YY/T 0681.3-2010
Active
YY/T 0681.4-2010
Replaced
Industry standards-Medicine
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 0681.4-2010 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration
Basic Information
Standard Code:
YY/T 0681.4-2010
Standard Type:
Industry standards
Standard Status:
Replaced
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Disinfection and packaging
Publish Date:
2010-12-27
Implement Date:
2012-06-01
Pages:
7 pages
Scope
This part of YY/T 0681 specifies the method for detecting channels greater than or equal to 50 μm in the sealed edge formed by silk threads between transparent films and breathable materials, and identifying the materials and procedures used to locate the channels. A dyeing solution is applied locally to the sealed edge for leakage testing. After a specified period of contact with the dyeing solution, the dye penetration on the packaging is visually inspected.
This test method is intended for the inspection of the sealed edges formed between transparent films and breathable materials. This test method is only applicable to breathable materials that can retain the dyeing solution and do not cause the entire sealed area to discolor within a minimum time of 20 seconds. Uncoated paper is particularly susceptible to dye penetration and must be carefully evaluated when using this test method.
This test method requires that non-transparent packaging materials provide good contrast for the dyeing solution.
Development Information
Same series standard
YY/T 0681.2-2010 Test methods for sterile medical device package—Part 2:Seal strength of flexible battier materials
YY/T 0681.3-2010 Test methods for sterile medical device package—Part 3:Internal pressurization failure resistance of unrestrained packages
YY/T 0681.5-2010 Test methods for sterile medical device package—Part 5:Detecting gross leaks in medical packaging by internal pressurization(bubble test)
Superseded by the following standards
Adopt standards
ASTM F 1929-1998
Related Standards
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
YY/T 0681.14-2018 Test methods for sterile medical device package—Part 14:Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air
YY/T 0681.4-2021
Active