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Test methods for sterile medical device package—Part 18:Nondestructive detection of leaks in packages by vacuum decay method
Standard in brief
Scope of Application：
YY/T 0681的本部分规定了用真空衰减法无损检验无菌医疗器械包装系统泄漏的测试方法。
本部分适用于硬质和半硬质无盖托盘、有透气屏障盖材的托盘或托杯、非透气硬包装、非透气软包装。
Basic information
Standard No：YY/T 0681.18-2020
Standard Name：无菌医疗器械包装试验方法 第18部分：用真空衰减法无损检验包装泄漏
English Name：Test methods for sterile medical device package—Part 18:Nondestructive detection of leaks in packages by vacuum decay method
Standard Status：现行
Release Date：2020-03-31
Effective Date：2021-04-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.080.40
CCS Number：C31
Related Standards
Referenced Standards：GB/T 19633.1
Publication Information
Number of pages：24
Number of words：42 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2020-04-01
Standard Revision Information
Has Amendment：No
Other Information
Application Dept：国家药品监督管理局
Standard Type：QT
Standard Attribute：YY
Other Standard Number：0681.18
Drafter：盛洪辉、张鹏、孙海鹏、钱承玉、王冬伟、李然
Drafting Organization：上海众林机电设备有限公司、山东省医疗器械产品质量检验中心、上海微创医疗器械(集团)有限公司
Management Organization：全国医用输液器具标准化技术委员会(SAC/TC 106)
Proposing Department：国家药品监督管理局
