YY/T 0681.5-2010 Translated English of Chinese Standard (YY/T 0681.5-2010, YYT0681.5-2010): Test methods for sterile medical device package. Part 5: Detecting gross leaks in medical packaging by internal pressurization (bubble test)

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https://www.chinesestandard.net, Apr 24, 2023 - Medical - 13 pages
This Part of YY/T 0681 covers the inspection of gross leaks in medical packaging. The sensitivity of the method has a detection probability of 81% for pore sizes above 250 ??m (see Annex B). This test method can be used for pallet and multi-bag packaging. This test method evaluates sensitivity only for spunbond polyolefin or non-breathable packaging. The sensitivity of other packages with gas permeable materials is not evaluated. This method is a destructive test. In the test, it is necessary to inject air into the package to form internal pressure.
 

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Contents

Foreword
3
Scope
4
Meaning and application
5
Sampling
6
Report
8
Annex A normative Determination of test pressure
9
Annex B informative Precision and bias
12

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