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
Price:
$ 75
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
Pages:
18 pages
Scope
This document specifies the development and validation requirements for the final sterilization of medical device packaging processes. These processes include the pre-molding of sterile barrier systems, the molding, sealing, and assembly of sterile barrier systems and packaging systems. This document does not apply to the packaging of sterile-manufactured medical devices. For drug-device combinations, there may be additional requirements.
Development Information
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