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Regulatory biocompatibility requirements for biomaterials used in regenerative medicine

  • Special Issue: ESB 2014
  • Biocompatibility Studies
  • Published:
Journal of Materials Science: Materials in Medicine Aims and scope Submit manuscript

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.

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References

  1. International Standards Organization, biological evaluation of medical devices, part 1 evaluation and testing, ISO 10993: 2003.

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Authors and Affiliations

  1. Wake Forest Institute of Regenerative Medicine, Winston-Salem, NC, 27157, USA

    David F. Williams

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  1. David F. Williams
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Correspondence to David F. Williams.

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Williams, D.F. Regulatory biocompatibility requirements for biomaterials used in regenerative medicine. J Mater Sci: Mater Med 26, 89 (2015). https://doi.org/10.1007/s10856-015-5421-7

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  • DOI: https://doi.org/10.1007/s10856-015-5421-7

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