Preclinical evaluation of medical devices.
Biological evaluation should be performed as part of risk assessment of the device. It can help define the toxicity and compatibility of the device. This article outlines which tests should be performed, with some examples of specific device test regimes.
Bollen
L S
LS
Scantox A/S, Lille Skensved, Denmark. info@scantox.dk
D000818:Animals; D001672:Biocompatible Materials; D004864:Equipment and Supplies / Q000592:standards*; D005069:Evaluation Studies as Topic; D051379:Mice; D018675:Toxicity Tests
D001672:Biocompatible Materials