Makes sense to me, but we are not shipping to a customer on this side of the pond...
So the consensus is, that I write the power supply's D of C to conform to the LVD, and cite EN 60601-1 (the standard referenced in the unit's agency certifications and CB Report). thanks much, Brian >>>>>Would my customer (manufacturer of the end-use medical device) have any >trouble in Europe when the D of C for the unit's power supply is lists the >LVD?<<<< >After the power supply arrives at your customer's facility, no European >authority will ever ask to see the power supply DOC. Once the power supply >is installed in the end product, the only Declaration of Conformity of >interest to European authorities will be your customer's MDD declaration on >the overall product. >> Thanks for the ideas. But as the LVD specifically precludes medical stuff, >> how can I declare conformity? Has any NCB issued a "formal recomendation" >> for this particular combination? >A **power supply** is not a 'medical device', unless you intend it to be >used for ECT or electro-cautery or something similar. If it's a power >supply for any unspecified medical instrument, it's not, in itself, a >medical instrument.
