Testing Medical Device and Package Integrity - TM …

Testing Medical Device and Package Integrity Authors: Michael Franks, Stephen Franks - Electronics, Inc. 1999 Table of Contents Introduction: Objective Medical Device Testing : Step 1 Process Validation Planning Step 2 - Choosing the Testing Methodologies Leak Integrity Testing Methods Flow Integrity Testing Methods Step 3a - Pressure Decay Leak and Mass Flow Testing Pressure Decay Leak Testing Specifications Mass Flow Testing for Leakage Step 3b - Mass Flow Testing for Obstructions Mass Flow Testing Step 4 - Product Assurance Package Validation Testing : Step 1 Package Validation Planning Step 2 Choosing the Package Testing Methodologies Tensile Seal Strength Testing Inflation Seal Strength Step 3a. Inflation Test Specifications Burst Testing Creep Testing Creep to Failure Testing Step 3b.

be aware of different testing methodologies in order to gain this control and assurance over the production and packaging processes. This report examines different product and

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  Devices, Medical, Testing, Packages, Integrity, Testing medical device and package integrity

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