11.080.30 消毒封装 标准查询与下载

DS/EN 868-7:2009 最终灭菌医疗器械包装 第7部分：低温灭菌过程用涂胶纸要求和试验方法

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 mod

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

DS/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

This part of EN 868 provides test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. These containers are intended to be used in steam sterilizers conforming to EN 285.NOTE 1 The need for a packaging material inside the container is determined by the manufactures and users.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

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

DS/EN 868-9:2009 最终灭菌医疗器械的包装 第9部分：聚烯烃无涂层非织造材料 要求和试验方法

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

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

DS/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

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.Th

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

DS/EN 868-10:2009 最终灭菌医疗器械的包装 第10部分：涂有粘合剂的聚烯烃非织造材料 要求和试验方法

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 parti

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

DS/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

This part of EN 868 provides test methods and values for materials for sterile barrier systems and/orpackaging 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 requiremen

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

DS/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

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 1160

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

DS/EN 868-4:2009 最终灭菌医疗器械包装 第4部分：纸袋要求和试验方法

Part 3 of EN 868 provides test methods and values for paper bags manufactured from paper, 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 4.6 can be used to demonstrate compliance with one or

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

DS/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 要求和试验方法

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 spec

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

DS/EN 868-6:2009 最终灭菌医疗器械的包装 第6部分：低温灭菌过程用纸 要求和试验方法

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

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

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.

KS P ISO 11607-1:2007 终端无菌医学设备的包装.第1部分:材料、无菌屏障系统、包装系统的要求

이 규격에서는 최종 멸균 처리한 의료용품의 멸균 상태를 사용 시점까지 유지하기 위한 재료,

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

KS P ISO 11607-2:2007 终端无菌医学设备的包装.第2部分:成形、密封和装配过程的确认要求

이 규격에서는 최종 멸균되는 의료용품의 포장 공정의 개발 및 검증에 대한 요구사항을 규정한

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

DIN EN 15424:2007 医疗设备灭菌.低温蒸汽和甲醛.医疗设备灭菌过程的制定、确认和常规控制的要求

1.1 Inclusions 1.1.1 This European Standard specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices. NOTE Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. 1.1.2 This European Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices. (See EN ISO 14937:2000, Table E.1) 1.1.3 This European Standard covers sterilization processes which use a mixture of Iow temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only. 1.2 Exclusions 1.2.1 Sterilization processes validated and controlled in accordance with the requirements of this standard should not be assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. 1.2.2 This standard does not specify requirements for designating a medical device as "STERILE". Such requirements are given in EN 556-1. 1.2.3 This standard does not specify a quality management system for the control of all stages of production of medical devices. NOTE It is not a requirement of this standard to have a complete quality management system during manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appropriate places in the text. Attention is drawn to the standards for quality management systems (see EN ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. Further guidance is given in E.2 of EN ISO 14937:2000. 1.2.4 This standard does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities. NOTE 1 Safety requirements for sterilizers are specified in EN 61010-2-040. NOTE 2 Attention is also drawn to the existence in some countries of regulations stipulating safety requirements. 1.2.5 This European Standard does not cover analytical methods for determining levels or residues of formaldehyde and/or its reaction products. NOTE 1 Attention is drawn to EN 14180. NOTE 2 Attention is drawn to the possible existence in some countries of statutory regulation specifying limits for the level of formaldehyde residues on medical devices and products. 1.2.6 This European Standard does not cover preparatory measures that may be necessary before sterilization such as cleaning, disinfection and packing. NOTE For re-sterilizable medical devices, the manufacturer(s) of these devices should supply information on the preparatory measures (see EN ISO 17664).

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices; English version of DIN EN 15424:2007-08

SANS 11607-2:2007 最终消毒医疗设备的包装.第2部分:成型、密封及装配过程的验证要求

Specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

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

SANS 11607-1:2007 最终消毒医疗设备的包装.第1部分:材料、无菌屏障系统及包装的系统要求

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.

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

DIN EN ISO 11607-1 Berichtigung 1:2007 最终灭菌医学设备的封装.第1部分:原材料、无菌阻隔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 (ISO 11607-1:2006); German version EN ISO 11607-1:2006, Corrigenda to DIN EN ISO 11607-1:2006-07

NF S98-052-2:2006 终端无菌医疗设备包装.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.