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New polyurethane grades meet FDA modified regulation

June 27, 2007 By Kathleen Zipp

Bayer MaterialScience LLC developed Texin thermoplastic polyurethane (TPU) grades to meet the FDA-modified ISO 10993 Part 1, “Biological Evaluation of Medical Devices‚” tests with human tissue contact time of 30 days or less. Properties of these grades include: excellent clarity for visual observation; chemical and lipid resistance, high abrasion, wear, tear, and stain resistance; mold, fungi, and algae resistance; and low extractables, especially compared with polyvinyl chloride.

The grades also have decreased risk of allergic reactions and are radiation, ethylene oxide, and can be sterilized with dry heat. The TPU's are suited for a wide range of medical applications, including catheters; flexible, thin-walled, kink-resistant tubing; connectors, luers, and stopcocks. Other ideal applications include: puncture-resistant films and fabric coatings for breathable gowns, linens, and wound dressings.

Bayer MaterialScience LLC
www.bayermaterialscienceNAFTA.com

:: Design World ::

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  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
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    • Digital Editions
    • eBooks
    • Manufacturer Search
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    • Print Subscription
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    • Whitepapers
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