|
可再利用的医疗设备杀菌用密封装置
Containment devices for reusable medical device sterilization
参考页数：
|
|
|
|
|
|
保健品杀菌.选择标有"无菌"产品的灭菌保证水平(SAL)的要求和指导
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled sterile
参考页数：
|
|
|
|
|
|
最后灭菌的医疗器械的包装.第1部分:原材料,消毒阻挡系统和包装的要求
Packaging for teminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging
参考页数：43P.;A4
|
|
|
|
|
|
最后灭菌的医疗器械的包装.第2部分:组成,密封和装配过程的确认和要求
Packaging for terminally sterilized medical devices - Part 2: Validation and requirements for forming, sealing and assembly processes
参考页数：28P.;A4
|
|
|
|
|
|
最终灭菌医疗器械的包装.第2部分:消毒包裹物.试验方法和要求;德文版本EN 868-2-2017
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German version EN 868-2:2017
参考页数：26P.;A4
|
|
|
|
|
|
最终灭菌医疗器械的包装.第4部分:纸袋.试验方法和要求;德文版本EN 868-4-2017
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2017
参考页数：18P.;A4
|
|
|
|
|
|
最终灭菌医疗器械的包装.第3部分:生产纸袋(EN 868-4标准指定)和生产盒和卷筒(EN 868-5标准指定)用纸.试验方法和要求;德文版本EN 868-3-2017
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 pouches and reels (specified in EN 868-5) - Requirements and test methods; German version EN 868-3-2017
参考页数：22P.;A4
|
|
|
|
|
|
最终灭菌医疗器械的包装.第7部分:低温消毒处理的粘合铜版纸.试验方法和要求;德文版本EN 868-7-2017
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-7:2017
参考页数：30P.;A4
|
|
|
|
|
|
最终灭菌医疗器械的包装.第6部分:低温灭菌处理用纸.试验方法和要求;德文版本EN 868-6-2017
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-6:2017
参考页数：23P.;A4
|
|
|
|
|
|
最终灭菌医疗器械包装. 第2部分：成形、密封和装配工艺的验证要求(ISO / DIS 1160 7 - 2:2017)；德文和英文版本prEN ISO 11607-2:2017
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO/DIS 11607-2:2017); German and English version prEN ISO 11607-2:2017
参考页数：61P.;A4
|
|
|
|
|
