• CSA C22.2 No. 60601.1 : 2014

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE

    Available format(s):  Hardcopy, PDF

    Superseded date:  28-01-2022

    Language(s):  English

    Published date:  01-01-2014

    Publisher:  Canadian Standards Association

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    Table of Contents - (Show below) - (Hide below)

    FOREWORD
    INTRODUCTION
    1 Scope, object and related standards
    2 Normative references
    3 Terminology and definitions
    4 General requirements
    5 General requirements for testing ME EQUIPMENT
    6 Classification of ME EQUIPMENT and ME SYSTEMS
    7 ME EQUIPMENT identification, marking and documents
    8 Protection against electrical HAZARDS from ME EQUIPMENT
    9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
       ME SYSTEMS
    10 Protection against unwanted and excessive radiation HAZARDS
    11 Protection against excessive temperatures and other HAZARDS
    12 Accuracy of controls and instruments and protection against
       hazardous outputs
    13 HAZARDOUS SITUATIONS and fault conditions
    14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
    15 Construction of ME EQUIPMENT
    16 ME SYSTEMS
    17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
    Annex A (informative) - General guidance and rationale
    Annex B (informative) - Sequence of testing
    Annex C (informative) - Guide to marking and labelling
            requirements for ME EQUIPMENT and ME SYSTEMS
    Annex D (informative) - Symbols on marking
    Annex E (informative) - Examples of the connection of the
            measuring device (MD) for measurement of the
            PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT
    Annex F (informative) - Suitable measuring supply circuits
    Annex G (normative) - Protection against HAZARDS of ignition
            of flammable anaesthetic mixtures
    Annex H (informative) - PEMS structure, PEMS DEVELOPMENT
            LIFE-CYCLE and documentation
    Annex I (informative) - ME SYSTEMS aspects
    Annex J (informative) - Survey of insulation paths
    Annex K (informative) - Simplified PATIENT LEAKAGE CURRENT
            diagrams
    Annex L (normative) - Insulated winding wires for use
            without interleaved insulation
    Annex M (normative) - Reduction of pollution degrees
    Bibliography
    INDEX
    INDEX OF ABBREVIATIONS AND ACRONYMS

    Abstract - (Show below) - (Hide below)

    Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS designed to be used in accordance with CSA C22.1 (Canadian Electrical Code, Part I) and CSA Z32.

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    Development Note Supersedes CSA C22.2.601.1. (03/2008)
    Document Type Standard
    Publisher Canadian Standards Association
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    CSA Z10524-3 : 2012 : INC : AMD 1 : 2017 : R201700 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
    CSA Z8835.3 : 2008 INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
    CSA Z23747 : 2008 : R2013 ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
    CSA Z10535.1 : 2015 HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
    CSA C22.2 No. 60601-2-6 : 2014 : R2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-6: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MICROWAVE THERAPY EQUIPMENT
    CSA Z10651-5 : 2008 : R2013 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
    CAN/CSA-C22.2 NO. 80601-2-72:17 Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations)
    CSA Z8185 : 2008(R2013) RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    CSA Z8185 : 2008 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    C22.2 NO. 269.3-17 Surge protective devices - Type 3 - Cord connected, direct plug-in and receptacle type
    CSA Z902 : 2010 : R2015 BLOOD AND BLOOD COMPONENTS
    CSA Z17510.1 : 2010 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
    CSA Z10651-5 : 2008 : INC : UPD 1 : 2011 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
    Z364.6-17 Quality management for kidney dialysis providers
    CSA C22.2 No. 60601.1.2 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
    CSA C22.2 No. 60601.2.26 : 2014(R2018) MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIS SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS
    CSA C22.2 No. 60601-2-19 : 2009 : R2014 MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS
    CSA C22.2 No. 62368-1 : 2014 AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS
    CSA Z10524-3 : 2012 : R2017 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
    CSA C22.2 No. 60065 : 2016 AUDIO, VIDEO AND SIMILAR ELECTRONIC APPARATUS - SAFETY REQUIREMENTS
    CSA SPE 3000 : 2015 MODEL CODE FOR THE FIELD EVALUATION OF MEDICAL ELECTRICAL EQUIPMENT AND SYSTEMS
    CSA C22.2 No. 60601-2-21 : 2010FR MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS
    CSA C22.2 No. 60601-1-12 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT
    CSA C22.2 No. 60601.2.47 : 2014(R2018) MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS
    CSA Z17510.2 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
    CSA C22.2 No. 80601-2-12 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
    CSA C22.2 No. 60601-2-21 : 2010 : INC : COR 1 : 2017 : R201400 MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS
    CSA C22.2 No. 60601-1-11 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT
    CSA Z18779 : 2008 : R2013 MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
    CSA Z364.2.1:2013 MONITORING SYSTEMS FOR HEMODIALYSIS EQUIPMENT
    CAN/CSA-Z7376:12 (R2017) Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (Adopted ISO 7376:2009, second edition, 2009-08-15, with Canadian deviations)
    CSA C22.2 No. 60601-2-6 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 2-6: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MICROWAVE THERAPY EQUIPMENT
    CSA C22.2 No. 60601-2-3 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 2-3: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SHORT-WAVE THERAPY EQUIPMENT
    CSA Z8835.2 : 2008 INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS FOR ADULTS
    CSA C22.2 No. 80601-2-12 : 2012(R2017) MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
    CSA Z10524-3 : 2012 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
    CSA Z23747:2008 ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
    CSA C22.2 No. 269 PACKAGE : 2017 CONSISTS OF C22.2 NO. 269.1-17 - SURGE PROTECTIVE DEVICES - TYPE 1 - PERMANENTLY CONNECTED; C22.2 NO. 269.2-17 - SURGE PROTECTIVE DEVICES - TYPE 2 - PERMANENTLY CONNECTED; C22.2 NO. 269.3-17 - SURGE PROTECTIVE DEVICES - TYPE 3 - CORD CONNECTED, DIRECT PLUG-IN AND RECEPTACLE TYPE; C22.2 NO. 269.4-17 - SURGE PROTECTIVE DEVICES - TYPE 4 - COMPONENT ASSEMBLIES AND C22.2 NO. 269.5-17 - SURGE
    CSA Z10651-5 : 2008 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
    CSA Z902 : 2010 : INC : UPD 1 : 2012 BLOOD AND BLOOD COMPONENTS
    CSA Z7376 : 2012 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
    CSA Z32 : 2015 ELECTRICAL SAFETY AND ESSENTIAL ELECTRICAL SYSTEMS IN HEALTH CARE FACILITIES
    CSA Z10651-5 : 2008 : R2018 Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-Powered Emergency Resuscitators
    CSA C22.2 No. 60601-2-21 : 2010 : R2014 MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS
    CSA Z902 : 2010 : INC : UPD 2 : 2012 BLOOD AND BLOOD COMPONENTS
    CSA Z902 : 2010 : INC : UPD 1 : 2012 : FR BLOOD AND BLOOD COMPONENTS
    CSA C22.2 No. 60601-2-19 : 2009 : INC : COR 1 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS
    CSA C22.2 No. 80601-2-69 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT
    CAN/CSA-C22.2 NO. 80601-2-67:17 Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen conserving equipment (Adopted ISO 80601-2-67:2014, first edition, 2014-06-01, with Canadian deviations)
    CAN/CSA-C22.2 NO. 80601-2-71:17 Medical electrical equipment — Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment (Adopted IEC 80601-2-71:2015, first edition, 2015-06, with Canadian deviations)
    Z10535.2-17 Lifts for the transfer of persons - Installation, use, and maintenance
    CAN/CSA-C22.2 NO. 60601-2-19-09 (R2018) Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (Adopted IEC 60601-2-19:2009, second edition, 2009-02) | Appareils électromédicaux - Partie 2-19: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs pour nouveau- nés (norme CEI 60601-2-19:2009 adoptée, deuxième édition, 2009-02)
    CAN/CSA-C22.2 NO. 80601-2-70:17 Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition, 2015-01 , with Canadian deviations)
    Z364.2.1-13 (R2018) Monitoring systems for hemodialysis equipment
    CSA Z18779 : 2008 MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
    CSA C22.2 No. 60601.2.16 : 2014(R2019) MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
    CSA Z902 : 2010 BLOOD AND BLOOD COMPONENTS
    CSA Z305.13 : 2013(R2018) PLUME SCAVENGING IN SURGICAL, DIAGNOSTIC, THERAPEUTIC, AND AESTHETIC SETTINGS
    CSA C22.2 No. 60601.2.40 : 2017 MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT
    CSA C22.2 No. 60601-2-21 : 2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS

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    IEC TS 60479-1:2005+AMD1:2016 CSV Effects of current on human beings and livestock - Part 1: Generalaspects
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