Plastics have many unique properties in terms of their manufacturability and production possibilities that make them especially amenable to medical applications. There is an extensive and successful history of medical use for a number of polymer plastics because of their chemical inertness, non-toxic character, and their ability to be used for prolonged contact with human and animal tissue.
With such a proven record of success, the medical industry has greatly expanded its pursuit of plastics with biocompatible qualities for medical devices as well as packaging. This 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 in light of our aging population. Supporting the industry’s growth are substantial 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: The device must be biocompatible to the levels required for its specific use; it must comply with complicated legislative and regulatory requirements; and the device must conform to environmental regulations.
Biocompatibility at Zeus
At Zeus, we are 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. These products include extruded tubing, heat shrink tubing, profiles, and multi-lumens.
- PTFE (polytetrafluoroethylene)
- FEP (fluorinated ethylenepropylene)
- PFA (perfluoroalkoxy)
- ETFE (ethylene tetrafluoroethylene)
- PEEK (polyether ether ketone)
We also have 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 VI 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 that we do on vendor resins, we offer 100% traceability on all your orders.