BS EN 61010-2-101:2017 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, considerations have to be given to those other part 2 standards.


Cross References:
ISO 13857
ISO 14971
ISO 18113-5
EN ISO 13857
EN ISO 14971
EN ISO 18113-5
98/79/EC
EN 980:2008
ISO 15223-1
ASTM D4169


All current amendments available at time of purchase are included with the purchase of this document.