New trends in biological evaluation of medical devices.
More extensive material characterisation and increased determination of toxicological risks are now required when evaluating new medical devices. The new requirements together with other changes in the ISO 10993 series described here suggest how companies can adjust their approach.
Bollen
L S
LS
SantoxA/S, LAB Research International, Lille Skensved, Denmark. bollenl@labinc.dk
D003257:Consumer Product Safety / Q000592:standards*; D018795:Device Approval / Q000592:standards*; D004864:Equipment and Supplies; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D008422:Materials Testing / Q000592:standards*; D012308:Risk Management / Q000379:methods*; D012985:Software Design; D018675:Toxicity Tests