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  • CSA C22.2 No. 80601-2-61 : 2014(R2019)

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  29-07-2021

    Language(s):  English, French

    Published date:  01-01-2014

    Publisher:  Canadian Standards Association

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

    Foreword
    Introduction
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing of ME EQUIPMENT
    201.6 Classification of ME EQUIPMENT and ME SYSTEMS
    201.7 ME EQUIPMENT identification, marking and documents
    201.8 Protection against electrical HAZARDS from ME EQUIPMENT
    201.9 Protection against mechanical HAZARDS of ME EQUIPMENT
            and ME SYSTEMS
    201.10 Protection against unwanted and excessive radiation
            HAZARDS
    201.11 Protection against excessive temperatures and other
            HAZARDS
    201.12 ACCURACY of controls and instruments and protection
            against hazardous outputs
    201.13 HAZARDOUS SITUATIONS and fault conditions
    201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 ME SYSTEMS
    201.17 Electromagnetic compatibility of ME EQUIPMENT and ME
            SYSTEMS
    201.101 PULSE OXIMETER PROBES and PROBE CABLE EXTENDERS
    201.102 Saturation pulse INFORMATION SIGNAL
    201.103 SIGNAL INPUT/OUTPUT PART
    202 Medical electrical equipment - Part 1-2: General
            requirements for safety - Collateral standard:
            Electromagnetic compatibility - Requirements
            and tests
    208 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
    Annex C (informative) - Guide to marking and labelling
            requirements for ME EQUIPMENT and ME SYSTEMS
    Annex D (informative) - Symbols on marking
    Annex AA (informative) - Particular guidance and rationale
    Annex BB (informative) - Skin temperature at the PULSE
             OXIMETER PROBE
    Annex CC (informative) - Determination of ACCURACY
    Annex DD (informative) - Calibration standards
    Annex EE (informative) - Guideline for evaluating and
             documenting SpO[2] ACCURACY in human subjects
    Annex FF (informative) - Simulators, calibrators and
             FUNCTIONAL TESTERS for PULSE OXIMETER EQUIPMENT
    Annex GG (informative) - Concepts of ME EQUIPMENT
             response time
    Annex HH (informative) - Reference to the essential
             principles of safety and performance of medical
             devices in accordance with ISO/TR 16142
    Bibliography
    Alphabetized index of defined terms used in this standard

    Abstract - (Show below) - (Hide below)

    Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT.

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

    Committee TC 121
    Development Note Supersedes CSA Z9919. (03/2014)
    Document Type Revision
    Publisher Canadian Standards Association
    Status Withdrawn
    Superseded By
    Supersedes

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

    IEC TR 60825-9:1999 Safety of laser products - Part 9: Compilation of maximum permissible exposure to incoherent optical radiation
    IEC 60825-2:2004+AMD1:2006+AMD2:2010 CSV Safety of laser products - Part 2: Safety of optical fibre communication systems (OFCS)
    IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    C22.1-15 Canadian Electrical Code, Part I (23rd Edition), Safety Standard for Electrical Installations
    IEC TR 62471-2:2009 Photobiological safety of lamps and lamp systems - Part 2: Guidance on manufacturing requirements relating to non-laser optical radiation safety
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    IEC 60721-3-7:1995+AMD1:1996 CSV Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
    IEC 60601-1-10:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
    IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    IEC 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    EN 563:1994/A1:1999/AC:2000 SAFETY OF MACHINERY - TEMPERATURES OF TOUCHABLE SURFACES - ERGONOMICS DATA TO ESTABLISH TEMPERATURE LIMIT VALUES FOR HOT SURFACES
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    ISO 3534-2:2006 Statistics Vocabulary and symbols Part 2: Applied statistics
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    ASTM F 2761 : 2009 : R2013 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
    ISO 15223-1:2007 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    IEC 62471:2006 Photobiological safety of lamps and lamp systems
    IEC TR 60721-4-7:2001+AMD1:2003 CSV Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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