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Test methods for sterile medical device package—Part 5:Detecting gross leaks in medical packaging by internal pressurization(bubble test)
Standard in brief
Scope of Application：
YY/T 0681的本部分覆盖了医用包装中粗大泄漏的检验。方法灵敏度对250 μm以上孔径的检出概率为81%（见附录B）。该试验方法可用于托盘和组合袋包装。
本试验方法只对纺粘聚烯烃或非透气包装评价了灵敏度，对其他带有透气性材料的包装未评价其灵敏度。
本方法是破坏性试验，试验中需要向包装内部注入空气，形成内压。
Basic information
Standard No：YY/T 0681.5-2010
Standard Name：无菌医疗器械包装试验方法 第5部分：内压法检测粗大泄漏(气泡法)
English Name：Test methods for sterile medical device package—Part 5:Detecting gross leaks in medical packaging by internal pressurization(bubble test)
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 2096-2004
Adopted Standard Name：《内压法检测医用包装粗大泄漏试验方法(气泡法)》
Adoption Level：MOD
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：2012-01-01
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：0681.5
Drafter：张丽梅、范春来、陈方
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
