Biocompatibility Reports

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 Datasheet (PDS).

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 the use in long-term implant applications.

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

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