消毒和灭菌综合 -环标网

已选条件： 消毒和灭菌综合

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标准编号	标准名称	发布部门	发布日期	状态
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	现行
ISO/TR 20520:2018	Traditional Chinese medicine - Infection control for acupuncture treatment	Internatio..	2018-04-12	现行
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	现行
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	现行
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	现行
ISO 13408-2:2018	Aseptic processing of health care products Part 2: Sterilizing filtration	Internatio..	2018-01-09	现行
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	现行
ISO/FDIS 18472	Sterilization of health care products - Biological and chemical indicators - Test equipment	Internatio..	2017-11-29	现行
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	现行
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	现行
KS P ISO 13408-1:2017	Aseptic processing of health care products - Part 1:General requirements	Korean Sta..	2017-09-29	废止
KS P ISO 13408-6:2017	Aseptic processing of health care products - Part 6:Isolator systems	Korean Sta..	2017-09-29	废止
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	现行
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	现行
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	现行
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	现行
ISO 11138-2:2017	Sterilization of health care products - Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes	Internatio..	2017-03-03	现行
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	现行
ISO 11138-4:2017	Sterilization of health care products - Biological indicators Part 4: Biological indicators for dry heat sterilization processes	Internatio..	2017-03-03	现行
ISO 11138-1:2017	Sterilization of health care products - Biological indicators Part 1: General requirements	Internatio..	2017-03-03	现行

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