C08 标志、包装、运输、贮存 标准查询与下载

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 868-3:2009 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

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 868-5:2009 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 868-8:2009 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 868-4:2009 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

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.

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 S98-051-2:2009 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 S98-051-8:2009 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 S98-051-10:2009 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 S98-051-6:2009 灭菌医疗装置的包装材料.第6部分:低温灭菌处理用纸.要求和测试方法

Packaging materials for terminally sterilized medical devices - Part 6 : paper for low temperature sterilization processes - Requirements and test methods.

NF S98-051-7:2009 灭菌医疗装置的包装.第7部分:低温消毒处理用粘合铜版纸.要求和测试方法

Packaging for terminally sterilized medical devices - Part 7 : adhesive coated paper for low temperature sterilization processes - Requirements and test methods.

NF S98-051-9:2009 灭菌医疗装置的包装材料.第9部分:聚烯烃非包覆非织物材料.要求和测试方法

Packaging materials for terminally sterilized medical devices - Part 9 : uncoated nonwoven materials of polyolefines - Requirements and test methods.

NF S98-051-5:2009 灭菌医疗装置的包装.第5部分:多孔材料和塑料膜结构的可密封袋和卷轴.要求和测试方法

Packaging for terminally sterilized medical devices - Part 5 : sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods.

NF S93-123-3*NF EN ISO 8536-3:2009 医用输液设备.第3部分:输液瓶用铝盖

Infusion equipment for medical use - Part 3 : aluminium caps for infusion bottles.

DIN EN ISO 11607-1:2009 最终无菌医疗器械的包装.第1部分:原材料,无菌阻隔系统和包装系统的要求(ISO 11607-1-2006).英文版本DIN EN ISO 11607-1-2009-09

This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations. This part of ISO 11607 does net describe a quality assurance system for control of all stages of manufacture.

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); English version of DIN EN ISO 11607-1:2009-09

DIN EN 868-9:2009 最终灭菌医疗器械的包装.第9部分:聚烯烃非包覆无纺材料.试验方法和要求.英文版本DIN EN 868-9-2009-09

This part of EN 868 provides test methods and values for uncoated nonwoven materials of polyolefines used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. NOTE 2 When additional materials are used inside the stedle barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply. The materials specified in this part of EN 868 are intended for single use only.

Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods; English version of DIN EN 868-9:2009-09

DIN EN 868-2:2009 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.英文版本DIN EN 868-2-2009-09

This part of EN 868 provides test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply. The materials specified in 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single use, the materials specified in 4.2.2.4 are intended for reuse. NOTE 3 If the intended purpose according to the manufacturer of the material for sterile barrier system specifies the use as sterile field, then the additional requirements of the EN 13795 series apply.

Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; English version of DIN EN 868-2:2009-09