Importance of leak testing in Medical devices

Medical devices unlike other mass produced products needs to undergo strict testing methods. The quality standard has become stringent due to the availability of new testing techniques.  Medical products like blood filters, catheters, diagnostic probes, syringes, ventilator tubes and other items need to pass through the criteria set by the Food and Drug Administration. Testing for leak cohesion is especially mandatory in the medical field, failure of a product due to poor testing can be life-threatening for patients and can attract liabilities for the manufacturing company.

Leak testing of high accuracy, sensitivity, repeatability and reproducibility with critical inspecting methods is of high importance. Medical devices have a system to carry fluids or gases hence, they require 100% accurate leak proof testing. Thebarriers must function effectively to protect the patient andthe medical device itself. Some devices serve as a pathwaythat delivers or extracts fluid to or from a precise location in the body. If a leak exists along the pathway, fluids could be accidentally delivered to the wrong location, or the wrong fluids could be extracted, inciting dangerous consequences.

Testing Methods

Leak testing testifies the quality of a product. Various test methods include pressure testing, pressure decay, bubble break point testing and destructive burst testing.

Testing equipment are used to detect a variety of flaws like gross leaks, fine leaks, blockage, cracks in seals, crimped lines, rolled seals, kinked hoses, and defective valves and pressure regulators.

Leaks tests are classified into the following basic two categories:

1. The product is pressurized, isolated from the pressure source, and observed to detect escaping gas. Bubble, sniff, pressure decay, differential pressure, mass flow and mass spectrometry testing fall into this category.

2. In this method, the product is evacuated and then monitored to see if gas flows into it. Pressure rise and mass spectrometry are in this category.

Challenges in Leak Testing

Engineers face various challenges while testing medical devices. For example, a major factor in successful leak testing is correct clamping and sealing of the test piece. Medical devices frequently have small slits and multiple transfer paths to test.
Many medical devices include flexible components that are completely made of flexible material. This creates difficulties with testing because of fluctuations in volume created by the distortion of the flexible material.

According to survey, ventilator parts are the most challenging medical devices to test, because precise multiple pressures are required to test each part.
It becomes the most difficult to do a leak testing when several sequential tests are required. For example, catheters usually require a sequence of leak and flow tests on several lumens.


The important leak testing requirements are reliability,the ability to challenge the test and the extent of validation. Demand for high accuracy leak test at lower cost and higher production rates have increased. Growing innovation in non-invasive surgery has brought more minute products in market whose testing needs to be more precise. We at Mikro Innotech India Pvt Ltd. provide high accuracy leak test to major brands across India. Contact us for more details.