Gentlemen 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?
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? thanks much, Brian <3E5C9943.14190.33FECD@localhost>) about 'D of C for medical P.S.' on Wed, 26 Feb 2003: >You are right not issuing a D of C to the MDD, as your product is not a medical >device or an >accessory ot a medical device. > >On the other hand I see no reason not to issue a D of C to the LVD. Compliance >with a standard in >the list of Harmonised Standards is not the only way to demonstrate compliance >with the LVD. It >does not take very much effort to draw up a comparison table showing that the >requirements for a >power supply in IEC 60601-1 are more stringent than say, IEC 60950 or IEC >61010-1. Using >engineering judgment on this basis, I believe that you can issue a D of C to the >LVD, specifying >IEC 60601-1 as the applied standard. You can present your comparison table to >anyone who questions >this, demonstrating the engineering basis for your declaration. That's what I would recommend, but I don't know enough about 60601-1 to be definite. -- Regards, John Woodgate
