YY/T 0681.3-2010
Active
T/CAMDI 009-2018
Active
Group standards
T/CAMDI 009-2018 Sterile medical device packaging Part 1: Micro particle testing methods
T/CAMDI 009-2018 Sterile medical device packaging Part 1: Micro particle testing methods
Price:
$ 20.00
Basic Information
Standard Code:
T/CAMDI 009-2018
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Disinfection and packaging
Publish Date:
2018-03-01
Implement Date:
2018-07-01
Scope
Main technical content: This standard specifies the method for inspecting particulate contamination in the primary packaging and primary packaging materials of sterile medical devices. This standard is applicable to the inspection of particulate contamination in the primary packaging and primary packaging materials of sterile medical devices.
Development Information
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