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/Lex riServ.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>
