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    I.S. EN ISO 80601-2-61:2011

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Superseded date:  16-02-2019

    Language(s):  English

    Published date:  01-01-2011

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    Foreword
    Introduction
    201.1 Scope, object and related standards
    201.2 Normative reference
    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 S[p]O[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
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC

    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)

    Development Note Supersedes I.S. EN ISO 9919. (05/2011)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    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
    CLSI C46 A2 : 2ED 2009 BLOOD GAS AND PH ANALYSIS AND RELATED MEASUREMENTS
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    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
    CLSI C25 A : 1997 FRACTIONAL OXYHEMAGLOBIN, OXYGEN CONTENT AND SATURATION, AND RELATED QUANTITIES IN BLOOD: TERMINOLOGY, MEASUREMENT, AND REPORTING
    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
    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
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    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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