This part of YY/T 0681 is applicable to determine the penetration resistance of the anti-drive probe of flexible barrier film and laminates. In this test, biaxial stress is applied to the material at a constant test rate at room temperature, until penetration occurs; the force, energy and elongation before penetration are measured. Note: Appendix A gives the precision and bias of the test methods as specified in this part.
Basic Data
Standard ID
YY/T 0681.13-2014 (YY/T0681.13-2014)
Description (Translated English)
Test methods for sterile medical device package. Part 13: Slow rate penetration resistance of flexible barrier films and laminates
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C31
Classification of International Standard
11.080.040
Word Count Estimation
11,157
Date of Issue
6/17/2014
Date of Implementation
7/1/2015
Quoted Standard
GB/T 2918
Adopted Standard
ASTM F1306-1990, 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 the determination of flexible barrier films and composite membranes expose anti-driven nature of the probe. This Standard specifies the room temperature at a constant rate test biaxial stress exerted on the material until the punc
