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YY/T 0681.5-2010 English PDF (YYT0681.5-2010)

YY/T 0681.5-2010 English PDF (YYT0681.5-2010)

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