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,
AAMI ES60601-1:2005/C1:2009 –…
AAMI ES60601-1:2005/C1:2009 — Medical electrical equip, Gen rqrts for basic safety & essential performance, Amendment C1 http://ow.ly/1hMkV
RT @NIOSH: Noise & Hearing Los…
RT @NIOSH: Noise & Hearing Loss Prevention: Workplace Solutions from NIOSH http://go.usa.gov/l5i :Can assist w/ IEC 60601-1 noise rqrts
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