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Biocompatibility
What is Biocompatibility ?
Product Release Europe is normally only working with products that falls under the biocompatibility of short-term implantable devices.
The biocompatibility of a medical device that is intentionally placed within the cardiovascular system for transient diagnostic or therapeutic purposes refers to the ability of the device to carry out its intended function within flowing blood, with minimal interaction between device and blood that adversely affects device performance, and without inducing uncontrolled activation of cellular or plasma protein cascades. Product Release Europe can often only facilitate the Cytotoxicity assay.
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Meets the Bicompatibility criteria of the following
UPS Class VI Tests
Intracutaneous Test
Implantation
Systemic Injection Test
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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.
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