Assessing Biocompatibility

To demonstrate the safety and efficacy of their products, medical device manufacturers use data from a variety of analytical, in vitro, and animal test procedures. The ISO 10993 guidelines spell out the requirements for basic biocompatibility testing of medical devices.

This section consists of content from the booklet “Assessing Biocompatibility” which has helped hundreds of device designers and manufacturers plan and implement their biocompatibility testing programs. (We’re proud to note that a version of Assessing Biocompatibility was published as a chapter in The Medical Device R&D Handbook by Theodore R. Kucklick.)

For an overview of basic biocompatibility terms and concepts go to the Introduction to biocompatibility testing.

If you are already familiar with basic concepts go straight to the PBL BioPT, a tool for quickly locating the content that you most need to proceed with planning your biocompatibility test program.

The Biological test methods section gives a brief description of various test methods used for biocompatibility testing.

Finally, to learn about strategies for material characterization and the importance of understanding the nature of the materials used in a device, visit the section on Analytical Testing of Materials.

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