< 1 min reading time Hi! We’ve been having a long discussion with a Notified Body and we aren’t satisfied with the answer. There is a ME1 device which is connected to mains plug (230 V – 50 Hz input) and is totally reinforced and insulated. The sample (ME2) is connected to a port on ME1 with 24 V DC.(ME2 is supplied via ME1). The ME2 structure is also completely reinforced. The NB claims there is no ME2 classification. We think ME2 is Class II. (SELV is not a protection for 60601-1 according to Annex A and there is no stated exemption.) Can you advise? Marked as spam  Posted by Asked on December 19, 2018 6:57 am 184 views |
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 Private answer Christine Zomorodian Ata, should we assume that you are referring to the classification under the IVDR? Marked as spam |
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