1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

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

    Joined:
    Dec 18, 2018
    Messages:
    1
    Likes Received:
    0
    Trophy Points:
    1
    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???