Thank you Dave. Now, the third edition of IEC 60601-1 has new requirements for flammability (section 11.3) which are similar to those in old UL 60601-1, but they don't seem to be necessarily mandatory:
"This subclause provides an alternative means of compliance with selected HAZARDOUS SITUATIONS and fault conditions as identified in 13.1.2. In doing so, the following constructional requirements shall be met or specifically analyzed in the RISK MANAGEMENT FILE and if not met, specific justification shall also be given. " So, if ANSI/AAMI 60601-1 does not add anything to the IEC standard, does it mean we will not have to care about plastic materials flammability in ME equipment, provided a specific justification will be given in the risk management file? Regards, Paolo Peruzzi Regulatory Medical R&D El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI) Italy Tel. +39 055 8826807 FAX +39 055 8832884 [email protected] http://www.elengroup.com/ El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI) Italy Tel. +39 055 8826807 FAX +39 055 8832884 http://www.elengroup.com/ From: Dave Osborn <[email protected]> To: Paolo Peruzzi <[email protected]> Sent: Wed, 9 Apr 2008 18:00:59 -0400 Subject: Re: ANSI/AAMI 60601-1 flammability requirements > Hello Paolo, > > They do not > > Best regards, > > Dave Osborn > Manager, International Standards > Philips Healthcare > 3000 Minuteman Road Bldg 4 > Andover, MA 01810 > PMS-158 3178 > Tel: +1 978 659 3178 > Fax: +1 978 659 3819 > E-mail: [email protected] > > To emcpstc <emc- > [email protected]> > cc Paolo Peruzzi > <[email protected]> > Subject > ANSI/AAMI 60601-1 flammability Sent by: > requirements [email protected] > Classification > > 04/09/2008 12:03 PM > > Dear all, > Does anybody know whether the US deviations to the latest IEC 60601-1 > (ANSI /AAMI ES 60601-1: 2005) retain the same prescriptions of the > previous UL 60601-1 about flammability for medical electrical equipment > plastic covers (minimum 94 V-0 for fixed equipment and minimum 94 V-2 > for transportable ones)? > Thank you, > > Paolo Peruzzi > > Regulatory Medical R&D > El.En. S.p.A. > Via Baldanzese, 17 > 50041 Calenzano (FI) > Italy > Tel. +39 055 8826807 > FAX +39 055 8832884 > [email protected] <mailto:[email protected]> > http://www.elengroup.com/ > > - > ---------------------------------------------------------------- > 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 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
