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    • CAN/CSA-C22.2 NO. 60601-1:14 (R2018)

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    CAN/CSA-C22.2 NO. 60601-1:14 (R2018)

    Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Adopted IEC 60601-1:2005, third edition, 2005-12, including amendment 1:2012, 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, y compris l'amendment 1:2012, avec exigences propres au Canada)
    SKU: 2700064 Published by CSA Group Publication Year 2014 Reaffirmed in 2018

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    CSA Preface


    This is the third 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), including Amendment 1:2012. It supersedes the previous edition, published in 2008 as CAN/CSA-C22.2 No. 60601-1 (adopted IEC 60601-1:2005). For brevity, this Standard will be referred to as CAN/CSA-C22.2 No. 60601-1 throughout. 


    Scope


    1.1 * 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). 


    1.2 Object 


    The object of this standard is to specify general requirements and to serve as the basis for particular standards. 


    1.3 * Collateral standards 


    In the IEC 60601 series, collateral standards specify general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE applicable to: 


    • a subgroup of ME EQUIPMENT (e.g. radiological equipment)


    • a specific characteristic of all ME EQUIPMENT not fully addressed in this standard


    Applicable collateral standards become normative at the date of their publication and shall apply together with this standard. 


    Note 1: When evaluating compliance with IEC 60601-1, it is permissible to independently assess compliance with the collateral standards. 


    Note 2: When declaring compliance with IEC 60601-1, the declarer should specifically list the collateral standards that have been applied. This allows the reader of the declaration to understand which collateral standards were part of the evaluation. 


    Note 3: Members of IEC maintain a register of valid International Standards. Users of this standard should consult this register to determine which collateral standards have been published. 


    If a collateral standard applies to ME EQUIPMENT for which a particular standard exists, then the particular standard takes priority over the collateral standard. 


    1.4 * Particular standards 


    In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in this standard as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. 


    Note: Members of IEC and ISO maintain registers of valid International Standards. Users of this standard should consult these registers to determine which particular standards have been published. 


    A requirement of a particular standard takes priority over this standard. 


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


    Préface CSA


    Ce document constitue la troisième 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 l'amendement 1:2012, qui porte le même titre. Cette norme remplace l'édition antérieure publiée en 2008 qui portait la désignation CAN/CSA-C22.2 nº 60601-1 (norme CEI 60601-1:2005 adoptée). Par souci de brièveté, tout au long de ce document, il sera appelé «CAN/CSA-C22.2 nº60601-1». 


    Domaine d'application


    1.1 * Domaine d'application 


    La presente Norme internationale s'applique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS ELECTROMEDICAUX et des SYSTEMES ELECTROMEDICAUX, designes ci-apres sous le terme APPAREILS EM et SYSTEMES EM. 


    Si un article ou un paragraphe est specifiquement destine a etre applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES 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 a la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. 


    Les DANGERS inherents a la fonction physiologique prevue de L'APPAREIL EM ou des SYSTEMES EM dans le cadre du domaine d'application de la presente norme ne sont pas couverts par des exigences specifiques contenues dans la presente norme, a l'exception de 7.2.13 et 8.4.1. 


    Note: Voir aussi 4.2. 


    La presente norme peut egalement etre appliquee aux appareils utilises pour l'attenuation d'une maladie, la compensation ou l'attenuation d'une blessure ou d'une incapacite. 


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


    1.2 Objet 


    La presente Norme est destinee a specifier des exigences generales et a servir de base pour les normes particulieres. 


    1.3 * Normes collatérales 


    Dans la serie CEI 60601, les normes collaterales specifient des exigences generales pour la SECURITE DE BASE et pour les PERFORMANCES ESSENTIELLES applicables a: 


    • un sous-groupe d'APPAREILS EM (par exemple appareils de radiologie) 


    • une caracteristique specifique a tous les APPAREILS EM qui n'est pas completement traitee dans la presente norme 


    Les normes collaterales applicables prennent une valeur normative a la date de leur publication et elles doivent s'appliquer avec la presente norme. 


    Note 1: Lors de l'evaluation de la conformite a la CEI 60601-1, il est admissible d'evaluer de maniere independante la conformite aux normes collaterales. 


    Note 2: Lorsqu'il declare qu'un appareil est conforme a la CEI 60601-1, il convient que le declarant donne specifiquement la liste des normes collaterales qui ont ete appliquees. Cela permet a toute personne lisant la declaration de connaitre quelles normes collaterales ont fait partie de l'evaluation. 


    Note 3: Les membres de la CEI tiennent a jour le registre des Normes internationales en vigueur. Il convient que les utilisateurs de la presente norme consultent ce registre pour determiner quelles normes collaterales ont ete publiees. 


    Si une norme collaterale s'applique a des APPAREILS EM pour lesquels il existe une norme particuliere, cette norme particuliere prevaut sur la norme collaterale. 


    1.4 * Normes particulières 


    Dans la serie CEI 60601, des normes particulieres peuvent modifier, remplacer ou supprimer des exigences contenues dans la presente norme en fonction de ce qui est approprie a l'APPAREIL EM considere et elles peuvent ajouter d'autres exigences de SECURITE DE BASE et de PERFORMANCES ESSENTIELLES. 


    Note: Les membres de la CEI et de l'ISO possedent le registre des Normes internationales en vigueur. Il convient que les utilisateurs de la presente norme consultent ces registres pour determiner quelles normes specifiques ont ete publiees. 


    Une exigence d'une norme particuliere prevaut sur l'exigence correspondante de la presente norme.

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    CAN/CSA-C22.2 NO. 60601-1:14/A2:22

    Amendment 2:2022 to CAN/CSA-C22.2 NO. 60601-1:14, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Adopted amendment 2:2020 to IEC 60601-1:2005, with Canadian deviations) | Modification 2:2022 à CAN/CSA-C22.2 NO. 60601-1:14, Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles (amendement 2:2020 adoptée à la norme CEI 60601-1:2005, avec exigences propres au Canada)

    Active
    Bilingual

    CAN/CSA-C22.2 NO. 60601-1:14 (R2018)

    Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Adopted IEC 60601-1:2005, third edition, 2005-12, including amendment 1:2012, 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, y compris l'amendment 1:2012, avec exigences propres au Canada)

    Active
    Bilingual

    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)

    Withdrawn
    Bilingual

    C22.2 NO. 601.1S1-94 (R1999)

    Supplement No. 1-94 to CAN/CSA-C22.2 No. 601.1-M90 - Medical Electrical Equipment - Part 1: General Requirements for Safety (Adopted IEC 601-1, Amendment 1:1991) / Supplément no 1-94 à la norme CAN/CSA-C22.2 no 601.1-M90 - Appareils électromédicaux - Première partie: Règles générales de sécurité (norme CEI 601-1, modification 1:1991 adoptée)

    Withdrawn
    Bilingual

    CAN/CSA-C22.2 NO. 601.1-M90 (R2005)

    Medical Electrical Equipment - Part 1: General Requirements for Safety

    Withdrawn
    English

    CAN/CSA-C22.2 NO. 601.1-FM90 (C2005)

    Appareils électromédicaux - Première partie: Règles générales de sécurité

    Withdrawn
    French
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