IEC 60601-1-12-ed.1.0

Podrobné informace

Označení: IEC 60601-1-12-ed.1.0

Datum vydání: 19.06.2014

Stran: 101

Země: Mezinárodní technická norma

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Anotace

IEC 60601-1-12:2014 constitutes a collateral standard to IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. Medical practice is increasingly using medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the emergency medical services environment. The safety of medical electrical equipment in this uncontrolled, rough environment is a cause for concern. This collateral standard was developed with contributions from clinicians, engineers and regulators. The terminology, requirements, general recommendations and guidance of this collateral standard are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and for technical committees responsible for the development of particular standards. This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, which are intended, as indicated in the instructions for use by their manufacturer, for use in the EMS environment (Emergency Medical Services environment). The object of this collateral standard is to provide general requirements for ME equipment and ME systems carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. LIEC 60601-1-12:2014 constitue une norme collaterale de lIEC 60601-1: Appareils electromedicaux - Partie 1: Exigences generales pour la securite de base et les performances essentielles designee ci-apres par norme generale. La pratique medicale utilise de plus en plus des appareils electromedicaux et des systemes electromedicaux pour la surveillance, le traitement ou le diagnostic des patients dans lenvironnement des services medicaux durgence. La securite des appareils electromedicaux dans cet environnement particulierement difficile et non controle, est source de preoccupation. La presente norme collaterale a ete elaboree grace aux contributions de medecins cliniciens, dingenieurs et dautorites de tutelle. La terminologie, les exigences, les recommandations generales et les lignes directrices contenues dans la presente norme collaterale ont pour objectif detre utiles aux fabricants dappareils electromedicaux et de systemes electromedicaux et aux comites techniques responsables de lelaboration des normes particulieres. La presente Norme internationale sapplique a la securite de base et aux performances essentielles des appareils electromedicaux et des systemes electromedicaux, designes ci-apres par appareils EM et systemes EM, destines, comme indique dans les instructions dutilisation, par leur fabricant a etre utilises dans lenvironnement SMU (environnement des Services Medicaux dUrgence). Lobjet de la presente norme collaterale est de fournir des exigences generales pour les appareils EM et les systemes EM achemines et utilises sur les lieux dune intervention en urgence, ainsi que pour leur transport, dans des situations ou les conditions ambiantes sont differentes des conditions interieures. La presente norme collaterale est destinee a specifier des exigences generales qui viennent sajouter a celles de la norme generale et a servir de base pour les normes particulieres.