Dear all, the standard IEC/EN 60601-1-2 Am. 1 prescribes the manufacturer of a medical electrical equipment to declare the essential performances in the accompanying documents.
As far as I know the Amendment is not mandatory yet (as an EN standard it has not been published in the EU Official Journal yet, among the standards giving presuntion of conformity for MDD 93/42/EEC; and it seems that FDA will accept conformity to IEC 60601-1-2 without Amendment 1 until March 1 2009). Anyway, I wonder if any of you has already experienced it, and what a reviewer or an auditor expects to find in the accompanying documents in your opinion (very generic statements coming from the standard definitions, or very detailed information on how the system is expected to behave in order to maintain an acceptable level of residual risk). Thanks, 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 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 email has been scanned by the MessageLabs Email Security System. For more information please visit http://www.messagelabs.com/email ______________________________________________________________________
