UNE-EN IEC 61010-2-101:2023

1 Scope and objectThis clause of part 1 is applicable except as follows:1.1.1 Equipment included in scopeReplacement: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 themanufacturer to be used in vitro for the examination of specimens, including blood and tissuesamples, derived from the human body, solely or principally for the purpose of providinginformation 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 ahome environment.NOTE If all or part of the equipment falls within the scope of one or more other part 2 standards of IEC 61010 aswell 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 scopeAddition:Add the following paragraph:aa) Products for general laboratory use as defined in the scope of IEC 61010-2-081 unlessthey are specifically intended by their manufacturer to be used for in vitro diagnosticexamination.1.2 Object1.2.1 Aspects included in scopeAddition:Add two items:aa) biohazards;bb) hazardous chemical substances.1.2.2 Aspects excluded from scopeAddition: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.