《YY/T 0681.5-2010Test Methods for Aseptic Medical Device Packaging5Part: Internal pressure method for detecting large leaks (bubble method) ", detecting large leaks in medical packaging.

Method sensitivity250μmThe detection probability of the above aperture is81%This method can be used for tray and combination bag packaging.

Testing instruments:

Test method:

Experimental MethodA---Procedure for non breathable packaging

1Use a puncher (such as a small slotted screwdriver or other suitable device) to pierce an empty space on the packaging. In order to insert the air source and pressure monitor into the sample. Perforation should be located in the center of the packaging as much as possible. The size of the hole should be suitable for inserting an air source and pressure monitor, and minimize air leakage. If necessary, use tape and rubber pads as a plug for the perforated area to seal the insertion site.

2Insert an air source and pressure monitor into the test sample. Immerse the packaging underwater for approximately2.5cmApply air to the packaging. (Using a limiter will help keep the entire package at the appropriate depth)

3If necessary, adjust the gas and pressure limiting valve and slowly inflate the packaging to a level greater than or equal to that specified in the appendixAThe determined small experimental pressure. If necessary, adjust the pressure limiting valve and pressure regulator to maintain a constant pressure.

4Inspect the bubble flow in areas showing damage (sealed passages, pinholes, ruptures, tears, etc.) on the entire packaging, and the inspection time depends on the size of the packaging.

5Remove the packaging from the water and mark all observed damaged areas.

Experimental MethodB---Procedure for breathable packaging

1Use a puncher (such as a small slotted screwdriver or other suitable device) to pierce an empty space on the packaging. In order to insert the air source and pressure monitor into the sample. Perforation should be located in the center of the packaging as much as possible. The size of the hole should be suitable for inserting an air source and pressure monitor, and minimize air leakage. If necessary, use tape and rubber pads as a plug for the perforated area to seal the insertion site.

2Insert an air source and pressure monitor into the test sample. Immerse the packaging underwater for approximately2.5cmAnd maintain at least5sApply air to the packaging. (Using a limiter will help keep the entire package at the appropriate depth)

3If necessary, adjust the gas and pressure limiting valve and slowly inflate the packaging to a level greater than or equal to that specified in the appendixAThe determined small experimental pressure. If necessary, adjust the pressure limiting valve and pressure regulator to maintain a constant pressure.

4Inspect the bubble flow in areas showing damage (sealed passages, pinholes, ruptures, tears, etc.) on the entire packaging, and the inspection time depends on the size of the packaging.

5Remove the packaging from the water and mark all observed damaged areas.

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