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      Codes & Standards - Subscribe

      CAN/CSA-C22.2 NO. 60601-1-8:08 (R2023)

      Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adopted IEC 60601-1-8:2006, second edition, 2006-10) | Appareils électromédicaux - Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences générales, essais et guide pour les systèmes d'alarme des appareils et des systèmes électromédicaux (norme IEC 60601-1-8:2006 adoptée, deuxième édition, 2006-10)
      SKU: 2702326 Published by CSA Group Publication Year 2008 Reaffirmed in 2023

      Product Details

      • Preface/Scope
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      CSA Preface


      This is the second edition of CAN/CSA-C22.2 No. 60601-1-8, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-8 (second edition, 2006-10). It supersedes the previous edition published in 2005 as CAN/CSA-C22.2 No. 60601-1-8, Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (adopted IEC 60601-1-8:2005). It is one in a series of Standards issued by CSA und


      This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:08, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted CEI/IEC 60601-1:2005, with Canadian deviations).


      This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard.


      This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the Strategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the CSA Technical Committee on Applications of Electricity in Health Care under the jurisdiction of the Strategic Steering Committee on Health Care Technology. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.er Part II of the Canadian Electrical Code.


      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.


      This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS.


      It also provides guidance for the application of ALARM SYSTEMS.


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


      Préface CSA


      Ce document constitue la deuxième édition de la CAN/CSA-C22.2 nº 60601-1-8, Appareils électromédicaux - Partie 1-8 : Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : Exigences générales, essais et guide pour les systèmes d'alarme des appareils et des systèmes électromédicaux. Il s'agit de l'adoption, sans modifications, de la norme CEI (Commission Électrotechnique Internationale) 60601-1-8 (deuxième édition, 2006-10), qui porte le même titre. Cette norme remplace l'édition précédente publiée en 2005 et intitulée CAN/CSA-C22.2 nº 60601-1-8, Appareils électromédicaux - Partie 1-8 : Règles générales de sécurité - Norme collatérale : Règles générales, essais et recommendations pour les systèmes d'alarme des appareils et des systèmes électromédicaux (norme CEI 60601-1-8:2005 adoptée). Cette norme fait partie d'une série de normes publiées par CSA lesquelles constituent le Code canadien de l'électricité, Deuxième partie.


      Cette norme est conçue pour être utilisée de concert avec la norme CAN/CSA-C22.2 nº 60601-1:08, Appareils électromédicaux — Partie 1 : Exigences générales pour la sécurité de base et les performances essentielles (norme CEI/IEC 60601-1:2005 adoptée, avec exigences propres au Canada).


      Cette norme est jugée convenable à l’évaluation de la conformité selon le domaine d’application établi dans la norme.


      Cette norme a été révisée en vue de son adoption pour le Canada par le Comité technique CSA sur les produits commerciaux et grand public, sous l’autorité du Comité directeur stratégique sur les exigences en matière de sécurité électricité, et a été officiellement approuvée par le Comité technique. Parce que cette norme touche à des concepts médicaux, elle a aussi été approuvée par le Comité technique CSA sur les installations électriques dans les établissements de santé, sous l’autorité du Comité directeur stratégique sur la technologie des soins de santé. Cette norme a été approuvée en tant que Norme nationale du Canada par le Conseil canadien des normes.


      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.


      La présente norme collatérale spécifie les exigences applicables aux SYSTÈMES D'ALARME et aux SIGNAUX D'ALARME des APPAREILS ET DES SYSTÈMES EM.


      Elle donne également des lignes directrices pour l'application des SYSTÈMES D'ALARME.

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      CAN/CSA-C22.2 NO. 60601-1-8:08 + A1:14 + A2:21 (R2023) (CONSOLIDATED)

      Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adopted IEC 60601-1-8:2006, edition 2:2006 consolidated with amendment 1:2012 and amendment 2:2020, with Canadian deviations) | Appareils électromédicaux — Partie 1-8 : Exigences générales pour la sécurité de base et les performances essentielles — Norme collatérale : Exigences générales, essais et guide pour les systèmes d’alarme des appareils et des systèmes électromédicaux (norme IEC 60601-1-8:2006 adoptée, édition 2:2006 consolidée par l’amendement 1:2012 et l’amendement 2:2020, avec exigences propres au Canada)

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      Bilingual

      CAN/CSA-C22.2 NO. 60601-1-8:08/A2:21 (R2023)

      Amendment 2:2021 to CAN/CSA-C22.2 NO. 60601-1-8:08, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adopted amendment 2:2020 to IEC 60601-1-8:2006)

      Active
      English

      CAN/CSA-C22.2 NO. 60601-1-8:F08/A2:21 (C2023)

      Modification 2:2021 à CAN/CSA-C22.2 NO. 60601-1-8:08, Appareils électromédicaux - Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences générales, essais et guide pour les systèmes d'alarme des appareils et des systèmes électromédicaux (amendement 2:2020 adoptée à la norme IEC 60601-1-8:2006)

      Active
      French

      CAN/CSA-C22.2 NO. 60601-1-8:08/A1:14 (R2023)

      Amendment 1:2014 to CAN/CSA-C22.2 NO. 60601-1-8:08, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adopted amendment 1:2012 to IEC 60601-1-8:2006) | Modification 1:2014 à CAN/CSA-C22.2 NO. 60601-1-8:08, Appareils électromédicaux - Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences générales, essais et guide pour les systèmes d'alarme des appareils et des systèmes électromédicaux (amendement 1:2014 adoptée à la norme IEC 60601-1-8:2006)

      Active
      Bilingual

      CAN/CSA-C22.2 NO. 60601-1-8:08 (R2023)

      Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adopted IEC 60601-1-8:2006, second edition, 2006-10) | Appareils électromédicaux - Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences générales, essais et guide pour les systèmes d'alarme des appareils et des systèmes électromédicaux (norme IEC 60601-1-8:2006 adoptée, deuxième édition, 2006-10)

      Active
      Bilingual

      CAN/CSA-C22.2 NO. 60601-1-8-05

      Medical Electrical Equipment - Part 1-8: General Requirements for Safety - Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems (Adopted CEI/IEC 60601-1-8:2005, first edition, 2003-08) | Appareils électromédicaux - Partie 1-8: Règles générales de sécurité - Norme collatérale: Règles générales, essais et recommandations pour les systèmes d'alarme des appareils et des systèmes électromédicaux (norme CEI/IEC 60601-1-8:2005 adoptée, première édition, 2003-08)

      Withdrawn
      Bilingual
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