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Test methods for sterile medical device package—Part 13:Slow rate penetration resistance of flexible barrier films and laminates
Standard in brief
Scope of Application：
YY/T 0681的本部分适用于测定软性屏障膜和复合膜抗驱动测头的戳穿性。本试验在室温下以恒定的试验速率对材料施加双轴应力，直到戳穿发生，测定穿孔前的力、能量和伸长。
注： 附录A给出了本部分规定的试验方法的精密度和偏倚。
Basic information
Standard No：YY/T 0681.13-2014
Standard Name：无菌医疗器械包装试验方法 第13部分：软性屏障膜和复合膜抗慢速戳穿性
English Name：Test methods for sterile medical device package—Part 13:Slow rate penetration resistance of flexible barrier films and laminates
Standard Status：现行
Release Date：2014-06-17
Effective Date：2015-07-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.080.040
CCS Number：C31
Related Standards
Referenced Standards：GB/T 2918
Publication Information
Number of pages：12
Number of words：15 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2014-11-01
Standard Revision Information
Has Amendment：No
Other Information
Application Dept：国家食品药品监督管理总局
Standard Type：QT
Standard Attribute：YY
Other Standard Number：0681.13
Drafter：张静、董丹丹、陈方、于晓慧、王洪敏
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(SAC/TC 106)
