part 6:Isolator systems Korean Sta.. 2017-09-29 廢止
ISO 11137-1:2006/DAmd 2 Sterilization of health care products - Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2 Internatio.. 2017-08-31 現行
ISO/DIS 11138-7 Sterilization of health care products - Biological indicators Part 7: Guidance for the selection, use and interpretation of results Internatio.. 2017-08-31 現行
I.S. EN ISO 11137-3:2017 Sterilization of Health Care Products - Radiation Part 3: Guidance on Dosimetric Aspects of Development, Validation and Routine Control (iso 11137-3:2017) National S.. 2017-08-13 現行
ISO 11137-3:2017 Sterilization of health care products - Radiation Part 3: Guidance on dosimetric aspects of development, validation and routine control Internatio.. 2017-06-26 現行
ISO 11138-2:2017 Sterilization of health care products - Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes Internatio.. 2017-03-03 現行
ISO 11138-5:2017 Sterilization of health care products - Biological indicators Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes Internatio.. 2017-03-03 現行
ISO 11138-4:2017 Sterilization of health care products - Biological indicators Part 4: Biological indicators for dry heat sterilization processes Internatio.. 2017-03-03 現行
ISO 11138-1:2017 Sterilization of health care products - Biological indicators Part 1: General requirements Internatio.. 2017-03-03 現行
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