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  • Medical Device Link .
    of the test equipment available. The limited dynamic range of conventional helium leak detectors required that a secondary test procedure be developed to cover the large, or gross, leak range. Several methods have been tried, and the most commonly used procedure, referred to as the bubble test, involves
  • Medical Device Link .
    , burst and tensile seal-strength tests and bubble or dye leak integrity tests). � Recognition by FDA in regulations
  • Medical Device Link .
    struggle with the possibility of false-positive results when performing sterile integrity testing (bubble-leak or dye-penetration tests) on a flexible sterile barrier system (SBS) containing porous materials. A false positive can occur when a flexible pouch containing a porous material is bent, folded

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