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Test methods for sterile medical device package—Part 11:Determining integrity of seals for medical packaging by visual inspection
Standard in brief
Scope of Application：
YY/T 0681的本部分规定的试验方法能够以60%~100%的概率（见附录B)确定75 μm以上宽度的通道。
本试验方法适用于至少一面透明的软材料包装和硬材料包装，这样密封区可以清晰地观察到。
Basic information
Standard No：YY/T 0681.11-2014
Standard Name：无菌医疗器械包装试验方法 第11部分：目力检测医用包装密封完整性
English Name：Test methods for sterile medical device package—Part 11:Determining integrity of seals for medical packaging by visual inspection
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：ASTM F 17
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：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：0681.11
Drafter：董丹丹、张静、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)
