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YY/T 0698.6-2009

标准搜索结果: 'YY/T 0698.6-2009'
标准号码内文价格(元)第2步交付天数标准名称状态
YY/T 0698.6-2009 英文版 1469 购买 有增值税发票,[PDF]天数 <=3 最终灭菌医疗器械包装材料 第6部分:用于低温灭菌过程或辐射灭菌的无菌屏障系统生产用纸要求和试验方法 有效

   
标准详细信息 YY/T 0698.6-2009; YY/T0698.6-2009; YYT 0698.6-2009; YYT0698.6-2009
中文名称: 最终灭菌医疗器械包装材料 第6部分:用于低温灭菌过程或辐射灭菌的无菌屏障系统生产用纸要求和试验方法
英文名称: Packaging materials for terminal sterilized medical devices. Part 6: Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation. Requirements and test methods
行业: 医药行业标准 (推荐)
中标分类: C31
国际标准分类: 11.080.040
字数估计: 13,000
发布日期: 2009-06-16
实施日期: 2010-12-01
引用标准: GB/T 451.2; GB/T 454; GB/T 455; GB/T 465.1; GB/T 465.2; GB/T 1540; GB/T 1545; GB/T 2678.6; GB/T 458; GB/T 7408; GB/T 7974-2002; GB/T 12914; ISO 6588-2-2005; ISO 9197; ISO 11607-1
采用标准: prEN 868-6-2007, IDT
起草单位: 山东省医疗器械产品质量检验中心、上海建中医疗器械包装有限公司
归口单位: 国家食品药品监督管理局济南医疗器械质量监督检验中心
标准依据: 行业标准备案公告2009年第9号
提出机构: 全国医用输液器具标准化技术委员会
发布机构: 国家食品药品监督管理局
范围: YY/T 0698的本部分提供了使最终灭菌医疗器械在使用前保持无菌的预成形无菌屏障系统和包装系统生产用纸的要求和试验方法。本部分未对ISO 11607-1的通用要求增加要求, 只是在ISO 11607-1、相关国家标准的基础上对各要素提供指南。因此, 4.2~4.3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。

YY/T 0698.6-2009
Packaging materials for terminal sterilized medical devices.Part 6: Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation.Requirements and test methods
ICS 11.080.040
C31
中华人民共和国医药行业标准
YY/T0698.6-2009
最终灭菌医疗器械包装材料
第6部分:用于低温灭菌过程或辐射灭菌
的无菌屏障系统生产用纸
要求和试验方法
2009-06-16发布
2010-12-01实施
国家食品药品监督管理局 发 布
前言
YY/T 0698《最终灭菌医疗器械包装材料》,由以下几部分组成:
---第2部分:灭菌包裹材料 要求和试验方法;
---第3部分:纸袋(YY/T 0698.4所规定)、组合袋和卷材(YY/T 0698.5所规定)生产用纸 要
求和试验方法;
---第4部分:纸袋 要求和试验方法;
---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;
---第6部分:用于低温灭菌过程或辐射灭菌的无菌屏障系统生产用纸 要求和试验方法;
---第7部分:环氧乙烷或辐射灭菌无菌屏障系统生产用可密封涂胶纸 要求和试验方法;
---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;
---第9部分:可密封组合袋、卷材和盖材生产用无涂胶聚烯烃非织造布材料 要求和试验方法;
---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。
本部分为YY/T 0698的第6部分。
其他最终灭菌医疗器械包装材料的要求和试验方法将在其他部分中规定。
YY/T 0698的本部分等同采用prEN868-6:2007《最终灭菌医疗器械包装材料 第6部分:用于环
氧乙烷灭菌或辐射灭菌的无菌屏障系统生产用纸 要求和试验方法》。
本部分的附录A和附录B是规范性附录。
本部分由全国医用输液器具标准化技术委员会提出。
本部分由国家食品药品监督管理局济南医疗器械质量监督检验中心归口。
本部分主要起草单位:山东省医疗器械产品质量检验中心、上海建中医疗器械包装有限公司。
本部分参加起草单位:上海康德莱企业发展集团有限公司。
本部分主要起草人:宋龙富、闫宁、张洪辉、吴平。
YY/T0698.6-2009
引 言
ISO 116071)标准总标题为“最终灭菌医疗器械的包装”,包括两个部分。该标准的第1部分规定了
预期在使用前保持最终灭菌医疗器械无菌的预成形无菌屏障系统、无菌屏障系统和包装系统的通用要
求和试验方法。该标准的第2部分规定了成形、密封和装配过程的确认要求。
每个无菌屏障系统必须满足ISO 11607-1的要求。
YY/T 0698标准可用于证实符合ISO 11607-1规定的一项或多项要求。
1)EN868-1:1997已被ISO 11607-1:2006所代替。我国与ISO 11607对应的标准是 GB/T 19633-2005(ISO
11607:2003,IDT)。请注意GB/T 19633的修订情况。
YY/T0698.6-2009
最终灭菌医疗器械包装材料
第6部分:用于低温灭菌过程或辐射灭菌
的无菌屏障系统生产用纸
要求和试验方法
1 范围
YY/T 0698的本部分提供了使最终灭菌医疗器械在使用前保持无菌的预成形无菌屏障系统和包
装系统生产用纸的要求和试验方法。
本部分未对ISO 11607-1的通用要求增加要求,只是在ISO 11607-1、相关国家标准的基础上对各
要素提供指南。因此,4.2~4.3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。
注1:YY/T 0698本部分规定的纸适用于环氧乙烷、辐射或低温蒸汽甲醛灭菌过程的无菌屏障系统的生产。
注2:YY/T 0698.3规定的纸也可用于这些灭菌过程。
本部分所规定的纸预期部分或全部用于组合袋、成形-填装-密封(FFS)包装和包装的盖材。
2 规范性引用文件
下列文件中的条款通过YY/T 0698本部分的引用而成为本部分的条款。凡是注日期的引用文
件,其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本部分,然而,鼓励根据本部分达
成协议的各方研究是否可使用这些文件的最新版本。凡是不注日期的引用文件,其最新版本适用于
本部分。
GB/T 451.2 纸和纸板定量的测定(GB/T 451.2-2002,eqv ISO 536:1995)
GB/T 454 纸耐破度的测定(GB/T 454-2002,idt ISO 2758:2001)
GB/T 455 纸和纸板撕裂度的测定(GB/T 455-2002,eqv ISO 1974:1990)
GB/T 465.1 纸和纸板 浸水后耐破度的测定法(GB/T 465.1-2008,ISO 3689:1983,IDT)
GB/T 465.2 纸和纸板 浸水后抗张强度的测定法(GB/T 465.2-2008,ISO 3781:1983,IDT)
GB/T 1540 纸和纸板吸水性的测定 可勃法(GB/T 1540-2002,neq ISO 535:1991)
GB/T 1545 纸、纸板和纸浆水抽提液pH的测定(GB/T 1545-2008,ISO 6588:1981,MOD)
GB/T 2678.6 纸、纸板和纸浆水溶性硫酸盐的测定(电导滴定法)(GB/T 2678.6-1996,
eqv ISO 9198:1989)
GB/T 458 纸和纸板 透气度的测定(GB/T 458-2008,ISO 5636-2:1984,ISO 5636-3:1992,
ISO 5636-5:2003,MOD)
GB/T 7408 数据元和交换格式 信息交换 日期和时间表示法(GB/T 7408-2005,ISO 8601:
2000,IDT)
GB/T 7974-2002 纸、纸板和纸浆亮度的测定 漫射/垂直法(neq ISO 2470:1999)
GB/T 12914 纸和纸板抗张强度的测定法(恒速拉伸法)(GB/T 12914-1991,eqv ISO 1924-2:
1985)
ISO 6588-2:2005 纸、纸板和纸浆 水抽提液pH的测定 第2部分:热抽提
ISO 11607-1 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
YY/T0698.6-2009

YY/T 0698.6-2009
Packaging materials for terminal sterilized medical devices.Part 6. Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation.Requirements and test methods
ICS 11.080.040
C31
People's Republic of China pharmaceutical industry standards
Terminally sterilized medical devices packaging materials
Part 6. for low temperature sterilization or radiation sterilization
Sterile barrier system of paper production
Requirements and test methods
Posted 2009-06-16
2010-12-01 implementation
State Food and Drug Administration issued
Foreword
YY/T 0698 "terminally sterilized medical device packaging materials," consists of the following components.
--- Part 2. Sterilization wrap material requirements and test methods;
--- Part 3. paper (YY/T 0698.4 forth), a combination of bags and coils (YY/T 0698.5 forth) to produce paper
Sum Test methods;
--- Part 4. Paper bags - Requirements and test methods;
--- Part 5. sealable bags and coil combination requirements and test methods breathable material and plastic film composition;
--- Part 6. Requirements and test methods for the production of paper sterile barrier system or low temperature sterilization processes for radiation sterilization;
--- Part 7. ethylene oxide or radiation sterilization production sealable adhesive paper requirements and test methods for sterile barrier system;
--- Part 8. steam sterilizers repeatability requirements and test methods for sterilizing containers;
--- Part 9. combination sealable bags, and the cover sheet material production without nonwovens requirements and test methods for coating polyolefin;
--- Part 10. combination sealable bags, and the cover sheet material production nonwovens requirements and test methods for coating polyolefin.
This section YY/T Section 60698 of.
Requirements and test methods other terminally sterilized medical devices packaging material will be covered in other sections.
YY/T 0698 is identical with this part prEN868-6.2007 "terminally sterilized medical device packaging materials - Part 6. a ring
Ethylene oxide sterilization or radiation sterilization of the sterile barrier system of paper production requirements and test methods. "
This section of the Appendices A and B are normative appendix.
This part of the National Standardization Technical Committee appliances medical infusion made.
This part of the jurisdiction of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
This part mainly drafted by. Shandong Province Medical Devices Product Quality Inspection Center, Shanghai Jianzhong medical equipment Packing Co., Ltd.
Participated in the drafting of this section. Shanghai Kindly Enterprise Development Group Company Limited.
The main drafters of this section. Songlong Fu Yan Ning, Zhang Honghui, Wu Ping.
introduction
ISO 116071) standard the general title "Packaging for terminally sterilized medical devices", consists of two parts. Part 1 of this standard specifies
Expected before use to keep terminally sterilized medical devices to common sterile preformed sterile barrier systems, sterile barrier systems and packaging systems
Sum test methods. Part 2 of this standard specifies validation requirements forming, sealing and assembly processes.
Each sterile barrier system must meet the requirements of ISO 11607-1.
YY/T 0698 standard can be used to demonstrate compliance with one or more of the requirements specified in ISO 11607-1.
1) EN868-1.1997 has been ISO 11607-1.2006 is replaced. Our correspondence with the ISO 11607 standard is GB/T 19633-2005 (ISO
11607.2003, IDT). Please note that the revision of GB/T 19633 of.
Terminally sterilized medical devices packaging materials
Part 6. for low temperature sterilization or radiation sterilization
Sterile barrier system of paper production
Requirements and test methods
1 Scope
YY/T 0698 This section provides so terminally sterilized medical devices prior to use to maintain a sterile barrier systems and preformed sterile package
Requirements and test methods for the production of paper loading system.
This part is not general requirements for ISO 11607-1 requirements increase, but in ISO 11607-1, the relevant national standards on the basis of each
Elements provide guidance. Thus, in the 4.2 to 4.3-specific requirements can be used to demonstrate compliance with one or more of the requirements of ISO 11607-1, but not
All of its requirements.
Note 1. YY/T 0698 provisions of this Part apply to paper, ethylene oxide, radiation to produce a sterile barrier system or low temperature steam formaldehyde sterilization process.
Note 2. Paper YY/T 0698.3 article may also be used for the sterilization process.
Paper expected part of this Part or all of the bags used in combination, forming - lidding seal (FFS) packaging and packaging - filled.
2 Normative references
The following documents contain provisions which, through reference YY/T 0698 and become part of the provisions of this section. For dated reference documents
Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section
Research into whether the parties to the agreement to use the latest versions of these documents. For undated references, the latest version applies to
This section.
GB/T 451.2 Paper and paperboard quantitative determination (GB/T 451.2-2002, eqv ISO 536.1995)
GB/T 454 Determination of bursting strength of paper (GB/T 454-2002, idt ISO 2758.2001)
GB/T 455 Paper and board - Determination of tearing resistance (GB/T 455-2002, eqv ISO 1974.1990)
GB/T 465.1 Paper and paperboard bursting strength after immersion in water assay (GB/T 465.1-2008, ISO 3689. 1983, IDT)
GB/T 465.2 after soaking paper and board Determination of tensile strength (GB/T 465.2-2008, ISO 3781. 1983, IDT)
GB/T 1540 Determination of absorbent paper and cardboard Cobb method (GB/T 1540-2002, neq ISO 535.1991)
GB/T 1545 paper, board and pulp - Determination of pH of aqueous extracts (GB/T 1545-2008, ISO 6588. 1981, MOD)
GB/T 2678.6 paper, board and pulp - Determination of water soluble sulphates (conductometric titration) (GB/T 2678.6-1996,
eqv ISO 9198. 1989)
GB/T 458 Paper and board - Determination of air permeability (GB/T 458-2008, ISO 5636-2. 1984, ISO 5636-3.1992,
GB/T 7408 Data elements and interchange formats - Information interchange the date and time notation (GB/T 7408-2005, ISO 8601.
2000, IDT)
GB/T 7974-2002 paper, paperboard and pulp brightness measured diffusion/vertical method (neq ISO 2470.1999)
GB/T 12914 Paper and board - Determination of tensile strength (constant speed stretching method) (GB/T 12914-1991, eqv ISO 1924-2.
1985)
ISO 6588-2.2005 Paper, board and pulp - Determination of pH of aqueous extracts - Part 2. Hot Extraction
ISO 9197 Determination of paper, paperboard and pulp water-soluble chlorides
Requested materials, sterile barrier systems and packaging systems. ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1
   
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