This standard is the Chinese version electronic standard. After you successfully purchase, we will send the electronic version of this standard to your email address. If you have any question, please contact email: ChineseStandardsLibraryS001@gmail.com.
Test methods for sterile medical device package—Part 14:Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air
Standard in brief
Scope of Application：
本部分规定了湿性条件和干性条件微生物屏障试验的试验方法。
本部分给出的试验方法适用于最终灭菌医疗器械的包装材料。
Basic information
Standard No：YY/T 0681.14-2018
Standard Name：无菌医疗器械包装试验方法 第14部分：透气包装材料湿性和干性微生物屏障试验
English Name：Test methods for sterile medical device package—Part 14:Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air
Standard Status：现行
Release Date：2018-11-07
Effective Date：2019-11-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.080.040
CCS Number：C31
Related Standards
Referenced Standards：GB/T 450-2008,中华人民共和国药典(2015年版)
Publication Information
Number of pages：16
Number of words：22 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2018-11-01
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：0681.14
Drafter：王文庆、钱军、刘世梁、郝建新
Drafting Organization：山东省医疗器械产品质量检验中心、杜邦(中国)研发管理有限公司、司递卫贸易(上海)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
