IEC 60601-2-25-ed.2.0

Detail information

Designation: IEC 60601-2-25-ed.2.0

Publication date: 19/10/2011

Pages: 196

Country: International technical standard

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Anotation

IEC 60601-2-25:2011 applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes. The equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physicians office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to Medical electrical equipment for those environments of use. Not included within the scope of this particular standard are: a) the part of Medical electrical equipment that provides vectorcardiographic loops; b) ambulatory electrocardiographic medical electrical equipment covered by IEC 60601-2-47 where not intended for obtaining electrocardiogram reports for diagnostic purposes; c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining electrocardiographic reports for diagnostic purposes. This second edition cancels and replaces the first edition of IEC 60601-2-25, published in 1993 and the first edition of IEC 60601-2-51, published in 2003. Updating the particular standards to refer to the third edition of the general standard provided the opportunity to merge the first editions of IEC 60601-2-25 and IEC 60601-2-51 into one standard. Reformatting and technical changes were both made. This second edition of IEC 60601-2-25 constitutes a technical revision of both those standards. La CEI 60601-2-25:2011 sapplique a la securite de base et aux performances essentielles des electrocardiographes, destines de par leur nature ou comme partie integrante dun systeme electro-medical, a la production de rapports delectrocardiographie a des fins de diagnostic. Les appareils destines a etre utilises dans des conditions environnementales extremes ou non maitrisees a lexterieur dun hopital ou du cabinet dun medecin, telles que dans des ambulances et dans un aeronef, doivent satisfaire a la presente norme particuliere. Des normes supplementaires peuvent sappliquer pour ces environnements dutilisation. Ne relevent pas du domaine dapplication de la presente norme particuliere: a) la partie des appareils electro-medicaux qui fournit des boucles vecto-cardiographiques; b) les appareils electro-medicaux de surveillance electrocardiographique ambulatoire couverts par la CEI 60601-2-47, lorsquils ne sont pas destines a obtenir des rapports delectrocardiographie a des fins de diagnostic; c) les moniteurs cardiaques couverts par la CEI 60601-2-27 lorsquils ne sont pas destines a obtenir des rapports delectrocardiographie a des fins de diagnostic. Cette deuxieme edition annule et remplace la premiere edition de la CEI 60601-2-25, parue en 1993, et la premiere edition de la CEI 60601-2-51, parue en 2003. La mise a jour des normes particulieres afin de faire reference a la troisieme edition de la norme generale a permis de fusionner les premieres editions de la CEI 60601-2-25 et de la CEI 60601-2-51 en une seule norme. Une remise en forme et des modifications techniques ont ete effectuees. Cette deuxieme edition de la CEI 60601-2-25 constitue une revision technique de ces deux normes.