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    IEC62353

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    Jiju Narayan
    IEC 62353 is a standard for in-house electrical safety testing of medical equipment that does not require special laboratory conditions. It was introduced in 2007 as a safer alternative for clinical and service engineers to the more stringent IEC 60601 standard used by manufacturers. IEC 62353 specifies classification of equipment, tests to be conducted like earthbond testing, insulation resistance measurements, and leakage tests. It provides test methodologies and limits for ensuring electrical safety of medical devices during routine in-hospital use and maintenance.

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    IEC62353

    Uploaded by

    Jiju Narayan
    212 views16 pages
    IEC 62353 is a standard for in-house electrical safety testing of medical equipment that does not require special laboratory conditions. It was introduced in 2007 as a safer alternative for clinical and service engineers to the more stringent IEC 60601 standard used by manufacturers. IEC 62353 specifies classification of equipment, tests to be conducted like earthbond testing, insulation resistance measurements, and leakage tests. It provides test methodologies and limits for ensuring electrical safety of medical devices during routine in-hospital use and maintenance.

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    IEC 62353 is a standard for in-house electrical safety testing of medical equipment that does not require special laboratory conditions. It was introduced in 2007 as a safer alternative for clinical and service engineers to the more stringent IEC 60601 standard used by manufacturers. IEC 62353 specifies classification of equipment, tests to be conducted like earthbond testing, insulation resistance measurements, and leakage tests. It provides test methodologies and limits for ensuring electrical safety of medical devices during routine in-hospital use and maintenance.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    212 views16 pages

    IEC62353

    Uploaded by

    Jiju Narayan
    IEC 62353 is a standard for in-house electrical safety testing of medical equipment that does not require special laboratory conditions. It was introduced in 2007 as a safer alternative for clinical and service engineers to the more stringent IEC 60601 standard used by manufacturers. IEC 62353 specifies classification of equipment, tests to be conducted like earthbond testing, insulation resistance measurements, and leakage tests. It provides test methodologies and limits for ensuring electrical safety of medical devices during routine in-hospital use and maintenance.

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    IEC 62353

    Introduction
    Specially formulated for in house and routine electrical safety testing of medical equipment at hospitals Introduced by mid of 2007

    IEC 62353 doesn't need special laboratory conditions


    Safer for clinical and service engineers Formulated since routine testing doesn't need stringent testing as done by manufacturers

    IEC 62353

    Historical Perspective
    1960-1970: Increase in adoption and use of biomedical instrumentation in hospitals

    1970: Ralph Naders survey - 1200 patients in US were electrocuted


    annually during routine diagnosis 1976: Adoption of standards pertaining to the design, manufacture and/or testing of medical devices IEC 60601 and IS13450 standards: Applies to safety of medical equipments

    IEC 62353

    Physiological Effects of Electricity


    Muscle cramps Respiratory arrest

    Cardiac arrest
    Ventricular fibrillation Burns Electrolysis

    IEC 62353

    Electrical Safety: Patients Standpoint


    Application of electric circuits directly to the human body for diagnosis and therapy Absence of normal protection to currents provided by the patient's

    skin, if this is penetrated or treated to obtain a low skin resistance


    Absence of normal reactions of the patient who may be ill, unconscious, anaesthetized, immobilized etc Support or replacement of vital body functions may depend on the reliability of the equipment

    IEC 62353

    IEC 62353 Standard Equipment Classification

    According to the type of protection against electric shockPower Source

    Class I

    Equipment with exposed conductive parts connected to the protective earth in the fixed wiring of the installation

    Class II
    Internally Powered

    Equipment with additional protection to basic insulation, but having no direct connections to protective earth
    Equipment is powered from battery

    IEC 62353

    IEC 62353 Standard Equipment Classification

    According to the degree of protection against electric shockApplied Part

    F- Type

    Applied part which is electrically isolated from Earth and other parts of the medical equipment. i.e. floating

    B- Type
    BF- Type CF- Type

    Applied parts, which are usually Earth referenced. Not suitable for direct cardiac application. e.g. Dental chair
    Applied part complying with a higher degree of protection against electric shock than Type B applied parts. Not suitable for direct cardiac application. e.g. SPO2 Applied Part complying with the highest degree of protection against electric shock. Suitable for direct cardiac application. e.g. ECG monitor

    IEC 62353

    Tests Conducted

    Visual Inspection Earthbond Testing

    Insulation Measurements
    Leakage Measurements

    Equipment Leakage Applied Part Leakage

    IEC 62353

    Earthbond Testing

    Tests the integrity of the low resistance connection between the earth conductor and any metal conductive part (Class I Equipment) Earth bond resistance should be less than 0.3 ohm Test voltage to be applied - less than 24V Test current to be applied - +/- 200 mA constant

    IEC 62353

    Insulation Resistance Measurement

    This test is applicable to both CLASS I (earthed) and CLASS II (unearthed) equipments. During the measurement all switches of the MAINS PART shall be in operating position (ON). Insulation resistance measurements shall be performed with 500V (D.C.). Specifications Measurement : 1. EUT to Earth / Ground 2. AP to Ground Test voltage : 500V DC @1mA Safe limit : >100K

    IEC 62353

    Insulation Resistance Measurement


    Insulation resistance shall be measured between:
    A. B. C. D. E. Mains part and protective earth ( Class I only) Mains part and non-earthed accessible conductive parts Mains part and applied parts F-type applied part and protective earth ( Class I only) F-type applied part and nonearthed accessible conductive parts

    IEC 62353

    Leakage Tests

    Equipment leakage Current flowing from the mains part to earth via the protective earth conductor, accessible conductive parts of the enclosure and applied parts Measured by three different methods Direct method, Alternative method and Differential method Applied part leakage Current flowing from main parts and the accessible conductive parts of the enclosure to the applied parts Measured by two different methods - Direct method and Alternative method

    IEC 62353

    Leakage Tests
    a. Direct method
    Measures true leakage that would occur whilst the medical equipment is in typical use, this will give highest accuracy on low leakage current measurement. The DUT will be powered ON from mains through the analyzer
    Specifications Test Voltage Measuring Device : 230V, 50Hz : As per IEC 60601-1 requirements

    b. Differential method
    Measures the total leakage current and DUT does not need to be isolated during measurement. The DUT will be powered ON from mains through the analyzer and the measurement is taken as the difference between line and neutral currents
    Specifications Test Voltage Measuring Device : 230V, 50Hz : As per IEC 60601-1 (1KOhm)

    c. Alternative method
    This test provide highest safety for person doing the test. Here the supply inputs of the DUT will be shoted and an equivalent voltage generated by the analyzer will be connected as prescribed in the standard
    Specifications Test Voltage Measuring Device : 250V, 50Hz : As per IEC 60601-1 (1KOhm)

    IEC 62353

    Leakage Tests
    Equipment leakage a a Applied part leakage

    Internally Powered

    IEC 62353

    Leakage Current Limits


    Current in A Type B Applied Part Type BF Type CF

    Equipment Leakage current (Alternative method)


    Class 1 Class 2 Equipment Leakage current ( Direct or Differential method) Class 1 Class 2 Applied part Leakage current (Alternative method) Applied part Leakage current ( Direct or Differential method) 500 100 500 100 50 50 500 100 50 50 1000 500 1000 500 1000 500

    www.cdac.in

    IEC 62353

    Comparing IEC 62353 with IEC 60601

    IEC 60601
    Manufacturers type-test standard
    Need special laboratory condition Stringent measurement parameters

    IEC 62353
    Routine and in house testing of equipment
    No need of special laboratory condition Nominal measurement parameters suitable for routine testings

    IEC 62353

    CDAC-T and SCTIMST jointly developed Indias 1st indigenous medical electrical safety analyzer

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