 Nadine Blaesing Dymax Corp. Market Segment Manager Visit Website |
Nadine Blaesing is the market segment manager, Europe, for Dymax. She has more than 12 years of experience selling adhesives and providing technical assistance to the medical device market. Although she began her career as an applications engineer in Europe, and later in the United States, Blaesing eventually transitioned into marketing while keeping her focus on the medical device industry. Dymax specializes in the manufacture of light-curable adhesives, cyanoacrylates, epoxies, light-emitting curing equipment, and dispensing systems.
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Adhesives and Epoxies Q&A
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Do you have FDA-approved structural and nonstructural adhesives for artificial hearts? Which standard applies or is more relevant: ISO 10993, USP Class VI, or another standard?Answered April 4th, 2011 by Expert: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 short-term use (<29 days) or single-use disposable device applications. We do not authorize their use in long-term implant applications.
Polymerized MD medical device adhesives are biocompatibility tested in accordance with ISO 10993 and/or USP Class VI standards. ISO 10993 is a newer, internationally accepted standard. The current Dymax test protocol for medical adhesives is based on the following standards:
- ISO 10993-4: hemolysis
- ISO 10993-5: cytotoxicity
- ISO 10993-6: implantation for 14 days
- ISO 10993-10: intracutaneous use
- ISO 10993-11: systemic toxicity
Older Dymax adhesives have been tested in accordance with USP Class VI, which covers systemic toxicity, intracutaneous, and a seven-day implantation test. When comparing both standards, USP Class VI is included in and covered by ISO 10993.