The test method specified in this Part of YY/T 0681 covers the determination of channels in the package seal down to a width of 75 μm with a 60 % ~ 100 % probability (see Appendix B). This test method is applicable to flexible and rigid packages with at least one transparent side, so that the seal area may be clearly viewed.
Basic Data
Standard ID
YY/T 0681.11-2014 (YY/T0681.11-2014)
Description (Translated English)
Test methods for sterile medical device package. Part 11: Determining integrity of seals for medical packaging by visual inspection
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C31
Classification of International Standard
11.080.040
Word Count Estimation
11,186
Date of Issue
6/17/2014
Date of Implementation
7/1/2015
Quoted Standard
ASME F 17
Adopted Standard
ASTM F1886-1998, 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 at least one side of the transparent terminal sterilization of soft and hard materials, packaging materials, packaging. This Standard specifies the ability of 60% to 100% probability, test methods to determine the width of the cha
