DANSK DSF/PREN 61010-2-101 PDF

This clause of Part 1 is applicable except as follows: 1.1.1 Equipment included in scope Replacement: Replace the text by the following: This part of 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. 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. 1.1.2 Equipment excluded from scope Addition: Add the following item: aa) Equipment in the scope of IEC 61010-2-081 unless they are specifically intended by their manufacturer to be used for in vitro diagnostic examination. 1.2 Object 1.2.1 Aspects included in scope151 Addition: Add two items: aa) biohazards; bb) hazardous chemical substances.1.2.2 Aspects excluded from scope Addition: Add the following item and note: aa) the handling or manipulation outside the equipment of material under analysis. NOTE – Requirements covering these subjects are the responsibility of committees preparing relevant standards.