IEC 80601-2-49-ed.1.0

Detail information

Designation: IEC 80601-2-49-ed.1.0

Publication date: 08/03/2018

Pages: 82

Country: International technical standard

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Anotation

IEC 80601-2-49:2018 applies to basic safety and essential performance requirements of multifunction patient monitors, hereafter referred to as ME equipment or medical electrical systems. This particular standard applies to multifunction patient monitors intended for use in professional healthcare facilities as well as in the emergency medical service environment or the home healthcare environment. The scope of this document is restricted to ME equipment or medical electrical systems intended for connection to a single patient that has two or more physiological monitoring units. For purposes of this document, a pregnant mother and her fetus(es) are considered a single patient. This document does not specify requirements for individual physiological monitoring units such as ECG, invasive pressure and pulse oximetry. The particular standards related to these physiological monitoring units specify requirements from the perspective of stand-alone ME equipment. This particular standard addresses the additional requirements related to multifunction patient monitors. Multifunction patient monitors can be integrated into other ME equipment or medical electrical systems. When this is the case, other relevant standards also apply. This document does not apply to implantable parts of multifunction patient monitors. This first edition cancels and replaces the second edition of IEC 60601-2-49, published in 2011. This edition constitutes a technical revision to align with the current edition and Amendment to IEC 60601-1, new versions of collateral standards and amendments thereto. Major changes are in Clause 208 because many of the former requirements are now addressed by IEC 60601-1-8. L’IEC 80601-2-49:2018 sapplique aux exigences pour la securite de base et les performances essentielles des moniteurs multifonctions des patients, designes ci-apres par appareils EM ou systemes electromedicaux. La presente norme particuliere sapplique aux moniteurs multifonctions des patients destines a etre utilises dans les etablissements professionnels de sante ainsi que dans lenvironnement des services medicaux durgence ou dans lenvironnement des soins a domicile. Le domaine dapplication du present document est limite aux appareils EM ou aux systemes electromedicaux destines a la connexion a un patient unique qui comportent au minimum deux unites de surveillance physiologique. Le present document ne specifie pas dexigences pour les unites de surveillance physiologique individuelles telles que lECG, la pression prelevee directement et loxymetrie de pouls. Les normes particulieres relatives a ces unites de surveillance physiologique specifient des exigences dans la perspective dappareils EM autonomes. La presente norme particuliere aborde les exigences supplementaires relatives aux moniteurs multifonctions des patients. Les moniteurs multifonctions des patients peuvent etre integres dans dautres appareils EM ou systemes electromedicaux. Lorsque cest le cas, dautres normes sappliquent egalement. Le present document ne sapplique pas aux parties implantables des moniteurs multifonctions des patients. Cette premiere edition annule et remplace la deuxieme edition de lIEC 60601-2-49 parue en 2011. Cette edition constitue une revision technique et permet un alignement avec ledition actuelle de lIEC 60601-1 et son Amendement, ainsi quavec les nouvelles versions des normes collaterales et de leurs amendements. Les modifications majeures concernent lArticle 208, car une grande partie des exigences precedentes sont desormais traitees dans lIEC 60601-1-8.