• CSA C22.2 No. 60601.1.1 : 2002

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS

    Available format(s): 

    Withdrawn date:  25-08-2016

    Language(s): 

    Published date:  31-12-2010

    Publisher:  Canadian Standards Association

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

    FOREWORD
    SECTION ONE - GENERAL
    1 Scope and object
    2 Terminology and definitions
    3 General requirements
    6 Identification, marking and documents
    SECTION TWO - ENVIRONMENTAL CONDITIONS
    10 Environmental conditions
    SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
    16 ENCLOSURES and PROTECTIVE COVERS
    17 Separation
    19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
    SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
    22 Moving parts
    SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
                   EXCESSIVE RADIATION
    SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
                  FLAMMABLE ANESTHETIC MIXTURES
    SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
                    OTHER SAFETY HAZARDS
    44 Overflow, spillage, leakage, humidity, ingress of liquids,
       cleaning, sterilization, disinfection and compatibility
    49 Interruption of the power supply
    SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
                    AGAINST HAZARDOUS OUTPUT
    SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS;
                   ENVIRONMENTAL TESTS
    52 Abnormal operation and fault conditions
    SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
    56 Components and general assembly
    57 MAINS PARTS, components and layout
    58 Protective earthing - Terminals and connections
    59 Construction and layout
    Annex AAA (informative) - General guidance and rationale
    Annex BBB (informative) - Examples of combinations of MEDICAL
              ELECTRICAL EQUIPMENT and non-medical electrical
              equipment
    Annex CCC (normative) - Normative references
    Annex DDD (informative) - Bibliography
    Annex EEE (normative) - Requirements for MULTIPLE PORTABLE
              SOCKET-OUTLETS
    Annex FFF (informative) - Examples of application of MULTIPLE
              PORTABLE SOCKET-OUTLETS

    Abstract - (Show below) - (Hide below)

    Pertains to the safety of MEDICAL ELECTRICAL SYSTEMS. Describes the safety requirements necessary to provide protection for the PATIENT, the OPERATOR and surroundings.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes CSA C22.2.601.1.1. (02/2006)
    Document Type Standard
    Publisher Canadian Standards Association
    Status Withdrawn
    Superseded By
    Supersedes

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

    CSA Z17510.1 : 2010 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
    CSA C22.2 No. 60601.2.13 :2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS
    CSA Z364.2.1:2013 MONITORING SYSTEMS FOR HEMODIALYSIS EQUIPMENT
    CSA C22.2 No. 60601.2.13 : 2007 : R2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS
    CSA Z386:2014(R2019) SAFE USE OF LASERS IN HEALTH CARE
    Z364.2.1-13 (R2018) Monitoring systems for hemodialysis equipment
    CSA Z17510.2 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
    C22.2 NO. 205-17 Signal equipment
    CSA Z32 : 2015 ELECTRICAL SAFETY AND ESSENTIAL ELECTRICAL SYSTEMS IN HEALTH CARE FACILITIES

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 60950:1999 Safety of information technology equipment
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV Plugs and socket-outlets for household and similar purposes - Part1: General requirements
    ISO 8359:1996 Oxygen concentrators for medical use Safety requirements
    ISO 7767:1997 Oxygen monitors for monitoring patient breathing mixtures — Safety requirements
    IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
    ISO 9918:1993 Capnometers for use with humans Requirements
    ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction equipment
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    IEC 60989:1991 Separating transformers, autotransformers, variable transformersand reactors.
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
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