Silvia, The external power supply should be tested together with the IVD device to ensure compliance of the combination to the emc, safety and other requirements depending on country of destination. For your information, the external power supply must also be certified in many countries. Refer to the following for a partial list of countries where external power supplies may be regulated for safety and/or emc
http://globalcompliance.blogspot.com/20 8/10/discussion-countries-regulating.html Best Regards, Peter --- On Wed, 2/4/09, Silvia Diaz Monnier <[email protected]> wrote: From: Silvia Diaz Monnier <[email protected]> Subject: In vitro diagnostic equipment with external power supply To: [email protected] Date: Wednesday, February 4, 2009, 4:15 AM Dear all, can anyone help me with this doubt? 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? Thank you. Best regards, __________________________________________________ Eng. Silvia Díaz Monnier NATIONAL INSTITUTE OF INDUSTRIAL TECHNOLOGY R & D Center of Telecommunications Electronics and Computer Science Te (+54 11) 4724-6369/6390 Fax (+54 11) 4754-5194/4064 [email protected] ___________________________________________________ 0800 444 4004 | www.inti.gob.ar - ---------------------------------------------------------------- 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]> - 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]>
