Biocompatibility

Biocompatibility

Plastics have many unique properties in terms of their manufacturability and production possibilities, and these are being increasingly utilized in the production of medical devices and medical packaging. The Medical Device Industry is one of the fastest growing areas for plastics, with growth rates exceeding GDP growth for several years. This trend is predicted to continue into the future with the aging population, improvements in plastics technology (both materials and processing), and the development of increasingly innovative medical devices.

Despite this significant growth, one thing remains constant. The application of any material in a medical device must continue to meet stringent requirements:

  • It must be biocompatible to the levels required for the specific use.
  • It must comply with complex legislative and regulatory requirements.
  • It must comply with environmental regulations.

Biocompatibility at Zeus
Zeus is proud to offer USP Class VI approval certification with each order in response to the unique requirements of the Medical Device Manufacturing community.

The following resins are USP Class VI tested by independent laboratories, which are used in Medical, Diagnostic, and Analytical applications consisting of extruded tubing, heat shrink tubing, profiles and multi-lumens.

  • PTFE Polytetrafluoroethylene
  • FEP Fluorinatedethylenepropylene
  • PFA Perfluoroalkoxy
  • ETFE Ethylenetetrafluoroethylene
  • PEEK Polyetheretherketone

In addition, Zeus has USP Class VI tests for some pigments and compounds used in conjunction with USP Class VI tested resins.

Zeus certifies the resins and pigments meet the following USP Plastics Class 6 requirements:

Biological Reactivity USP XXII

  • Systemic Injection (Acute Systemic Toxicity, Mice)
  • Intracutaneous Test (Intracutaneous Toxicity, Rabbits)
  • Implantation Test (Implant, Rabbits)
In addition to the extensive testing Zeus does on their resins, we offer 100 percent traceability on all your orders.

Request Samples and Tech Info
If you would like samples of our fluoropolymer or other engineered tubing, or would like to discuss a specific application, we'd like to talk with you. Zeus has a generous sample program, making it easier than ever for engineers and designers to get stock and custom samples quickly.

Need More Information?

Contact us now to evaluate samples of our extruded tubing or request a quote. To locate regional distributors, contact a technical account manager at 1.800.526.3842 or 1.803.268.9500.

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