YY/T 0681.3-2010
Active
GB/T 19633.2-2024
Active
National standards
GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes
GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes
Basic Information
Standard Code:
GB/T 19633.2-2024
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Disinfection and packaging
Publish Date:
2024-05-28
Implement Date:
2025-12-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
全国消毒技术与设备标准化技术委员会(SAC/TC 200)
Pages:
18 pages
Scope
本文件规定了最终灭菌医疗器械包装过程的开发和确认要求。这些过程包括了预成型无菌屏障系统、无菌屏障系统和包装系统的成型、密封和装配。本文件不适用于无菌制造医疗器械的包装。对于药物与器械的组合，还可能有其他要求。
Development Information
Drafting Units:
广东省医疗器械质量监督检验所、上海微创医疗器械(集团)有限公司、杜邦(中国)研发管理有限公司、南微医学科技股份有限公司、上海建中医疗器械包装股份有限公司、安姆科集团毕玛时软包装(苏州)有限公司
Drafting Persons:
万易易、李然、秦蕾、丁艳琴、汪友琼、钱军、王芳颖、袁碧钰、李勇、李宁、宋翌勤、王清
Same series standard
Replace the following standards
Referenced Standards
Adopt standards
ISO 11607-2:2019
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