ISO 10993-1 and Biocompatibility for Medical Devices

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Biocompatibility testing: an intimidating, time-consuming, and, at times, very expensive requirement in most major medical device markets. Biocompatibility testing is the systematic evaluation of a product's biological safety to avoid any risk of bio-incompatibility with the human body.

If you are marketing a device in Europe, the US, or even beyond, the ISO 10993 series is your guide to biocompatibility testing requirements. It provides guidelines and requirements for manufacturers to appropriately mitigate the biological risks up to and including testing to confirm biocompatibility.

In this white paper, we answer your biggest questions about the biocompatibility testing requirements of ISO 10993, including:

  • What are the basics of implementing a testing program?
  • How do you interpret test results?
  • What are the elements of a biological evaluation plan? Of a biological evaluation report?
  • How to select and characterize materials?
  • What are the different types of biological tests?
  • How do you determine the appropriate tests for your device?
  • How much does testing cost and how long does it take?

Get answers to all of these questions and more in this white paper.

About the Author:

Alexandre Pétiard
Alexandre is Senior QA/RA Consultant in France.