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      Codes & Standards - Subscribe

      CSA C22.2 NO. 60601-1-2:16 (R2021)

      Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests (IEC 60601-1-2:2014, fourth edition, 2014-02, with Canadian deviations) | Appareils électromédicaux — Partie 1-2 : Exigences générales pour la sécurité de base et les performances essentielles — Norme collatérale : Perturbations électromagnétiques — Exigences et essais (norme IEC 60601-1-2:2014 adoptée, quatrième édition, 2014-02, avec exigences propres au Canada)
      SKU: 2701963 Published by CSA Group Publication Year 2016 Reaffirmed in 2021

      Product Details

      • Preface/Scope
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      CSA Preface


      This is the fourth edition of CAN/CSA-C22.2 No. 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-2 (fourth edition, 2014-02). It supersedes the previous edition, published in 2008 as CAN/CSA-C22.2 No. 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests (adopted IEC 60601-1-2:2007). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.


      For brevity, this Standard will be referred to as “CAN/CSA-C22.2 No. 60601-1-2” throughout.


      This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, including Amendment 1:2012, 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 CSA 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 Application of Electricity in Health Care, under the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology & Systems.


      This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.


      Scope and object


      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.


      This collateral standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS in the presence of ELECTROMAGNETIC DISTURBANCES and to ELECTROMAGNETIC DISTURBANCES emitted by ME EQUIPMENT and ME SYSTEMS.


      BASIC SAFETY with regard to ELECTROMAGNETIC DISTURBANCES is applicable to all ME EQUIPMENT and ME SYSTEMS.


      1.2 Object


      The object of this collateral standard is to specify general requirements and tests for BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES and for ELECTROMAGNETIC EMISSIONS of ME EQUIPMENT and ME SYSTEMS. They are in addition to the requirements of the general standard and serve as the basis for particular standards.


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


      Préface CSA


      Ce document constitue la quatrième édition de la CAN/CSA-C22.2 nº 60601-1-2, Appareils électromédicaux — Partie 1-2 : Exigences générales pour la sécurité de base et les performances essentielles — Norme collatérale : Perturbations électromagnétiques — Exigences et essais. Il s’agit de l’adoption, avec exigences propres au Canada, de la norme IEC (Commission Électrotechnique Internationale) 60601-1-2 (quatrième édition, 2014-02) qui porte le même titre. Cette norme remplace l’édition antérieure publiée en 2008 qui portait la désignation CAN/CSA-C22.2 nº 60601-1-2, Appareils électromédicaux — Partie 1-2 : Exigences générales pour la sécurité de base et les performances essentielles — Norme collatérale: Compatibilité électromagnétique — Exigences et essais (norme IEC 60601-1-2:2007 adoptée). Elle fait partie d’une série de normes publiées par le Groupe CSA qui constituent le Code canadien de l’électricité, Deuxième partie.


      Par souci de brièveté, tout au long de ce document, il sera appelé «CAN/CSA-C22.2 nº 60601-1-2».


      Cette norme est conçu pour être utilisée de concert avec la CAN/CSA-C22.2 nº 60601-1:14, Appareils électromédicaux — Partie 1 : Exigences générales pour la sécurité de base et les performances essentielles (norme IEC 60601-1:2005 adoptée, avec exigences propres au Canada, y compris l’amendement 1:2012).


      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 au Canada par le Comité technique CSA sur les produits grand public et commerciaux, sous l’autorité du Comité directeur stratégique CSA sur les exigences en matière de sécurité électricité, et a été officiellement approuvée par le Comité technique. En raison de son contenu médical, la norme a également été approuvée par le Comité technique CSA sur les installations électriques dans les établissements de santé, sous l’autorité du Comité directeur stratégique CSA sur la technologie et les systèmes de soins de santé.


      Cette norme a été élaborée conformément aux exigences du Conseil canadien des normes concernant les Normes nationales du Canada. Cette norme a été publiée en tant que Norme nationale du Canada par Groupe CSA.


      Domaine d'application et objet


      1.1 * Domaine d’application


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


      La présente norme collatérale s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS EM et SYSTEMES EM en présence de PERTURBATIONS ELECTROMAGNETIQUES, ainsi qu’aux PERTURBATIONS ELECTROMAGNETIQUES émises par les APPAREILS EM et SYSTEMES EM.


      La SECURITE DE BASE concernant les PERTURBATIONS ELECTROMAGNETIQUES est applicable à tous les APPAREILS EM et SYSTEMES EM.


      1.2 Objet


      La présente norme collatérale a pour objet de spécifier des exigences générales et des essais applicables à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES eu égard aux PERTURBATIONS ELECTROMAGNETIQUES et pour les EMISSIONS ELECTROMAGNETIQUES des APPAREILS EM et des SYSTEMES EM. Ils viennent en complément des exigences de la norme générale et servent de base pour les normes particulières.

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      CSA C22.2 NO. 60601-1-2:16/A1:22

      Amendment 1:2022 to CSA C22.2 NO. 60601-1-2:16, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests (Adopted amendment 1:2020 to IEC 60601-1-2:2014) | Modification 1:2022 à CSA C22.2 NO. 60601-1-2:16, Appareils électromédicaux — Partie 1-2 : Exigences générales pour la sécurité de base et les performances essentielles — Norme collatérale : Perturbations électromagnétiques — Exigences et essais (amendement 1:2020 adoptée à la norme IEC 60601-1-2:2014)

      Active
      Bilingual

      CSA C22.2 NO. 60601-1-2:16 (R2021)

      Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests (IEC 60601-1-2:2014, fourth edition, 2014-02, with Canadian deviations) | Appareils électromédicaux — Partie 1-2 : Exigences générales pour la sécurité de base et les performances essentielles — Norme collatérale : Perturbations électromagnétiques — Exigences et essais (norme IEC 60601-1-2:2014 adoptée, quatrième édition, 2014-02, avec exigences propres au Canada)

      Active
      Bilingual

      CAN/CSA-C22.2 NO. 60601-1-2-08 (R2014)

      Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Adopted IEC 60601-1-2:2007, third edition, 2007-03) | Appareils électromédicaux - Partie 1-2: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Compatibilité électromagnétique - Exigences et essais (norme IEC 60601-1-2:2007 adoptée, troisième édition, 2007-03)

      Withdrawn
      Bilingual

      CAN/CSA-C22.2 NO. 60601-1-2A-03

      Amendment 1:2006 to CAN/CSA-C22.2 NO. 60601-1-2-03, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (Adopted Amendment 1:2004 to IEC 60601-1-2:2001)

      Withdrawn
      English

      CAN/CSA-C22.2 NO. 60601-1-2-03 (R08)

      Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (Adopted IEC 60601-1-2:2001, second edition, 2001-09)

      Withdrawn
      English

      CAN/CSA-C22.2 NO. 60601-1-2-03 (R08)

      Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (Adopted CEI/IEC 60601-1-2:2001 + A1:2004, edition 2.1, 2004-11) | Appareils électromédicaux - Partie 1-2: Règles générales de sécurité - Norme collatérale: Compatibilité électromagnétique - Exigences et essais (norme CEI/IEC 60601-1-2:2001 adoptée + A1:2004, édition 2.1, 2004-11)

      Withdrawn
      Bilingual

      CAN/CSA-C22.2 NO. 601.1.2-94 (R1999)

      Medical Electrical Equipment - Part 1: General Requirements for Safety - 2. Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (Adopted IEC 601-1-2:1993 with modifications) / Appareils électromédicaux - Première partie: Règles générales de sécurité - 2. Norme Collatérale: Compatibilité électromagnétique - Prescriptions et essais (norme CEI 601-1-2:1993 adoptée avec modifications)

      Withdrawn
      Bilingual
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