YY/T 0681.2-2010: Test methods for sterile medical device package. Part 2: Seal strength of flexible battier materials

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Scope

This Part of YY/T 0681 covers the measurement of the seal strength of flexible barrier
materials.
This test can be used to test the seal, between flexible and rigid materials.
Sealed samples, which comply with this test method, may come from any source,
EITHER formed in the laboratory OR from commercial sources.
This test method can measure the separation force, which is required to seal the
specimen, AND also identify the type of specimen failure.
Note. Appendix C and Appendix D respectively give the precision and bias of the test methods,
which are specified in this standard, as well as the relevant information for their determination.

Basic Data

Standard ID	YY/T 0681.2-2010 (YY/T0681.2-2010)
Description (Translated English)	Test methods for sterile medical device package. Part 2: Seal strength of flexible battier materials
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Classification of International Standard	11.080.40
Word Count Estimation	18,180
Date of Issue	2010-12-27
Date of Implementation	2012-06-01
Quoted Standard	GB/T 2918
Adopted Standard	ASTM F88-2006, 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 flexible barrier material seal strength measurements. This test can be flexible material and rigid material seal between the test. Meet this test method, the samples may come from any source that can form in the laboratory, can also come from the product. This test method measures the separation force required to seal the sample, but also identify the type of sample damage.