In general, the 3d edition of IEC60601-1 allows the use of 60950-approved components only as a means of operator protection. If the device must operate within an area of potential patient contact, there will be construction and performance requirements exceeding those specified in IEC60950-1.
While my employer has had customers that use our IT-approved component power supplies in medical apparatus, none of these end-use devices were intended to operate in the patient-contact area. Our sales people have been asked to encourage customers to use only 601-approved power supplies for use any medical apparatus. The (below) suggestion to use only 60601-approved components is re-emphasized. luck, Brian > -----Original Message----- > From: [email protected] [mailto:[email protected]]On Behalf Of Barker, > Neil > Sent: Tuesday, April 17, 2007 1:14 AM > To: 'Tarver, Peter'; PSTC 1 > Subject: RE: UL 60601-1, §56.4 > > > Peter, > > In my opinion this situation does not comply by virtue of the > words, "- > Capacitors shall not be connected between LIVE parts and > non-PROTECTIVELY > EARTHED ACCESSIBLE PARTS where the failure of such a > capacitor could result > in ACCESSIBLE PARIS becoming LIVE." > Since your power supply is double insulated, I would presume that any > conductive parts on the secondary side are not protectively earthed. > > Capacitors complying with IEC 60384-x are only accepted where > conductive > parts are also protectively earthed. "- Capacitors connected directly > between the MAINS PART and PROTECTIVELY EARTHED ACCESSIBLE > METAL PARTS shall > comply with the requirements of IEC Publication 384-14 or equivalent." > > You might find it helpful to use the 2006 version of the > standard as that > has made significant efforts to align certain parts with IEC 60950-1. > > I would also comment that there are manufacturers of plug-in or > lump-in-a-cord power supplies who have products certified to > IEC 60601-1, so > why go to the trouble of trying to use a 60950-1 certified > device? If you > contact me directly, I can point you towards such a manufacturer. > > Best regards > > Neil R. Barker CEng MIET FSEE MIEEE > Manager > Quality Engineering > e2v technologies (uk) ltd > 106 Waterhouse Lane > Chelmsford > Essex CM1 2QU > UK > > Tel: (+44) 1245 453616 > Fax: (+44) 1245 453571 > Mob: (+44) 7801 723735 - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] 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] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc ______________________________________________________________________ This email has been scanned by the MessageLabs Email Security System. For more information please visit http://www.messagelabs.com/email ______________________________________________________________________
