C08 标志、包装、运输、贮存 标准查询与下载

DIN EN 868-3:2009 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.英文版本DIN EN 868-3-2009-09

This part of EN 868 provides test methods and values for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) used as 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 this part of EN 868 are intended for single use only. NOTE 3 Applicable sterilization methods are specified by the manufacturer.

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; English version of DI

DIN EN 868-7:2009 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.英文版本DIN EN 868-7-2009-09

This part of EN 868 provides test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. The materials specified in this part are intended to be used for ethylene oxide or irradiation sterilization. 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 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 this part of EN 868 are intended for single use only.

Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; English version of DIN EN 868-7:2009-09

DIN EN 868-6:2009 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.英文版本DIN EN 868-6-2009-09

This part of EN 868 provides test methods and values for paper used in the manufacture of preformed 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. Paper specified in this part of the series EN 868 is intended for use in part or complete manufacture of pouches and form and fill packs and lidding material for packs. NOTE 2 The paper specified in this part of the series EN 868 is suitable for the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce coated paper according to EN 868-7. NOTE 3 Paper according to EN 868-3 can also be used for these sterilization processes. The materials specified in this part of EN 868 are intended for single use only. NOTE 4 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 filters, 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.

Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; English version of DIN EN 868-6:2009-09

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 868-2:2009 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

DIN EN 868-5:2009 最终灭菌医疗器械的包装.第5部分:多孔材料和塑料薄膜结构的可密封袋和卷轴.试验方法和要求.英文版本DIN EN 868-5-2009-09

This part of EN 868 provides test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4 used as 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 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. The materials specified in this part of EN 868 are intended for single use only. NOTE 2 When additional materials are used inside the sterile barder 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.

Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods;English version of DIN EN 868-5:2009-09

DIN EN 868-10:2009 最终灭菌医疗器械的包装.第10部分:聚烯烃胶粘包覆无纺材料.试验方法和要求.英文版本DIN EN 868-10-2009-09

This part of EN 868 provides test methods and values for sealable adhesive coated nonwoven materials of polyolefines, manufactured from nonwovens complying with EN 868-9 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 nor 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 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 this part of EN 868 are intended for single use only.

Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; English version of DIN EN 868-10:2009-09

JIS T 0841-2:2009 定期长效消毒医疗设备的包装.第2部分:组成、密封和装配过程的验证要求

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

JIS T 0841-1:2009 定期长效消毒医疗设备的包装.第1部分:材料、消毒隔障体系和包装体系要求

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

NF S98-052-1:2009 灭菌医疗装置的包装.第1部分:材料,消毒系统和包装系统的要求

Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems.

BS EN ISO 15747:2005 静脉注射用塑料容器(ISO 15747-2003)

This International Standard contains requirements related to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This International Standard is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range from 50 ml to 5 000 ml, such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.

Plastic containers for intravenous injection(ISO 15747:2003)

YY/T 0698.10-2009 最终灭菌医疗器械包装材料 第10部分：可密封组合袋、卷材和盖材生产用涂胶聚烯烃非织造布材料 要求和试验方法

YY/T 0698 的本部分提供了适用于最终灭菌医疗器械包装的涂胶聚烯烃非织造布材料的要求和 试验方法。 本部分未对 ISO 11607-1 的通用要求增加要求。因此，4. 2一4. 3 中的专用要求可用以证实符合 ISO 11607-1 的一项或多项要求 ，但不是其全部要求。 本部分所规定的材料预期部分或全部用于可密封组合袋 .成形-填充-密封(FFS)包装和包装盖材的 生产。

Packaging materials for terminally sterilized medical devices-Part 10: Requirements and test methods for adhesive-coated polyolefin nonwoven materials for the production of sealable combination pouches, rolls and lids

YY/T 0698.8-2009 最终灭菌医疗器械包装材料 第8部分：蒸汽灭菌器用重复性使用灭菌容器 要求和试验方法

Packaging materials for terminally sterilized medical devices—Part 8: Requirements and test methods for reusable sterilization containers for steam sterilizers

YY/T 0698.5-2009 最终灭菌医疗器械包装材料 第5部分：透气材料与塑料膜组成的可密封组合袋和卷材 要求和试验方法

Packaging materials for terminally sterilized medical devices-Part 5: Requirements and test methods for sealable combination bags and rolls composed of breathable materials and plastic films

YY/T 0698.4-2009 最终灭菌医疗器械包装材料 第4部分：纸袋 要求和试验方法

YY/T 0698 的本部分提供了用 YY/T 0698 的第 3 部分规定的紙製造的紙袋的要求和试验方法。 本部分未对 ISO 11607-1 的通用要求增加要求。这样，4. 2一4.6 中的專用要求可用以證實符合 ISO 11607-1 的一项或多项要求，但不是其全部要求。 本部分规定的纸袋适用于最终灭菌的医疗器械的包装 。

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

ANSI/ASTM/ISO 5362:2009 麻醉剂储存袋

Anaesthetic Reservoir Bags

ASTM F1886/F1886M-09 目视检查测定医药包装密封件完整性的标准试验方法

Seal attributes can be linked directly to a number of variables in process parameters, equipment, or material, as well as environmental (room temperature and relative humidity). Visual seal characteristics and defects can provide evidence of package integrity and production sealing problems. Visual seal defects often will be the first indication of heat sealing process variation. They also will indicate a lack of, or potential compromise to, package integrity after physical package performance testing. 1.1 This test method covers the determination of channels in the package seal down to a width of 75 μm [0.003 in.] with a 60–100 % probability (see Section 8). 1.1.1 The ability to visually detect channel defects in package seals is highly dependent on the size of channel, the degree of contrast from sealed and unsealed areas, the amount and type of adhesive between the two package layers, reflecting light angle, types of material used, the use of magnification, and the inspector's level of training and experience. 1.2 This test method is applicable to packages with at least one transparent side so that the seal area may be clearly viewed. 1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection

ANSI/HL7 V3 SPL, R 4-2009 HL7版本3标准:结构产品标记.第4版

This is the fourth release of the Structured Product Labeling standard (SPL R4). SPL release 4 is an extension of the SPL release 3 content to cover medical devices and to enable the use of SPL in biologics and veterinary product labeling. Since the last ballot, the Organization id was constrained to 0 to 1, a change was made to revise this to a 0 to many relationship. This ballot is to reconcile this change.

HL7 Version 3 Standard: Structured Product Labeling, Release 4

AAMI TIR31-2008 过程激发装置/用于保健设备的测试包

This technical information report (TIR) is intended to provide technical information that will assist health care facilities in the selection and use of process challenge devices (PCDs). It is to serve as a resource that health care personnel can use when directing questions to the PCD manufacturer about the suitability, effectiveness, and safety of a specific PCD. Currently, there are no standards that define the performance of these medical devices or provide methods to evaluate them. This TIR describes user-assembled PCDs that originally used biological indicators (BIs) to evaluate the ability of a sterilization process to sterilize a known challenge. It also describes user-assembled PCDs that use chemical indicators (CIs) to conduct the Bowie-Dick test for air removal/steam penetration in dynamic-air-removal steam sterilization processes. Preassembled commercial PCDs for sterilization processes that have been cleared for marketing by the U.S. Food and Drug Administration (FDA) can be used as alternatives to the original user-assembled PCDs. PCDs used in liquid chemical sterilization processes are excluded from the scope of this TIR.

Process challenge devices/test packs for use in health care facilities

AAMI TIR22-2007/A1-2008 AAMI TIR 22-2007《ANSI/AAMI/ISO 1160 "定期消毒医疗器械用包装"指南.第1部分和第2部分-2006》修改件1

Amendment 1 to AAMI TIR 22-2007, Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices - Part 1 and Part 2:2006.

Amendment 1 to AAMI TIR 22-2007, Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices - Part 1 and Part 2:2006