YY/T 0681.3-2010
Active
T/CAMDI 009.10-2024
Active
Group standards
T/CAMDI 009.10-2024 Sterile Medical Device Initial Packaging Cleanliness - Part 10: Limit of Contamination
T/CAMDI 009.10-2024 Sterile Medical Device Initial Packaging Cleanliness - Part 10: Limit of Contamination
Price:
$ 20.00
Basic Information
Standard Code:
T/CAMDI 009.10-2024
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Disinfection and packaging
Publish Date:
2024-01-02
Implement Date:
2024-01-03
Scope
Main technical content: This document specifies the pollution limit requirements for the cleanliness of primary packaging and/or primary packaging materials of sterile medical devices according to the T/CAMDI 009 series standard test. This document is applicable to manufacturers of primary packaging and/or primary packaging materials of sterile medical devices, and also to manufacturers of sterile medical devices.
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