IEC 61010-2-101:2018 PDF

Scope: Equipment included in scope 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 the IEC 61010 series as well as within the scope of this document@ consideration is given to those other Part 2 standards. Equipment excluded from scope equipment within the scope of IEC 61010-2-081 unless it is specifically intended by the manufacturer to be used for in vitro diagnostic examination. Object Aspects included in scope biohazards; hazardous chemical substances. Aspects excluded from scope the handling or manipulation outside the equipment of material under analysis. NOTE Requirements covering these subjects are the responsibility of committees preparing the relevant standards.

IEC 61010-2-101:2018 Referenced Document

ISO 14971:2007 Medical devices - Application of risk management to medical devices
ISO 18113-5:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing

0000 IEC 61010-2-101:2018 RLV
0000 IEC 61010-2-101:2015 RLV
2002 IEC 61010-2-101:2002 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment