< 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
|
Meet your next client here. Join our medical devices group community.
Private answer
Christine Zomorodian
Ata, should we assume that you are referring to the classification under the IVDR? Marked as spam
|