Battery chargers are dependent on intended end use, and if tested to 60601-x, may not meet some critical requirements that are specified in product safety standards scoped for chargers.
The 3d ed of 60601-1 says IT equipment power supply is ok to use for certain types of medical equipment, typically where MOPP not required. So it is obvious that these units may not have a DofC to the MDD. Again, the DoC should not necessarily be the salient document for components. Look at the test standard and test report for the component to determine suitability. Brian > -----Original Message----- > From: emc-p...@ieee.org [mailto:emc-p...@ieee.org]On Behalf Of Jon > Griver > Sent: Tuesday, January 12, 2010 10:11 AM > To: emc-p...@ieee.org > Subject: External power supplies covered under Medical > Device Directive? > > Pat, > > The definition of 'accessory' is discussed in the guidance > document MEDDEV 2.1/1 > at: > http://ec.europa.eu/enterprise/sectors/medical-devices/files/ > meddev/2_1-1___04-1994_en.pdf > > My understanding of this document is that if the > manufacturer of the power supply > does not specify one or more specific medical devices for > which it is an accessory, > then it cannot be approved separately under the MDD. > > If, however, the power supply manufacturer specifies > 'intended use' of specific devices, > then it can be approved to the MDD as an accessory. Several > examples are given in > the guidance document, including "specific battery chargers > for battery driven electromedical > devices". > > Regards, > > Jon Griver > http://www.601help.com > The Medical Device Designer's Guide to IEC 60601-1 > > 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>
