This Part of YY/T 0681 specifies the procedure for determining the ability of packages to withstand internal pressurization. The burst test is to gradually pressurize the package until the package fails. The creep test maintains a specified pressure for a specified time or until the package fails. Note. Appendix A gives the relevant information of the precision and bias of the test methods specified in this Standard.
Basic Data
Standard ID
YY/T 0681.3-2010 (YY/T0681.3-2010)
Description (Translated English)
Test methods for sterile medical device package. Part 3: Internal pressurization failure resistance of unrestrained packages
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C31
Classification of International Standard
11.080.40
Word Count Estimation
10,174
Date of Issue
2010-12-27
Date of Implementation
2012-06-01
Quoted Standard
GB/T 2918; YY/T 0681.2
Adopted Standard
ASTM F1140-2007, MOD
Regulation (derived from)
State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the ability to withstand the internal pressure was measured packing procedures. Bursting test was gradually pressurized inside the packaging until the package damage. Creep test was applied to a predetermined pressure and maintaining a predetermined time or until the package damage.
