The FDA is to Formally Recognize the Medical Electrical Safety Standard IEC 60601-1:2005, 3rd ed From AAMI March 12, 2010 press release The U.S. Food and Drug Administration (FDA) will formally recognize the electrical equipment standard IEC 60601-1/Ed.3:2006.
ANSI/AAMI/IEC TIR62354:2009 – Coming Soon
ANSI/AAMI/IEC TIR62354:2009 — General testing procedures for medical electrical equipment – Coming Soon (IEC version already published) This Technical Report will specify the general harmonized recommendations (conditions and procedures) for testing MEDICAL ELECTRICAL EQUIPMENT (as defined in Sub-clause 3.63 of
ANSI/AAMI/IEC TIR80002-1:2009 published Dec ’09
ANSI/AAMI/IEC TIR80002-1:2009 — Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software – Published Dec 24, ’09 Abstract: This technical specification provides information useful for the performance of effective software risk management,
TÜV SÜD Info Newsletter on MDD declarations of conformity required – yes or no?
In the April 2009 edition of our medical information flyer ‘Transition to EC Directive 2007/47/EC’, we informed you that we assumed, in view of the status of discussions at that time, that new declarations of conformity would have to be
New BSI Standards Development website
New BSI Standards Development website (source BSI Quality Management Newsletter Feb 2010) Search through standards currently in development and monitor their progress Discover and comment on proposals for new standards and draft standards Find out which trade associations and professional