YY/T0681.5-2010Test Methods for Aseptic Medical Device Packaging 第5part:Internal pressure method for detecting large leaks(Bubble method)》Mainly used for detecting large leaks in sterile medical device packaging. The following is a detailed explanation of the testing method:

This standard belongs toYY/T0681Part of the series of standards, focusing on the internal pressure method(Bubble method)To detect large leaks in sterile medical device packaging. This method is suitable for tray and combination bag packaging, especially for evaluating the sensitivity of spunbond polyolefin or non breathable packaging.

Keywords: Internal pressure tester, coarse bubble sealing tester, positive pressure sealing tester, leakage and sealing strength tester, sealing tester

1、 Testing principle

Inflate the packaging underwater to a predetermined pressure and observe for a continuous stream of bubbles indicating packaging damage.

Instrument recommendation:Jinan ZhongnuoMFY-06ALeakage and sealing strength tester

2、 Test steps

Perforation and Insertion:Use a puncher to make a hole in the packaging for inserting an air source and pressure monitor. The perforation should be located in the center of the packaging, and the size of the hole should be suitable for insertion and minimize air leakage.

Inflation and observation:Immerse the packaging underwater for approximately2.5cmThen slowly inflate the packaging to the predetermined pressure. Observe whether there is a continuous flow of bubbles on the packaging to determine if there is a large leak.

3、 Meaning and Application

1.Purpose: This test method is used to detect large leaks on sterile medical device packaging that may cause the product to be unable to maintain a sterile state.

2.Application scenarios:Suitable for sterile medical device packaging such as trays and combination bags. Specially suitable for detecting large leaks in spunbond polyolefins or non breathable packaging.

3.重要性:The integrity of packaging is crucial for ensuring the safety of sterile medical devices. Through this experimental method, defects on the packaging can be detected and repaired in a timely manner, ensuring the sterile state of the product.

YY/T0681.5-2010Test Methods for Aseptic Medical Device Packaging5part:Internal pressure method for detecting large leaks(Bubble method)》It is an effective method for testing sterile medical device packaging. It can detect large leaks on the packaging and ensure the sterility of the product by observing the flow of bubbles through underwater inflation. When using this method, attention should be paid to the pressurization method and pressure control to ensure the accuracy and reliability of the test results