YY/T 0681.3-2010
Active
T/CAMDI 009.2-2020
Active
Group standards
T/CAMDI 009.2-2020 Sterile packaging cleanliness for medical devices - Part 2: Microscopic contamination test method - Liquid washing extraction method
T/CAMDI 009.2-2020 Sterile packaging cleanliness for medical devices - Part 2: Microscopic contamination test method - Liquid washing extraction method
Price:
$ 20.00
Basic Information
Standard Code:
T/CAMDI 009.2-2020
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Disinfection and packaging
Publish Date:
2020-12-31
Implement Date:
2020-12-31
Scope
Main technical content: This document describes the test method for particulate contamination in the primary packaging of sterile medical devices: the liquid elution method. This document is applicable to sterile medical devices with irregular surfaces, such as blister packs and containers in their primary packaging.
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