scope:

This clause of part 1 is applicable except as follows: 1.1.1 Equipment included in scope Replacement: 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. 1.1.2 Equipment excluded from scope Addition: Add the following paragraph: aa) Products for general laboratory use as defined in the scope of IEC 61010-2-081 unless they are specifically intended by their manufacturer to be used for in vitro diagnostic examination.