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	Recent article authored by Leo Eisner, Dan Modi, Mike Schmidt and Frank O'Brien published in MD&DI: A New U.S. National Standard for Medical Devices -- September 2006
	Article authored by Leo Eisner, Charles Sidebottom, Harvey Rudolph, and Michael Schmidt in Journal of Medical Device Regulation: "IEC 60601-1 – The Third Edition" -- May 2006
Articles authored by Leo Eisner, Dan Modi and Bob Brown published in MD&DI, MEM, & CE:
	"Risk Management Implications of IEC 60601-1, 3rd Ed." -- January 2005 issue CE.		"A Regulatory Review of the EMC Standard for Medical Devices" -- January 2005 issue CE.
	"Safety Requirements: Understanding IEC 60601-1" -- Fall 2004 issue MEM.		"Leakage Current Standards Simplified" -- July 2004 issue MD&DI.
	"IEC 60601-1: Medical Device Marking and Labeling" -- May 2004 issue MD&DI.		"National Deviations to IEC 60601-1" --February 2004 issue MD&DI.
	"A Primer for IEC 60601-1" -- September 2003 issue MD&DI.

"Finding and Using Electrical Safety Testing Resources" authored by James Richards and published in Compliance Engineering 

We are Pleased to Present a Series of Articles on IEC60601-1 the International Standard for Electro-Medical Equipment  in Cooperation with QuadTech

• At last, in this final installment, specific parameters from Nationals standards are highlighted and their differences from IEC 60601-1 are detailed. A short discussion on medical device approval is provided also.

• The seventh in the series explains Leakage Currents - Part 2   Part 2 builds on the basic principles and details from the Part 1 article of IEC60601-1 measurement circuits for Earth, Touch/Chassis and Patient leakage current tests.

• The sixth in the series explains Leakage Current concepts for medical device requirements - This is part 1 of 2

• The fifth in the series explains production line electrical safety tests (EST)  (pdf file 126Kb)

• The fourth in the series explains the Classification system used in IEC60601-1 (pdf file 151 Kb)

• The third in the series looks at litigation risks and market recognition as drivers for why you should use IEC60601-1.  The article is titled "IEC60601-1 and Your Electrical Medical Product" (pdf file 137Kb)

• The second in the series explains the legal requirements for  “Why Product Safety Testing for Your Electrical Medical Products? ” (pdf file 464 Kb)

• The first part in this series provides an overview of the  IEC60601 series of standards  Overview of IEC60601-1 (pdf file 40Kb)
  
  
  

Check out our additional product safety articles and information, Agency News, European Union News and information, Quality System News and Information, and FDA News

The previously featured article titled "European Union - Analysis for Medical Devices (Updated 11/16/00)" has been moved to the European Union News Page.