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Test methods for sterile medical device package—Part 2:Seal strength of flexible battier materials
Standard in brief
Scope of Application:
YY/T 0681的本部分包括了软性屏障材料密封强度的测量。
本试验可以对软性材料与刚性材料间的密封进行试验。
符合本试验方法的密封样品可来自于任何渠道,可以在实验室形成,也可以来自于商品。
本试验方法可测量密封试样所需的分离力,还能识别试样破坏的类型。
注: 附录C和附录D分别给出了本标准规定的试验方法的精密度和偏倚,及其确定的相关信息。
Basic information
Standard No:YY/T 0681.2-2010
Standard Name:无菌医疗器械包装试验方法 第2部分:软性屏障材料的密封强度
English Name:Test methods for sterile medical device package—Part 2:Seal strength of flexible battier materials
Standard Status:现行
Release Date:2010-12-27
Effective Date:2012-06-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.080.40
CCS Number:C31
Related Standards
Referenced Standards:GB/T 2918
Adopted Standards:ASTM F 88-2006
Adopted Standard Name:《软性屏障材料的密封强度试验方法标准》
Adoption Level:MOD
Publication Information
Number of pages:20
Number of words:31 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2012-02-01
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:0681.2
Drafter:吴平、陈方、董丹丹
Drafting Organization:山东省医疗器械产品质量检验中心
Management Organization:全国医用输液器具标准化技术委员会