No. | Standard No. | Ver. | Name |
1 | EN 285 | 2006+A2:2009 | Sterilization - Steam sterilizers - Large sterilizers灭菌-蒸汽灭菌器-大型灭菌器 |
2 | EN 556-1/YY/T0615.1 | 2001/AC:2006 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices医疗设备的灭菌 拟被认定为无菌的医疗设备的要求 第1部分:对最终灭菌设备的要求 |
3 | EN 556-2/ YY/T0615.2 | 2003 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aptically procesd medical devices医疗设备的灭菌 拟被认定为无菌的医疗设备的要求 第1部分:无菌加工医疗器械的要求 |
4 | 外国电影推荐EN ISO 11607-1(ISO 11607-1:2006) | 2009 福建省二级建造师报名 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems最终灭菌医疗器械的包装第1部分:材料、灭菌隔层和包装系统的要求 |
5 | EN ISO 11607-2 (ISO 11607-2:2006) | resistant 2006 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, aling and asmbly process 最终灭菌医疗器械的包装 第2部分 成形、密封和装配过程的确认要求 | university of pittsburgh
6 | exercis怎么读EN ISO 11135-1/ ISO 11135-1:2007/GB18279：2000 | 2007 | Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices 医疗保健产品灭菌.环氧乙烷.第1部分:医疗器械灭菌过程开发、确认和常规控制要求柬埔寨怎么读 |
7 | EN ISO 11137-1/ISO 11137-1 | 2006 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices 医疗保健产品灭菌-辐射-第1部分:医疗器械灭菌过程开发、确认和常规控制要求 |
8 | EN ISO 11137-2garfield/ ISO 11137-2 | 妈妈的英文2012 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization do医疗保健产品灭菌-辐射-第2部分:建立灭菌剂量 |
9 | EN ISO 11138-2(ISO 11138-2:2006)/GB18281.2：2000 | 2009 | Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization process医疗保健产品灭菌-生物指示剂-第2部分：环氧乙烷灭菌用生物指示剂 |
10 | EN ISO 11138-3/(ISO 11138-3:2006)2012成都中考/GB18281.3：2000 | 2009 | Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization process 医疗保健产品灭菌-生物指示剂-第3部分：湿热灭菌用生物指示剂 |
11 | EN ISO 11140-1 (ISO 11140-1:2005)/GB18282.1 | 2009 | Sterilization of health care products - Chemical indicators - Part 1: General requirements 医疗保健产品的灭菌-化学指示剂-第1部分：一般要求 |
12 | EN ISO 11140-3(ISO 11140-3:2007, including Cor 1:2007)/GB18282.3 | 2009 | Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for u in the Bowie and Dick-type steam penetration test医疗保健产品的灭菌-化学指示剂-第3部分：用于BD类蒸汽渗透测试的二类指示物系统 |
13 | EN ISO 11737-1(ISO 11737-1:2006)/GBT19973.1-2005 | 2006 | Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products 医疗器械灭菌-微生物方法-第1部分：产品上微生物群落的测定 |
14 | EN ISO 11737-2(ISO 11737-2:2009)/GBT19973.2-2005 | 2009 | Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process医疗器械灭菌-微生物方法-第2部分：定义、确认和保持灭菌过程的无菌试验 |
15 | EN ISO 13408-1 (ISO 13408-1:2008)/YYT0567.1 | 2011 | Aptic processing of health care products - Part 1: General requirements医疗保健产品的无菌加工-第1部分：通用要求 |
16 | EN ISO 13408-2(ISO 13408-2:2003)/YYT0567.2 | 2011 | Aptic processing of health care products - Part 2: Filtration 医疗保健产品的无菌加工-第2部分：过滤 |
17 | EN ISO 13408-3(ISO 13408-3:2006)/YYT0567.3 | 2011 | Aptic processing of health care products - Part 3: Lyophilization医疗保健产品的无菌加工-第3部分：冻干法 |
18 | EN ISO 13408-4(ISO 13408-4:2005)/YYT0567.4 | 2011 | Aptic processing of health care products - Part 4: Clean-in-place technologies 医疗保健产品的无菌加工-第4部分：在线清洗技术 |
19 | EN ISO 13408-5(ISO 13408-5:2006)/YYT0567.5 | 2011 | Aptic processing of health care products - Part 5: Sterilization in place医疗保健产品的无菌加工 第5部分：现场消毒 |
20 | EN ISO 13408-6(ISO 13408-6:2005)/YYT0567.6 | 2011 | Aptic processing of health care products - Part 6: Isolator systems 医疗保健产品的无菌加工-第6部分：隔离器系统 |
21 | EN ISO 14937 (ISO 14937:2009)/GBT19974 | 2009 | 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医疗保健产品灭菌-灭菌因子的特性及医疗器械灭菌工艺的设定、确认和常规控制的通用要求 |
22 | EN ISO 17664 (ISO 17664:2004)/YYT0802 | 2004 | Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices医疗器械的灭菌 制造商提供的处理可重复灭菌医疗器械的信息 |
23 | EN ISO 17665-1(ISO 17665-1:2006) | 2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices 医疗保健产品灭菌-湿热-第1部分：对医疗器械灭菌过程的开发、确认和常规控制的要求 |
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