Brian, 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. Regards, Jon Griver http://www.601help.com On 25 Feb 2003 at 13:40, [email protected] wrote: > > Good people of PSTC > One of our custom (component) SMPS is evaluated/certified to IEC/EN60601-1. The LVD precludes > medical stuff, and the MDD is ambiguous on "components" or "materials" being scoped by the MDD. > The customer has determined that indicated conformance should be the LVD. If the unit's D of C > claims conformance to the LVD, then there is no applicable standard, within the scope of the LVD > that can be stated. > So what is the correct content of the unit's Declaration of Conformity? Can anyone please cite > normative OJ guidance? > thanx much. > R/S, > Brian This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
