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About Classification Exemption

Discussion in 'IEC 60601 - Medical Electrical Equipment Safety' started by Ata Arslanlı, Dec 18, 2018.

  1. Ata Arslanlı

    Ata Arslanlı New Member

    Dec 18, 2018
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    Hi! We have in a long-term discussion that we could not clear the point with some NotifiedBody.
    There is a ME1 device which is connected to mains plug (230 V - 50 Hz input) and totally reinforced insulated.
    The sample (ME2) is connected to a port on ME1 with 24 V DC.(ME2 is supplied via ME1)
    ME2 structure is also completely reinforced.
    A notified body claims that there is no classification for ME2.
    We think that the ME2 is also Class II. ( SELV is not a protection for 60601-1 according to Annex A. and there is no state for exemption.)
    Any ideas/experiences???