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如下标准清单是与本司技术服务相关的部分标准清单,当标准化组织发布新标准后,本司将有专人跟进,随之更新。如您有任何需求或建议,请联系我们。标准清单更新时间:2014/3/18

 

标准类别

标准号

标准名称

与其它标准的关系

包装类

EN ISO 11607-1:2009

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

等同采用 ISO 11607-1:2006 

最终灭菌医疗器械的包装 第1部分:原料、无菌屏障系统和包装系统的要求

EN ISO 11607-2:2006

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)

等同采用 ISO 11607-2:2006 

最终灭菌医疗器械的包装 第2部分:成型、密封和组装过程的确认要求

包装类

EN 868.2-2009

 Packaging for terminally sterilized medical devices - Part 2 Sterilization wrap - Requirements and test methods

 

经灭菌医疗设备用包装材料和系统.灭菌包裹物.要求和试验方法

 

EN 868.3-2009

EN 868-3(2009) Packaging for terminally sterilized medical devices - Part 3 Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of

 

灭菌医疗装置用包装材料和系统.生产纸袋用的纸(EN 868-4规定)和生产盒和卷筒用纸(EN 868-5规定).要求和试验方法

 

EN 868.4-2009

EN 868-4(2009) Packaging for terminally sterilized medical devices -  Part 4 Paper bags - Requirements and test methods

 

经灭菌医疗设备用包装材料和系统.纸袋.要求和试验方法

 

包装类

EN 868.5-2009

EN 868-5(2009) Packaging for terminally sterilized medical devices - Part 5 Sealable pouches and reels of porous materials and plastic film construction - Requirements and test

 

[经灭菌医疗设备用包装材料和系统.纸和塑料薄膜结构的热和可自密封袋状及卷绕材料.要求和试验方法]

 

EN 868.6-2009

EN 868-6(2009) Packaging for terminally sterilized medical devices - Part 6 Paper for low temperature sterilization processes - Requirements and test methods

 

灭菌医疗装置用包装材料和系统.生产经氧化乙烯或辐照灭菌的医用纸包所用的纸.要求和试验方法

 

EN 868.7-2009

EN 868-7(2009) Packaging for terminally sterilized medical devices - Part 7 Adhesive coated paper for low temperature sterilization processes - Requirements and tesf methods

 

经灭菌医疗设备用包装材料和系统.经环氧乙烷或辐射灭菌的医用热密封包装的生产用粘性涂覆纸.要求和试验方法

 

包装类

EN 868.8-2009

EN 868-8(2009) Packaging for terminally sterilized medical devices -Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods

 

经灭菌医疗设备用包装材料和系统.符合EN 285的蒸汽灭菌器用可重复使用的灭菌容器.要求和试验方法

 

EN 868.9-2009

EN 868-9(2009) Packaging for terminally sterilized medical devices -Uncoated nonwoven materials of polyolefines. Requirements and test methods

 

灭菌医疗装置和包装材料.用于生产热密封袋,卷轴和盖的聚烯烃非包覆非织物材料.要求和试验方法

 

EN 868.10-2009

EN 868-10(2009) Packaging for terminally sterilized medical devices -Adhesive coated nonwoven materials of polyolefines. Requirements and test methods

 

灭菌医疗装置和包装材料.用于生产热密封袋,卷轴和盖的聚烯烃胶粘包覆非织物材料.要求和试验方法

 

灭菌类

EN ISO 11135-1:2014

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2014)

取代EN550

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

EN 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 (ISO 11137-1:2006)

等同采用ISO 11137-1:2006
取代EN552

医疗保健产品的灭菌.辐照.第1部分:医疗器械灭菌过程的开发、确认和常规控制的要求

EN ISO 11137-2:2012

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)

等同采用ISO 11137-2:2012 

医疗保健产品的灭菌.辐照.第2部分:灭菌剂量的确定

EN ISO 17665-1:2006

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)

等同采用ISO 11137-1:2006
取代EN554

医疗保健产品的灭菌.湿热.第1部分:医疗器件灭菌过程的开发、确认和常规控制的要求

医用器械的灭菌 微生物学方法

EN ISO 11737-1:2006

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)

等同采用ISO11737-1:2006

医疗器械的灭菌.微生物法.第1部分:产品微生物群体数量的测定 

EN ISO 11737-2:2009

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

等同采用ISO11737-2:2009

医疗器械的灭菌.微生物法.第2部分:在定义、确认和维护灭菌过程中的无菌检测