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Seal Performance Test Method of Sterile Drainage Catheters

May 04,2020

Source: Link Testing Instruments Co., Ltd

A sterile drainage catheter is a tube used to remove pus, blood or other fluids from a wound. They are commonly placed by surgeons or interventional radiologists. Drains inserted after surgery do not result in faster wound healing or prevent infection, but are sometimes necessary to drain body fluid which may accumulate and in itself become a focus of infection or retained blood complications.

The tube and its subassembly shall have sufficient seal performance. Otherwise some serious problems may occur. For example, the wound may become infectious due to the destruction of aseptic environment. If air is introduced into the chest tube, it may cause pneumothorax. As well cross-contamination may be caused by the leakage of fluid in the sterile drainage catheter. Therefore, it is necessary to check the seal performance of the sterile drainage catheter before use.

This article provides a simplified test method of seal performance of sterile drainage catheter for your reference. The testing instrument used for the tests is Link Testing’s LTY-01 Leak Tester.

Figure 1. Sterile drainage catheters

During the tests, the specimen is submerged in the water within the vacuum chamber, and then the vacuum chamber is evacuated to form differential pressure between the inside and outside of specimen. The leakage property could be obtained by observing the steady progression of bubbles from the specimen and how the specimen expands and restores to its original shape after vacuum release.

This test method conforms to YY 0489-2004: Sterile drainage catheters and accessory devices for single use and GB/T 15812.1-2005: Catheters other than intravascular catheters-Part1: Test methods for common properties.

The tests shall be performed according to the following procedures.

  • Assemble the sterile drainage catheter as required and plug the open end.
  • Place the sterile drainage catheter into the vacuum chamber of the instrument.
  • Set vacuum degree as required (the vacuum degree for the tests mentioned in this article is -90 KPa). The pressure maintaining time shall be 120 seconds.
  • Click Test to start the test. Observe the specimen surface and check if there are successive air bubbles coming out during the pressure maintaining time. When the time is up, the test will be ended automatically.

With the test results obtained in the tests mentioned above, the users can determine whether the sterile drainage catheters they tested can meet the requirements for clinical treatment. Only those products with good seal performance can be used.

Leak Tester LTY-01

For more details about LTY-01 Leak Tester, please visit www.linktesting.org

About Link Testing Instruments Co., Ltd:

Link Testing Instruments Co., Ltd is one leading supplier of packaging testing instruments, which is headquartered in Jinan, China.