11.080.30 消毒封装 标准查询与下载

ISO 11607-2:2019/FDAmd 1 最终灭菌医疗器械包装 第2部分：成型、密封和组装过程的验证要求 修正案 1

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1

ISO 11607-1:2019/FDAmd 1 最终灭菌医疗器械包装 第1部分：材料、无菌屏障系统和包装系统的要求 修正案1

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1

BS EN 868-5:2009 最终灭菌医疗器械的包装.多孔和塑料薄膜结构的密封袋和卷轴.试验方法和要求

Packaging for terminally sterilized medical devices - Sealable pouches and reels of porous and plastic film construction - Requirements and test methods

BS EN 868-4:2009 最终灭菌医疗器械的包装.纸袋.试验方法和要求

Packaging for terminally sterilized medical devices - Paper bags - Requirements and test methods

BS EN 868-8:2009 最终灭菌医疗器械的包装.符合EN 285标准的蒸汽灭菌器的重复使用灭菌容器.试验方法和要求

Packaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285: Requirements and test methods

BS EN 868-2:2009 最终灭菌医疗器械的包装.灭菌套.试验方法和要求

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

BS EN 868-10:2009 最终灭菌医疗器械的包装.聚烯烃粘性涂覆非织物材料.试验方法和要求

Packaging for terminally sterilized medical devices - Adhesive coated nonwoven materials of polyolefines - Requirements and test methods

BS EN 868-9:2009 最终灭菌医疗器械的包装.聚烯烃非包覆非织物材料.试验方法和要求

Packaging for terminally sterilized medical devices - Uncoated nonwoven materials of polyolefines - Requirements and test methods

BS EN 868-7:2009 最终灭菌医疗器械的包装.低温消毒处理用粘合铜版纸.试验方法和要求

Packaging for terminally sterilized medical devices - Adhesive coated paper for low temperature sterilization processes - Requirements and test methods

BS EN 868-6:2009 最终灭菌医疗器械的包装.低温灭菌处理用纸.试验方法和要求

Packaging for terminally sterilized medical devices - Paper for low temperature sterilization processes - Requirements and test methods

BS EN 868-3:2009 最终灭菌医疗器械的包装.生产纸袋(EN 868-4标准规定)和生产盒和卷筒用纸(EN 868-5标准规定)试验方法和要求

Packaging for terminally sterilized medical devices - 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

NF S98-051-2:2009 灭菌医疗装置的包装材料.第2部分:杀菌套要求和测试方法

Packaging materials for terminally sterilized medical devices - Part 2 : sterilization wrap - Requirements and test methods.

NF S98-051-3:2009 灭菌医疗装置的包装.第3部分:生产纸袋(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

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.

NF S98-051-10:2009 灭菌医疗装置的包装.第10部分:聚烯烃粘性涂覆非织物材料的要求和测试方法

Packaging for terminally sterilized medical devices - Part 10 : adhesive coated nonwoven materials of polyolefines - Requirements and test methods.

NF S98-051-8:2009 灭菌医疗装置的包装.第8部分:符合EN 285标准的蒸汽灭菌器用再用灭菌容器的要求和测试方法

Packaging for terminally sterilized medical devices - Part 8 : re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods.

NF S98-051-4:2009 灭菌医疗装置的包装.第4部分:杀菌套要求和测试方法

Packaging for terminally sterilized medical devices - Part 4 : paper bags - Requirements and test methods.

LST EN ISO 11607-1:2009 最终灭菌医疗器械的包装 第1部分：材料、无菌屏障系统和包装系统的要求（ISO 11607-1:2006）

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

LST EN 868-8-2009 最终灭菌医疗器械的包装 第8部分：符合 EN 285 的蒸汽灭菌器的可重复使用的灭菌容器 要求和测试方法

Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods

LST EN 868-2-2009 最终灭菌医疗器械的包装 第2部分：灭菌包裹 要求和试验方法

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

LST EN 868-3-2009 最终灭菌医疗器械的包装 第3部分：用于制造纸袋（在 EN 868-4 中指定）和用于制造袋子和卷轴（在 EN 868-5 中指定）的纸 要求和测试方法

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