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    • CAN/CSA-C22.2 NO. 60601-1-08 (R2013)

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    CAN/CSA-C22.2 NO. 60601-1-08 (R2013)

    Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (Adopted IEC 60601-1:2005, third edition, 2005-12, including corrigendum 1:2006, and with Canadian deviations) | Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles (norme CEI 60601-1:2005 adoptée, troisième édition, 2005-12, avec rectificatif 1:2006, et avec exigences propres au Canada)
    SKU: 2418733 Published by CSA Group Publication Year 2008 Reaffirmed in 2013 822 pages Withdrawn

    View Access for this document is only available for viewers in Canada

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    • Preface/Scope
    Preface

    This is the second edition of CAN/CSA-C22.2 No. 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1 (third edition, 2005-12), which incorporates Corrigendum 1:2006. It supersedes the previous edition published in 1990 as CAN/CSA-C22.2 No. 601.1, Medical Electrical Equipment - Part 1: General Requirements for Safety (adopted IEC 601-1:1988).

    Scope

    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.

    If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

    HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1. NOTE See also 4.2.

    This Standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability.

    In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series 2). This Standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1 3).

    ------------------------------------------------------------------------

    Préface 

    Ce document constitue la deuxième édition de la CAN/CSA-C22.2 nº 60601-1, Appareils électromédicaux - Partie 1 : Exigences générales pour la sécurité de base et les performances essentielles. Il s'agit de l'adoption, avec exigences propres au Canada, de la norme CEI (Commission Électrotechnique Internationale) 60601-1 (troisième édition, 2005-12), y compris les révisions du Corrigendum 1:2006, qui porte le même titre. Il remplace l'édition précédente publiée en 1990 et intitulée CAN/CSA-C22.2 nº 601.1, Appareils électromédicaux - Première partie : Règles générales de sécurité (norme CEI 601-1:1988 adoptée).

    Domaine d’application

    La présente Norme internationale s'applique à la SÉCURITÉ DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS ÉLECTROMÉDICAUX et des SYSTÈMES ÉLECTROMÉDICAUX, désignés ci-après sous le terme APPAREILS EM et SYSTÈMES EM.

    Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTÈMES EM, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux APPAREILS EM et aux SYSTÈMES EM, selon le cas.

    Les DANGERS inhérents à la fonction physiologique prévue de L'APPAREIL EM ou des SYSTÈMES EM dans le cadre du domaine d'application de la présente norme ne sont pas couverts par des exigences spécifiques contenues dans la présente norme, à l'exception de 7.2.13 et 8.4.1. NOTE Voir aussi 4.2.

    La présente norme peut également être appliquée aux appareils utilisés pour l'atténuation d'une maladie, la compensation ou l'atténuation d'une blessure ou d'une incapacité.

    Les appareils de diagnostic in vitro qui n'entrent pas dans la définition des APPAREILS EM sont couverts par la série CEI 61010 2). La présente norme ne s'applique pas aux parties implantables des dispositifs médicaux implantables actifs couverts par l'ISO 14708-1 3).
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