“Do you have an FDA-approved adhesive for artificial hearts (structural and non-structural adhesive)? Which standard is more relevant and which standard applies – ISO 10993, USP Class VI, or another standard?”
If you are referring to implantable artificial hearts, we have to pass. DYMAX 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.
Polymerized DYMAX MD® Medical Device adhesives are biocompatibility tested in accordance with ISO 10993 and/or USP Class VI. ISO 10993 is a newer, internationally accepted standard. The current DYMAX test protocol for medical adhesives contains the following studies:
- ISO 10993-4 Hemolysis
- ISO 10993-5 Cytotoxicity
- ISO 10993-6 Implantation 14 Days
- ISO 10993-10 Intracutaneous
- ISO 10993-11 Systemic Toxicity
Older DYMAX adhesives have been tested in accordance with USP Class VI, which consists of Systemic Toxicity, Intracutaneous and a 7-days Implantation Test. When comparing both standards, USP Class VI is included in and covered by ISO 10993.