This blog will help you determine if and how the IEC 60601-1 Standard applies to your medical electrical product. Definitions, third-party testing, etc. discussed. One of the first questions clients ask before a project starts is, “Does this medical electrical product fall
2013 RAPS Regulatory Conf. Presentation – IEC60601-1 3rd ed., Managing Human Factors & Usability Risks
Join us at the 2013 RAPS Regulatory Convergence Conference (Boston) in the Medical Device Track on IEC 60601-1 Third edition: Managing Human Factors and Usability Risks. Your experts that will help you through these issues are Leo Eisner of Eisner
FDA Extends AAMI ES 60601-1 Transition Date to 31 Dec ’13 & Other Important Changes – Recognition Lists 031/032
The big news in the IEC 60601-1, 3rd ed. world today is the US National Standard that is in the FDA’s Recognized Consensus Standards Lists [Now is ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) – Recognition List #:
South Korea MFDS Amends it’s Medical Devices Act & Will Require IEC 60601-1, 3rd ed + Amendments
There were three major changes to South Korea’s Medical Devices Act and the Enforcement of the Medical Devices Act as of 8 May 2013.
Great Resource – Current/Draft IEC 60601/80601 Series of Stds & Test Rprts Now Available
We recently updated our website to make it easier for you to check the current IEC 60601 standards and the test report forms (TRFs) and you can check the status of draft standards and where in the process they are.