Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 2-101: Particular Requirements for in Vitro Diagnostic (IVD) Medical Equipment
|Publication Date:||1 January 2002|
|ICS Code (Electrical and electronic testing):||19.080|
|ICS Code (Diagnostic equipment):||11.040.55|
This part 2 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.
NOTE If all or part of the equipment falls within the scope of one or more other part 2 standards of IEC 61010 as well as within the scope of this standard, it will also need to meet the requirements of those other part 2 standards.