Biocompatibility Testing

Proving that your material or product is biocompatible and therefore safe for implantation into, or contact with, the body is a necessity for regulatory approval - the extent of testing required depends on the intended use of the product, and we can help guide you through this process.

Without comprehensive, independent testing, the product will be unable to be introduced into the market. Lucideon provides testing to ISO 10993 (parts 5, 7, 9, 12, 13, 14, 15, 18 and 19) - an essential requirement for regulatory approval.

We offer the following biocompatibility testing:

  • Extractables/leachables testing (including extraction)
  • Chemical, physical, morphological and topographical characterization of materials
  • Identification and quantification of degradation products (polymers, metals, ceramics) including sample preparation
  • Ethylene oxide sterilization residuals testing
  • Cytotoxicity testing.

We don't just provide data - our service is backed up by analysis and support.

In addition, our team of materials experts can work with you to develop biocompatible materials and products and, should failures occur and you find that your product has issues with biocompatibility, we can help you to solve those failures quickly and effectively.

Please note that we do not conduct any in vivo animal testing.

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Resources

  • White paper

    Regulatory Approval Testing of Hydroxyapatite - The Benefits of Using One Supplier

    pdf 380 KB

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