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Our coatings meets the bicompatibility criteria of the following
UPS Class VI Tests
Intracutaneous Test
Implantation
Systemic Injection Test
Other Tests
Cytotoxicity Assay
Hemolysis
Ames Mutagenicity Test
USP Rabbit Pyrogen Test
USP Safety Test
Sensitization Test
Whole Blood Coagulation Test
These results were obtained
using representative substrate
materials such as polyvinylchloride
polyolefin, polyamide,
polyurethane and stainless
steel. Manufacturers would need
to conduct appropriate testing on
each of their combinations
of substrate and coating.
Product Release Europe don't test for biocompatability because the regulatory agencies always want the tests to be conducted with the coating on the device. All of our coatings currently in use have been tested by our clients with their devices and to our knowledge none have found unacceptable biocompatability test results.
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