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)

Scope

This part of YY/T 0681 covers the testing of gross leaks in medical packaging. The sensitivity of the method is 81% for the detection of pores with a diameter of more than 250 μm (see Appendix B). This test method can be used for tray and composite bag packaging.
This test method only evaluates the sensitivity of spunbonded polyolefin or non-breathable packaging, and does not evaluate the sensitivity of packaging with breathable materials.
This method is a destructive test, and during the test, air needs to be injected into the packaging to create internal pressure.

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