Medical devices continue to innovate and are available in a wide range of complex shapes and packaging materials. They vary from porous flexible packaging to non-porous rigid containers. Of these, the class III medical devices require higher safety conditions as they present a potential risk of illness and injury.
Non-compliant balloon catheters are an excellent example of a leak-testing solution. It is equipped with inflatable balloons to approach blockages, dilation, or stent delivery.
The balloon is inflated to a set diameter depending on if it is stented or not. For most applications, non-stented catheters undergo pressure decay testing while stented catheters undergo low-pressure/ vacuum decay testing.
Laparoscopy/endoscopy devices and respiratory devices are a few medical device assemblies that require multi-step leak detection. Its complex structure and the presence of multiple seals require leak testing at different points in the assembly.
Devices such as catheters, ventilatory systems, pacemakers, breast implants, plugs/caps, urine, and disposable bags, syringes, etc. are other most tested medical devices for their leak and product reliability. The pressure decay leak testing method is the most widely preferred test method.
