这套38份文件已经更新，包括9项新的/修订的标准。它的特点是新的一次性医疗器械灭菌指南，包括动物源性材料（14160）、标有“无菌”标签的产品要求（ST67）、医疗保健产品干热灭菌（20857）、辐射灭菌（11137-2）等。无论是使用内部设施还是合同设施，运送无菌产品的制造商都不应该没有这本书。内容:14937保健品的灭菌-杀菌剂特性和开发的一般要求，医疗器械灭菌过程的验证和常规控制14160含有动物源性材料的一次性医疗器械的灭菌-液体化学灭菌剂灭菌的验证和常规控制14161医疗保健产品的灭菌- 生物指示剂.结果的选择、使用和解释指南15882卫生保健产品的灭菌.化学指示剂.选择指南，结果的使用和解释11737-1医疗器械灭菌-微生物学方法-第1部分:产品上微生物数量的测定11737-2医疗器械灭菌-微生物学方法-第2部分:在灭菌过程的定义、验证和维护中进行的无菌试验72细菌内毒素试验方法，批量试验的常规监测和替代方法17665-1医疗保健产品的灭菌-湿热-第1部分医疗器械灭菌过程的开发、验证和常规控制要求17665- 2医疗产品灭菌-湿热-第2部分:ANSI/AAMI/ISO 17665-120857医疗产品灭菌指南干热:医疗设备灭菌过程的开发、验证和常规控制要求11135-1医疗产品灭菌-环氧乙烷-第1部分:开发要求，医疗器械灭菌过程的验证和常规控制TIR1135-2医疗保健产品的灭菌-环氧乙烷-第2部分:ANSI/AAMI/ISO 11135-1使用环氧乙烷的合同灭菌的应用指南15环氧乙烷灭菌的物理方面TIR16环氧乙烷灭菌的微生物方面TIR28产品的采用和环氧乙烷灭菌的工艺等效性10993- 7医疗器械的生物评价第7部分:环氧乙烷灭菌残留物11137-1医疗保健产品的灭菌辐射第1部分:开发要求，医疗器械灭菌过程的验证和常规控制11137-2医疗保健产品的灭菌-辐射-第2部分:确定灭菌剂量11137-3医疗保健产品的灭菌-辐射-第3部分:剂量学方面的指南33医疗保健产品的灭菌-辐射灭菌-选定灭菌剂量的证实-方法VDmaxTIR35保健品灭菌-辐射灭菌-验证剂量实验和灭菌剂量审核的替代取样计划Stir37保健品灭菌- -辐射——人体组织产品灭菌指南StIR40医疗保健产品灭菌——辐射——使用改进方法的剂量设置指南2TIR29辐射灭菌过程控制指南TIR17灭菌材料的兼容性TIR11139医疗保健产品灭菌——术语ST67医疗保健产品灭菌标有“无菌”标签的产品的设备要求11607-1最终灭菌医疗设备的包装-第1部分:材料、无菌屏障系统和包装要求11607-2最终灭菌医疗设备的包装-第2部分:成型、密封和组装工艺的验证要求ANSI/AAMI/ISO 11607的22指南，最终灭菌医疗器械的包装- 第1部分和第2部分:200613408-1保健品的无菌处理-第1部分:一般要求13408-2保健品的无菌处理-第2部分:过滤13408-3保健品的无菌处理-第3部分:冷冻干燥13408-4保健品的无菌处理-第4部分:清洁就地技术13408-5保健品的无菌处理-第5部分:就地灭菌13408-6保健品的无菌处理第6部分:隔离系统13408-7保健品的无菌处理第7部分:医疗器械和组合产品的替代工艺

This collection of 38 documents has been updated to include nine new/ revised standards. It features new guidance for sterilization of single-use medical devices incorporating materials of animal origins (14160), requirements for products labeled "sterile" (ST67), dry heat sterilization of health care products (20857), radiation (11137-2), and more.Whether using in-house or contract facilities, manufacturers that ship their products sterile should not be without this book.Contents:14937 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 devices14160 Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants14161 Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results15882 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results11737-1 Sterilization of medical devices - Microbiological methods - Part 1: Determination of the population of microorganisms on products11737-2 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization processST72 Bacterial endotoxin-Test methodologies, routine monitoring and alternatives to batch testing17665-1 Sterilization of health care products - Moist heat - Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-120857 Sterilization of health care products-Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devicesTIR11135-2 Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1TIR14 Contract sterilization using ethylene oxideTIR15 Physical aspects of ethylene oxide sterilizationTIR16 Microbiological aspects of ethylene oxide sterilizationTIR28 Product adoption and process equivalence for ethylene oxide sterilization10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals11137-1 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices11137-2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspectsTIR33 Sterilization of health care products - Radiation sterilization - Substantiation of a selected sterilization dose - Method VDmaxTIR35 Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose auditsTIR37 Sterilization of health care products -- Radiation -- Guidance on sterilization of human tissue-based productsTIR40 Sterilization of health care products -- Radiation -- Guidance on dose setting utilizing a Modified Method 2TIR29 Guide for process control in radiation sterilizationTIR17 Compatibility of materials subject to sterilizationTIR11139 Sterilization of health care products - VocabularyST67 Sterilization of medical devices-Requirements for products labeled "STERILE"11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processesTIR22 Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices - Part 1 and Part 2:200613408-1 Aseptic processing of health care products - Part 1: General requirements13408-2 Aseptic processing of health care products - Part 2: Filtration13408-3 Aseptic processing of health care products - Part 3: Lyophilization13408-4 Aseptic processing of health care products - Part 4: Clean-in-place technologies13408-5 Aseptic processing of health care products - Part 5: Sterilization in place13408-6 Aseptic processing of health care products - Part 6: Isolator systems13408-7 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products