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


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.


Tissue Engineering Medical Device International Standard Organization Implantable Device Biological Safety 
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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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