YY/T 0681.3-2010
Active
YY/T 0681.4-2021
Active
Industry standards-Medicine
YY/T 0681.4-2021 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration
YY/T 0681.4-2021 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration
Basic Information
Standard Code:
YY/T 0681.4-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Disinfection and packaging
Publish Date:
2021-03-09
Implement Date:
2022-04-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医用输液器具标准化技术委员会(SAC/TC 106)
Pages:
12 pages
Scope
YY/T 0681的本部分规定了通过染色液穿透法测定透气包装密封泄漏的试验方法。
本部分适用于检测透明材料和透气材料组成的包装密封处大于或等于50 μm的通道。
本部分不适用于5 s内因毛细作用出现染色的透气材料，也不适用于染色液同不透明材料反差不大的情况。
Development Information
Drafting Units:
山东省医疗器械产品质量检验中心、明尼苏达矿业制造医用器材(上海)有限公司、河南亚都实业有限公司、山东百多安医疗器械股份有限公司、山东康力医疗器械科技有限公司
Drafting Persons:
王冬伟、郑阳、张祥龙、段书霞、张静、张海军、熊巍、刘壮
Replace the following standards
Related Standards
YY/T 0681.4-2010
Replaced
YY/T 0681.4-2010 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration
YY/T 0681.10-2011
Active
YY/T 0681.10-2011 Test methods for sterile medical device package—Part 10:Test for microbial barrier ranking of porous package material
GB/T 19633.1-2015
Active
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.2-2015
Active
GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes
YY/T 0681.14-2018
Active