Progress in testing.
Significant changes in the approach to determining the nonclinical compatibility of medical devices are on the way with the revision of ISO 10993, Biological Evaluation of Medical Devices, Part 4, Selection of Tests for Interactions with Blood.
Upman
P J
PJ
NAMSA, 2261 Tracy Road, Northwood, Ohio 43619, USA. pupman@namsa.com
D000818:Animals; D001672:Biocompatible Materials / Q000009:adverse effects*; D001769:Blood / Q000187:drug effects*; D019544:Equipment Failure Analysis / Q000379:methods / Q000592:standards*; D004869:Equipment Safety / Q000379:methods / Q000592:standards* / Q000639:trends; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D007391:International Cooperation; D008422:Materials Testing / Q000379:methods / Q000592:standards; D011786:Quality Control
D001672:Biocompatible Materials