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ASTM Names New Standard for Raw Materials

The standard will also be used by manufacturers and suppliers to set internal specifications for their products. This is especially helpful for suppliers, because specifications based on a recognized standard tend to be more consistent, which reduces the need for them to conduct special tests for a single customer.

What will manufacturers and suppliers need to do to comply with the new standard?

Moseley: Suppliers of PEKK resins will have to perform testing to verify the identity and purity of the polymer; to show that physical properties such as density, melting point and glass transition temperature are within narrow limits; and that mechanical properties such as tensile and impact strength meet specifications when the resin is fabricated into standard test specimens.

Manufacturers of medical devices will also have to show that their products still meet the physical and mechanical requirements of the standard after all process steps have been completed. Testing has to be performed on the final device (or on test specimens fabricated according to identical methods), because each process step has the potential to adversely affect the material. For example, gamma or e-beam radiation is frequently used to terminally sterilize medical devices, and ionizing radiation can cause degradation in many polymers.

In addition to setting requirements for the properties of PEKK, F2820 also stipulates that both the resin and fabricated forms should be manufactured under a certified Quality Management System.

What else should orthopaedic manufacturers and suppliers know about ASTM F2820?

Moseley: All standards should be considered as works in progress, and this is especially true of new standards. Subcommittee F04.11 welcomes feedback and participation in the ongoing effort to improve the quality and usefulness of the standards under its jurisdiction.

 

Jon Moseley, Ph.D., earned degrees in chemical and biomedical engineering and has worked in the medical device industry for more than 20 years. He is the Director of Implant Technology for Wright Medical Technology, an orthopaedics company located in Arlington, Tennessee. He also serves as chairman for ASTM subcommittee F04.11 on polymeric materials for surgical and medical devices. He can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..

 

Photo Courtesy of Oxford Performance Materials


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