There is additional information, including how collateral and particular standards will be treated and how US National infrastructure requirements enacted as statue (e.g. NFPA 99) will be implemented with this Standard, and how Risk Management will be used with this standard, on the FDA Consensus Standard web page for ANSI/AAMI Es 60601-1:2005 http://ht.ly/22kSQ

Abstract: This technical specification provides information useful for the performance of effective software risk management, as part of the overall risk management process for medical devices containing software. It does this in the context of ISO 14971:2007, Medical devices – Application of risk management to medical devices and in the context of ISO/IEC 62304:2006, Medical device software – Software life cycle processes. Elements not to be covered include areas already covered by existing or planned standards, e.g., alarms, human factors engineering, networking, etc. (80002-1).  Identical to IEC/TR 80002-1

On October 27, 2009, Leo Eisner, of Eisner Safety Consultants and the Chair of the Medical Track for this Symposium, will be presenting a regulatory update on IEC 60601-1, 3rd edition at the 2009 IEEE Symposium on Product Safety Engineering Society. This presentation will be part of a whole day medical track which will include speakers from the FDA, IEC TC 210 Convener (ISO 14971), experts on the IEC 60601-1, human factors, etc. and will have two panel discussions as well.

UL webpage with regard to ISO 14971 – Risk Management.  Go to the bottom of this UL webpage & log-in to get a case study evaluating why a company may want ISO 14971 certification to support IEC 60601-1:2005 (3rd ed), which has heavy emphasis on ISO 14971.