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Surrogate for thermal performance testing

  • 1.  Surrogate for thermal performance testing

    Posted 19-Feb-2013 17:19
    Does anyone know what surrogate media or test devices FDA has accepted in lieu of human subjects for meeting compliance to IEC 60601-1-2 section 201.15.101.5 NE Thermal Performance?

    IEC 60601-1-2 section 201.15.101.5 NE Thermal performance states:

    "For NES intended for use on small patients, these tests may be performed on adult subjects. The test surface to which the NE under test is applied shall be the skin of human subjects, electrically and thermally equivalent surrogate media or test devices."

    Thanks,

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    Judy Burton
    Advena USA
    Dallas TX
    United States
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