• BS 5724-2.31(1995) : 1995

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE

    Available format(s): 

    Superseded date:  31-07-2009

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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

    Committees responsible
    National foreword
    Foreword
    Introduction
    Section One: General
    1. Scope and object
    2. Terminology and definitions
    5. Classification
    6. Identification, marking and documents
    7. Power input
    Section Two: Environmental conditions
    Section Three: Protection against electrical shock hazards
    14. Requirements related to classification
    19. Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY
         CURRENTS
    Section Four: Protection against mechanical hazards
    Section Five: Protection against hazards from unwanted
    or excessive radiation
    36. Electromagnetic compatibility
    Section Six: Protection against hazards of ignition of
    flammable anaesthetic mixtures
    Section Seven: Protection against excessive temperatures
    and other safety hazards
    44. Overflow, spillage, leakage, humidity, ingress of
         liquids, cleaning, sterilization and disinfection
    49. Interruption of the power supply
    Section Eight: Accuracy of operating data and protection
    against hazardous output
    50. Accuracy of operating data
    51. Protection against hazardous output
    Section Nine: Abnormal operation and fault conditions/
    environmental tests
    Section Ten: Constructional requirements
    56. Components and general assembly
    Figures
    101 Measuring circuit for the MAXIMUM TRACKING RATE
    102. Initial oscilloscope display when measuring
          MAXIMUM TRACKING RATE
    Appendix/Annexes
    Appendix L. References - Publications mentioned in this
                 Standard
    Annex AA General guidance and rationale
    Annex BB Bibliography
    Annex ZA (normative) Other international publications
              quoted in this standard with the references
              of the relevant European publications
    Annex ZB (informative) Other international publications
              quoted in this standard with the references of
              the relevant European publications

    Abstract - (Show below) - (Hide below)

    ALSO NUMBERED AS BS EN 60601 PT2-31. Specifies the particular safety requirements for external pacemakers powered by an internal electrical power source. Not applicable to equipment which can be directly or indirectly connected to a supply mains. Does not apply to pacing leads, or other equipment for cardiac stimulation which either: provides antiachycardia therapy beyond high burst pacing; or forms an integral part of equipment with other functions; or applies the stimulus across the thorax externally or in the oesophagus; or provides pacing system analysis functions.

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

    Committee CH/150/6
    Development Note Supersedes 91/53412 DC. (11/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    EN 50061 : 88 AMD 1 95 SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS
    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
    IEC 60086-2:2015 Primary batteries - Part 2: Physical and electrical specifications
    IEC 60086-1:2015 Primary batteries - Part 1: General
    ISO 5841-1:1989 Cardiac pacemakers Part 1: Implantable pacemakers
    BS EN 60801-2:1993 Electromagnetic compatibility for industrial-process measurement and control equipment Electrostatic discharge requirements
    NFC 74 308 : 1988 ELECTROMEDICAL EQUIPMENT - ELECTRICALLY-OPERATED PACEMAKERS
    IEC 60801-2:1991 Electromagnetic compatibility for industrial-process measurement and control equipment - Part 2: Electrostatic discharge requirements
    BS EN 60601-1-2:2015 Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests
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