YY/T 0681.3-2010
Active
T/CAMDI 082-2022
Active
Group standards
T/CAMDI 082-2022 Guidelines for verifying packaging test methods
T/CAMDI 082-2022 Guidelines for verifying packaging test methods
Price:
$ 20.00
Basic Information
Standard Code:
T/CAMDI 082-2022
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Disinfection and packaging
Publish Date:
2022-12-22
Implement Date:
2023-07-01
Scope
Main technical content: The information provided in this document aims to clarify the process of confirming packaging test methods used by institutions through inter-laboratory studies (ILS), resolve consensus standards for inter-laboratory studies in institutions, and address specific methods. This document provides guidance for defining and developing methods for confirming the application of measurement-based and count-based data. This document is applicable to the confirmation of packaging test methods in the medical device and packaging industries.
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