IDC Medical Devices – MED75 Instrument Specifications

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  • This is a compact instrument designed for the high-speed testing of medical products in volume from several cubic-centimetres to several litres.
  • InterTech’s patented mass flow test technology results in a cost-effective solution to the requirements of high speed testing.
  • Touch-screen control panel, dual USB ports, Ethernet connectivity, and embedded Web page.
  • Up to 99 different test programs may be selected
  • Fail safe operation – Test pressure and mass flow transducer status are monitored during each test cycle to ensure correct operation of all components of the test circuit. Fault conditions are signalled by a red light, error message, and test record entry. The trouble contact output can be programmed to energize after a user selectable consecutive number of rejects
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New Technologies are helping medical device manufacturers solve challenging leak testing applications

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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.

Contact IDC re application details….

 

 

 

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FDA finalizes new system to identify medical devices

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FDA finalizes new system to identify medical devices

 The Food and Drug Administration (FDA) has released a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI.  This identifier includes production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label.  The InterTech Dev Co, MED75 family of leak detectors for the medical industry support the requirements of the new UDI ruling.  The units feature functions such as bar code reading and Ethernet IP communications capabilities that can provide seamless data transfer and part traceability.

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Roundtable Questions and Answers regarding Testing & Inspection in the Medical Device Industry

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Testing & Inspection in the Medical Device Industry

Some key questions addressed in this online session with Jacques Hoffmann include:

  • What are the common missteps OEMs make when planning a testing solution for their medical devices?
  • How early in the product development lifecycle should testing come into play?
  • When dealing with supply partners, what best practices should OEMs follow to inspect the product?
  • Any thoughts/comments on testing, inspection, or another related area that you would like to share with medical device manufacturers to aid them?

Check out this link for complete details on this session.

 

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