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Chinese Standard: YY/T 0698.3-2009

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Packaging materials for terminal sterilized medical devices—Part 3:Paper for use in the manufacture of paper bags(specified in YY/T 0698.4)and in the manufacture of pouches and reels(specified in YY/T 0698.5)—Requirements and test methods


Standard in brief
Scope of Application:  
YY/T 0698的本部分提供了纸袋(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。
本部分所规定的纸适用于对最终灭菌医医疗器的包装。

Basic information
Standard No:YY/T 0698.3-2009
Standard Name:最终灭菌医疗器械包装材料 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
English Name:Packaging materials for terminal sterilized medical devices—Part 3:Paper for use in the manufacture of paper bags(specified in YY/T 0698.4)and in the manufacture of pouches and reels(specified in YY/T 0698.5)—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 454,GB/T 455,GB/T 458,GB/T 465.1,GB/T 465.2,GB/T 1540,GB/T 1545,GB/T 2678.6,GB/T 7408,GB/T 7974-2002,GB/T 12914,ISO 6588-2:2005,ISO 9197,ISO 11607-1
Adopted Standards:prEN 868-3:2007
Adopted Standard Name:《最终灭菌医疗器械包装材料:第3部分:袋(EN 868-4所规定)和卷材(EN 868-5所规定)生产用纸 通用要求和试验方法》
Adoption Level:IDT

Publication Information
Number of pages:12
Number of words:16 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:0698.3
Drafter:闫宁、宋龙富、张洪辉、吴平
Drafting Organization:山东省医疗器械产品质量检验中心、上海康德莱企业发展集团有限公司
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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