YY/T 0681.3-2010
Active
YY/T 0681.10-2011
Active
Industry standards-Medicine
YY/T 0681.10-2011 Test methods for sterile medical device package—Part 10:Test for microbial barrier ranking of porous package material
YY/T 0681.10-2011 Test methods for sterile medical device package—Part 10:Test for microbial barrier ranking of porous package material
Basic Information
Standard Code:
YY/T 0681.10-2011
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:
2011-12-31
Implement Date:
2013-06-01
Pages:
17 pages
Scope
The test method specified in this part is used to determine the penetration of airborne bacteria into the breathable materials used for packaging sterile medical devices. This test method is designed to test the materials under the condition that bacterial spores can penetrate the test materials, so as to grade the materials.
This test method requires the handling of microorganisms and can only be carried out by trained personnel.
Note: The information on the precision and bias of this test method is provided in Appendix B.
Development Information
Same series standard
YY/T 0681.6-2011 Test methods for sterile medical device package—Part 6：Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials
YY/T 0681.7-2011 Test methods for sterile medical device package—Part 7:Evaluating inks or coating adhesion to flexible packaging materials using tape
YY/T 0681.8-2011 Test methods for sterile medical device package—Part 8:Coating/adhesive weight determination
YY/T 0681.9-2011 Test methods for sterile medical device package—Part 9:Burst testing of flexible package seals using internal air pressurization weight restraining plates
Referenced Standards
Adopt standards
ASTM F 1608-00
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
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