BT Integra configured to test Medical Device for Leak Flow and Occlusion

Medical Device & Packaging Testers

We offers a range of instruments designed to help you test both medical devices and device packaging for leak, flow, creep, burst, occlusion, seal integrity, sterile barrier maintenance (ISO 11607), and bubble leak (F2096). TME instruments are used in all stages of product development and quality control testing. 

Systems calibration is NIST traceable. Data security is FDA 21 CFR  Part 11 compliant.

The instruments are designed to conform to all applicable ASTM International testing methods.

Examples of some of the medical devices tested with our instruments:

  • Catheters
  • Trocars
  • Intravenous infusion sets
  • Blood devices
  • Filters
  • Blood and drainage bags
  • Bottles
  • Implantable devices
  • Solution vials
  • Package integrity
  • Tubing and connectors
  • Pouches of any size
  • Blister packs

We have ability to design and manufacture custom test fittings to solving unique testing challenges.

Examples (not limited to) of custom test fittings:

Catheter Tester Blister Pack Tester Trocar Tester