Biocompatibility Reports

Polymerized Dymax MD® Medical Device adhesives are biocompatibility tested in accordance with ISO 10993 and/or USP Class VI. The completed tests are listed on each product data sheet. In all cases, it is the user’s responsibility to determine and validate the suitability of these adhesives in the intended medical device. These adhesives have not been tested for prolonged or permanent implantation, and are only intended for use in short-term (<29 days) or single use disposable device applications. Dymax does not authorize their use in long term implant applications.

»   Copies of the test reports are available upon request.

Typical Tests Include:
  • ISO 10993-4 Hemolysis
  • ISO 10993-5 Cytotoxicity
  • ISO 10993-6 Implantation 14 Days
  • ISO 10993-10 Intracutaneous
  • ISO 10993-11 Systemic Toxicity