DIN EN 61010-2-101:2017-10

This part IEC 61010-2-101 of the IEC 61010 series of international standards 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. If the whole or part of the appliance falls within the scope of both this standard and another Part 2 or several other Parts 2 of the IEC 61010 series of standards it is necessary to consider these other Part 2 standards as well. IEC 61010-2-101 shall be applied together with the latest edition of IEC 61010 1. This part IEC 61010-2-101 has been prepared on the basis of the third edition (2010) of IEC 61010-1. This part supplements or amends the corresponding clauses of IEC 61010-1, thereby converting this standard into IEC 61010-2-101 "Safety requirements for in vitro diagnostic (IVD) medical devices". Where a particular clause or subclause of Part 1 is not mentioned in this Part, that clause or subclause shall apply where applicable. Where "addition", "amendment", "replacement" or "deletion" is indicated in this Part, the correspondingly adapted text of Part 1 of the standard shall apply. The responsible committee is DKE/K 913 "Sicherheitsanforderungen an typische Geräte, Einrichtungen und Systeme für Labor und Unterricht" ("Safety requirements for typical apparatus, equipment and systems for laboratory and teaching purposes") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.