YY/T 0681.3-2010
Active
T/CAMDI 009.10-2023
Active
Group standards
T/CAMDI 009.10-2023 Sterile Medical Device Initial Packaging Cleanliness - Part 10: Limit of Contamination
T/CAMDI 009.10-2023 Sterile Medical Device Initial Packaging Cleanliness - Part 10: Limit of Contamination
Price:
$ 20.00
Basic Information
Standard Code:
T/CAMDI 009.10-2023
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Disinfection and packaging
Publish Date:
2023-04-20
Implement Date:
2023-04-20
Pages:
7 pages
Scope
Main technical content: The primary packaging of sterile medical devices is an integral part of sterile medical devices, so its cleanliness directly affects the cleanliness of sterile medical devices. This requires that the primary packaging be produced under sufficiently clean conditions. For the primary packaging of certain special devices, it may be required to be produced in a production environment with the same cleanliness as that of sterile medical devices, or to undergo final cleaning. The cleanliness of the primary packaging of sterile medical devices can be evaluated from the following aspects: — Particle contaminants; — Microbial load; — Bacterial endotoxins
Development Information
Same series standard
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