In message <7D5194F9B0004EAC91A4550B22CF7FBF@MAFALDA>, dated Wed, 4 Feb 2009, Silvia Diaz Monnier <[email protected]> writes:
>A in vitro diagnostic equipment will be tested according to EN >61010-2-101 to bear CE marking under IVD Directive. It has an external >power supply from another manufacturer that bears a CE Marking under LV >Directive, tested by EN 60950-1. The external power supply provides 12 >Vdc to the IVD equipment and will be sold with it. It is allowed to >assume the power supply is an approved critical component or should the >power supply be tested together with IVD equipment? The latter: you are selling a 'system', composed of the diagnostic unit and its power supply. The manufacturer CAN test them (or have them tested) together so they MUST be tested together. Although the above uses terms from the 1989 EMC Directive, it logically applies generally, not just to EMC. -- OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk Things can always get better. But that's not the only option. John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
