This part of YY/T 0681 includes the determination of the flex durability of flexible barrier films. In this test method, the formation of pinhole is used as the criterion for determining the damage. Other tests such as gas transmission may also be used instead of pinhole tests. Note. Appendix A gives the precision and bias of the test methods as specified in this standard.
Basic Data
Standard ID
YY/T 0681.12-2014 (YY/T0681.12-2014)
Description (Translated English)
Test methods for sterile medical device package. Part 12: Flex durability of flexible barrier films
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C31
Classification of International Standard
11.080.040
Word Count Estimation
9,966
Date of Issue
6/17/2014
Date of Implementation
7/1/2015
Quoted Standard
GB/T 2918
Adopted Standard
ASTM F392-1993, NEQ
Regulation (derived from)
China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies)
State Food and Drug Administration
Summary
This Standard applies to pinhole formation damage as determined whether or not the judge in the final sterilization packaging. This Standard specifies the test method for the determination of anti-rub soft barrier film properties.
