Good day all,
I have a little problem here. It appears that one of our device indicated activation of complement after 90 mins.
Although this test is not part of ISO10993-4 requirments for this particular device, BSI requested for justifications to support the biocompatibility of the device. I appreciate if you could share your experience/ ideas.
Here are the concentration of sc5b-9 after 30, 60, 90 mins of incubation of the test article and predicate..
Regards,
Judy
I have a little problem here. It appears that one of our device indicated activation of complement after 90 mins.

Although this test is not part of ISO10993-4 requirments for this particular device, BSI requested for justifications to support the biocompatibility of the device. I appreciate if you could share your experience/ ideas.
Here are the concentration of sc5b-9 after 30, 60, 90 mins of incubation of the test article and predicate..

Regards,
Judy