Over deze norm
IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. IVD medical equipment, whether used alone or in combination, is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning one or more of the following: - a physiological or pathological state; or - a congenital abnormality; - the determination of safety and compatibility with potential recipients; - the monitoring of therapeutic measures. Self-test IVD medical equipment is intended by the manufacturer for use by lay persons in a home environment. - THIS REDLINE VERSION PROVIDES YOU WITH QUICK AND EASY WAY TO COMPARE ALL THE CHANGES BETWEEN THIS STANDARD AND ITS PREVIOUS EDITION. A VERTICAL BAR APPEARS IN THE MARGIN WHEREVER A CHANGE HAS BEEN MADE. ADDITIONS AND DELETIONS ARE DISPLAYED IN RED, WITH DELETIONS BEING STRUCK THROUGH.
|Engelse titel||Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment (Redline version with track changes)|