YY/T 0681.3-2010
Active
YY/T 0681.4-2021
Active
Industry standards-Medicine
YY/T 0681.4-2021 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration
YY/T 0681.4-2021 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration
Price:
$ 48
Basic Information
Standard Code:
YY/T 0681.4-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Disinfection and packaging
Publish Date:
2021-03-09
Implement Date:
2022-04-01
Pages:
12 pages
Scope
This part of YY/T 0681 specifies the test method for determining the sealing leakage of breathable packaging by the dye penetration method.
This part is applicable to the detection of channels larger than or equal to 50 μm in the sealing of packaging composed of transparent materials and breathable materials.
This part is not applicable to breathable materials that stain due to capillary action within 5 seconds, nor to situations where the contrast between the dye and non-transparent materials is not significant.
Development Information
Replace the following standards
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