A unique aspect of medical devices is that many of them are made from flexible materials. Every leak testing method is based on creating or reducing gas pressure inside or outside an assembly. However, if you pressurize a blood bag, for example, it will simply expand like a balloon. Pressurize it too much, and it will burst. Pull a vacuum on it, and it will collapse.
Another option, at least for sealed packages, is to place the package in a sealed chamber and reduce the pressure by a small amount.
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