D of C for *component* power supply to LVD, where the specified presumption of conformity is 60601-x report.
D of C for power source that can be used as separate device (not necessarily incorporated into end-use equipment) to MDD where the unit meets all requirements for intended usage in accordance with all applicable 60601-x. I feel that we get too worked up about DofCs for components. The important docs for components are the test standard and the test report. Brian > -----Original Message----- > From: emc-p...@ieee.org [mailto:emc-p...@ieee.org]On Behalf Of > pat.law...@slpower.com > Sent: Tuesday, January 12, 2010 9:14 AM > To: emc-p...@ieee.org > Subject: External power supplies covered under Medical > Device Directive? > > Good morning, > > I'm having a discussion with a co-worker concerning whether > external power > supplies powering medical equipment (like blood-pressure > monitors) are > covered under the Medical Device Directive. The power > supplies are tested > & approved to the appropriate medical standards -- only the > format of the > Declaration of Conformity is being discussed. The MDD 93/42EC is at > < > http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG :1993L0042:20071011:EN:PDF > My co-worker feels power supplies do not fall under the MDD due to Article 1, section 2a. Paraphrasing, it says the Directive covers devices that provide a medical function. This would be the equipment powered by our product. While I agree external power supplies don't provide a medical function, I think they fall under the MDD as an 'accessory', as described in section 2b and section 1. Opinions? Links to interpretation papers? Pat Lawler EMC Engineer SL Power Electronics Corp. - 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 <emc-p...@ieee.org> 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 <emcp...@socal.rr.com> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com>
