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Regulatory biocompatibility requirements for biomaterials used in regenerative medicine

  • David F. Williams
Special Issue: ESB 2014 Biocompatibility Studies
Part of the following topical collections:
  1. Special Issue: ESB 2014

Abstract

The biological safety of biomaterials used for implantable medical devices is usually determined by a series of standard tests that assess the effects that extractable substances have on cells in vitro and in simple short term animal studies. To use these tests to determine the suitability of materials for tissue engineering templates is inappropriate. This short essay discusses the issues that are involved.

Keywords

Tissue Engineering Medical Device International Standard Organization Implantable Device Biological Safety 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

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    International Standards Organization, biological evaluation of medical devices, part 1 evaluation and testing, ISO 10993: 2003.Google Scholar
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    Williams DF. The biomaterials conundrum in tissue engineering. Tissue Eng Part A. 2014;20(7–8):1129–31.CrossRefGoogle Scholar
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    Williams DF. To engineer is to create: the link between engineering and regeneration. Trends Biotechnol. 2006;24:4–8.CrossRefGoogle Scholar
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    Williams DF. On the mechanisms of biocompatibility. Biomaterials. 2008;29(20):2941–53.CrossRefGoogle Scholar
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    Williams DF. There is no such thing as a biocompatible material. Biomaterials. 2014;35:10009–14.CrossRefGoogle Scholar
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    Williams DF. Essential Biomaterials Science. Cambridge: Cambridge University Press; 2014. p. 670.Google Scholar

Copyright information

© Springer Science+Business Media New York 2015

Authors and Affiliations

  1. 1.Wake Forest Institute of Regenerative MedicineWinston-SalemUSA

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