TechTalk: Product & Packaging Testing to Support Medical Devices
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Join Our Mailing ListEnsuring that a medical device and its packaging are safe and perform effectively is crucial when guiding product development, regulatory compliance, and marketing efforts. Nate Wilhelm, Packaging Testing Manager at STERIS Applied Sterilization Technologies (AST), outlines essential tests for validating sterility of a medical device’s packaging and explains when to use each test. Then, Phillip Roxby, Technical Services Manager at STERIS AST, discusses a variety of tests for assessment of medical devices.
30.31
Sterile Packaging Testing
1:23 – Why Test?
2:51 – Which Test Method?
7:48 – Distribution Testing
9:08 – Stability & Aging
11:39 – Strength & Integrity
13:28 – Bubble Leak
14:00 – Dye Penetration
14:21 – Peel Testing
Medical Device Testing
17:31 – Test Method Validation (TMV)
22:19 – Device Testing Example
26:16 – Catheter Balloon Burst Test
26:44 – Force to Deploy
27:44 – Luer Connector Compliance
28:32 – Biocompatibility