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消毒和灭菌

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标准编号 标准名称 状态 发布日期
ISO/TS 11137-4:2020 EN Sterilization of health care products -- Radiation-- Part 4:Guidance on process control 现行 2020-06-30
ISO 21881:2019 EN Sterile packaged ready for filling glass cartridges 现行 2019-10-18
ISO 21882:2019 EN Sterile packaged ready for filling glass vials 现行 2019-10-18
ISO 11138-7:2019 EN Sterilization of health care products - Biological indicators- Part 7:Guidance for the selection, use and interpretation of results 现行 2019-03-12
ISO 11607-1:2019 EN Packaging for terminally sterilized medical devices- Part 1:Requirements for materials, sterile barrier systems and packaging systems 现行 2019-01-31
ISO 11607-2:2019 EN Packaging for terminally sterilized medical devices- Part 2:Validation requirements for forming, sealing and assembly processes 现行 2019-01-31
ISO 15883-4:2018 EN Washer-disinfectors- Part 4:Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes 现行 2018-11-12
ISO 11137-1:2006/Amd 2:2018 EN Revision to 4.3.4 and 11.2 现行 2018-11-08
ISO/TS 11135-2:2008 EN Sterilization of health care products — Ethylene oxidePart 2:Guidance on the application of ISO 11135-1 废止 暂无
ISO/TS 17665-2:2009 EN Sterilization of health care products — Moist heatPart 2:Guidance on the application of ISO 17665-1 现行 暂无
ISO/TS 17665-3:2013 EN Sterilization of health care products — Moist heatPart 3:Guidance on the designation of a medical device to a product family and processing category for steam sterilization 现行 暂无
ISO 11137-1:2006/Amd 1:2013 EN Sterilization of health care products — RadiationPart 1:Requirements for development, validation and routine control of a sterilization process for medical devices 现行 暂无
ISO 11140-3:2007/Cor 1:2007 EN ISO 11140-3:2007/Cor 1:2007 EN 现行 暂无
ISO 13408-1:2008/Amd 1:2013 EN Aseptic processing of health care productsPart 1:General requirements 现行 暂无
ISO 13408-6:2005/Amd 1:2013 EN Aseptic processing of health care productsPart 6:Isolator systems 现行 暂无
ISO/TS 11135-2:2008/Cor 1:2009 E ISO/TS 11135-2:2008/Cor 1:2009 E 现行 暂无
ISO 11135:2014 EN Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices 现行 暂无
ISO 14160:2011 EN 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 现行 暂无
ISO 14161:2009 EN Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results 现行 暂无
ISO 14937:2009 EN Sterilization 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 devices 现行 暂无
ISO 15882:2008 EN Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results 现行 暂无
ISO 17664:2004 EN Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices 被代替 暂无
ISO 17664:2017 EN Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices 现行 暂无
ISO 18362:2016 EN Manufacture of cell-based health care products - Control of microbial risks during processing 现行 暂无
ISO 18472:2006 EN Sterilization of health care products — Biological and chemical indicators — Test equipment 被代替 暂无
ISO 18472:2018 EN Sterilization of health care products - Biological and chemical indicators - Test equipment 现行 暂无
ISO 20857:2010 EN Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices 现行 暂无
ISO 25424:2009 EN Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices 现行 暂无
ISO 11135-1:2007 EN Sterilization of health care products — Ethylene oxidePart 1:Requirements for development, validation and routine control of a sterilization process for medical devices 废止 暂无
ISO 11137-1:2006 EN Sterilization of health care products — RadiationPart 1:Requirements for development, validation and routine control of a sterilization process for medical devices 现行 暂无
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