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    0001-Definitions-IEC - 60601-62353

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    edgar_dauzon
    This document defines commonly used terms within the IEC 60601 and IEC 62353 standards for medical electrical equipment. It defines key terms including equipment under test, applied part, patient connection, patient environment, and different types of applied parts. It also defines medical electrical equipment, medical electrical system, and equipment protection classes.

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    © All Rights Reserved
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    0001-Definitions-IEC - 60601-62353

    Uploaded by

    edgar_dauzon
    111 views2 pages
    This document defines commonly used terms within the IEC 60601 and IEC 62353 standards for medical electrical equipment. It defines key terms including equipment under test, applied part, patient connection, patient environment, and different types of applied parts. It also defines medical electrical equipment, medical electrical system, and equipment protection classes.

    Original Description:

    IEC60601, 62353

    Original Title

    0001-Definitions-IEC- 60601-62353

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    This document defines commonly used terms within the IEC 60601 and IEC 62353 standards for medical electrical equipment. It defines key terms including equipment under test, applied part, patient connection, patient environment, and different types of applied parts. It also defines medical electrical equipment, medical electrical system, and equipment protection classes.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    111 views2 pages

    0001-Definitions-IEC - 60601-62353

    Uploaded by

    edgar_dauzon
    This document defines commonly used terms within the IEC 60601 and IEC 62353 standards for medical electrical equipment. It defines key terms including equipment under test, applied part, patient connection, patient environment, and different types of applied parts. It also defines medical electrical equipment, medical electrical system, and equipment protection classes.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    Application Note 0001

    Title : Commonly used definitions within IEC 60601 – IEC 62353

    Equipment Under Test The equipment (EUT) which is the subject of testing.
    Device Under Test The equipment (DUT) which is the subject of testing.

    Applied Part Part of the medical equipment, which is designed to come into physical contact
    with the patient, or parts that are likely to be brought into contact with the
    patient.

    Patient Connection Individual physical connections and / or metal parts intended for connection
    with the patient, which form (part of) an Applied Part.

    Patient Environment Volumetric area in which a patient can come into contact with medical
    equipment or contact can occur between other persons touching medical
    equipment and the patient, both intentional and unintentional. (see Appendix E)

    F-Type Applied Part - Applied Part which is electrically isolated from Earth and other parts of the
    medical equipment. i.e. floating. F-type Applied Parts are either type BF or type
    CF Applied Parts.

    Type B Applied Part Applied Part complying with specified requirements for protection against
    electric shock. Type B Applied Parts are those parts, which are usually Earth
    referenced. Type B are those parts not suitable for direct cardiac application.

    Type BF Applied Part F-Type Applied Part complying with a higher degree of protection against
    electric shock than type B Applied Parts. Type BF Applied Parts are those
    parts not suitable for direct cardiac application.

    Type CF Applied Part F-Type Applied Part complying with the highest degree of protection against
    electric shock. Type CF Applied Parts are those parts suitable for direct
    cardiac application.

    Medical Electrical Equipment Electrical equipment, designed for treatment, monitoring or


    diagnoses of patients, powered from not more than one connection to mains
    supply and which are necessarily in physical or electrical contact with the
    patient or transfers energy to or from the patient or detects such energy transfer
    to or from the patient.

    0001-Definitions IEC 60601-62353.doc Page 1 of 2


    Medical Electrical System Combination of equipment of which at least one is classed as
    medical electrical equipment and as such specified by the manufacturer to be
    connected by functional connection or use of a multiple portable socket-outlet.

    Class I Equipment protection against electric shock by (earthed) additional protection


    to basic insulation through means of connecting exposed conductive parts to
    the protective Earth in the fixed wiring of the installation.

    Class II Also referred to as Double Insulated. Equipment protection against electric


    shock by additional protection to basic insulation through means of
    supplementary insulation are provided, there being no provision for the
    connection of exposed metalwork of the equipment to a protective conductor
    and no reliance upon precautions to be taken in the fixed wiring of the
    installation.

    NOTE C L ASS II EQUIPMENT may be provided with a FUNCTIONAL E ART H


    T ERMINAL or a F UNCTIONAL EARTH CONDUCTOR .

    End.

    0001-Definitions IEC 60601-62353.doc Page 2 of 2

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