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Chinese Standard: YY/T 0698.10-2009

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Packaging materials for terminally sterilized medical devices—Part 10:Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches,reels and lids—Requirements and test methods


Standard in brief
Scope of Application:  
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,4.2~4.3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。

Basic information
Standard No:YY/T 0698.10-2009
Standard Name: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
English Name:Packaging materials for terminally sterilized medical devices—Part 10:Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches,reels and lids—Requirements and test methods
Standard Status:现行
Release Date:2009-06-16
Effective Date:2010-12-01
Language of Publication:中文简体

Standard Classification
ICS Number:11.080.040
CCS Number:C31

Related Standards
Referenced Standards:GB/T 451.2,GB/T 451.3,GB/T 454,GB/T 455,GB/T 458,GB/T 4744,GB/T 12914,ISO 6588-2:2005,ISO 11607-1,ASTM D 2724

Publication Information
Number of pages:12
Number of words:13 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2009-11-01

Standard Revision Information
Has Amendment:No

Other Information
Application Dept:国家食品药品监督管理局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:0698.10
Drafter:钱军、吴平
Drafting Organization:山东省医疗器械产品质量检验中心、杜邦中国集团有限公司
Management Organization: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
Proposing Department:全国医用输液器具标准化技术委员会

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