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 www.ScripRegulatoryAffairs.com Everything you needed to know about who’s doing what where with IEC 60601-1 – Part 1 – Published 11 June 2015 in Scrip Regulatory Affairs Article discusses how the standard (IEC 60601-1 3rd ed. or ed. 3.1) is being used by Regulatory & Standards Organizations for the USA and Canada. Bookmark and Share
JMDR May 2012 issue Cover Page Update on National Implementations of IEC 60601-1:2005 – Published May 2012 in the Journal of Medical Device Regulation Article discussed the National Implementation of IEC 60601-1:2005 into the National Regulatory schemes for the EU, Canada, USA, and Brazil. Bookmark and Share
Regulatory Strategies for the Third Edition of IEC 60601-1 — Published September 2009 in MD&DI Article discusses when IEC 60601-1:2005 will be mandatory, including the US, EU, and Canadian National versions of the standard. Bookmark and Share
A New U.S. National Standard for Medical Devices — Published September 2006 in MD&DI Article discusses the new US standard ANSI/AAMI ES 60601-1:2005 including the history of US medical electrical device standards, a summary of the national deviations., and discussion of leakage current issues. Bookmark and Share
IEC 60601-1 – The Third Edition — Published May 2006 in Journal of Medical Device Regulation Article covers IEC 60601-1 and its’ major changes including amended scope, modification of medical electrical equipment definition, inclusion of risk management, essential performance, and impact on manufacturers & certification bodies. Bookmark and Share
Risk Management Implications of IEC 60601-1, 3rd Ed. — Published January 2005 in CE Discusses that manufacturers should gear up to change their practice of risk management in engineering medical electrical equipment per the upcoming IEC 60601-1, third edition Bookmark and Share
A Regulatory Review of the EMC Standard for Medical Devices — Published January 2005 in CE Discussion for manufacturers to get prepared for tougher requirements now that the second edition of IEC 60601-1-2 is supplanting the first. Bookmark and Share
Safety Requirements: Understanding IEC 60601-1 — Published Fall 2004 in MEM This article explains the IEC 60601-1 standard, the series, national standards, structure of base standard, & basic concepts including classifications. Bookmark and Share
 Leakage Current Standards Simplified — Published July 2004 in MD&DI IEC 60601-1 and related standards provide detailed explanations of testing strategies for leakage current. Understanding those tests and applying them effectively is a critical aspect of making electromedical equipment. Bookmark and Share
IEC 60601-1: Medical Device Marking and Labeling — Published May 2004 in MD&DI This article discusses how IEC 60601-1 treats labeling as a critical component of medical devices and provides comprehensive requirements for marking and labeling. Bookmark and Share
National Deviations to IEC 60601-1 — Published February 2004 in MD&DI This articles discusses the national deviations to the U.S., Canadian, and Australian requirements related to IEC 60601-1, 2nd ed. Bookmark and Share
A Primer for IEC 60601-1 — Published September 2003 in MD&DI This article discusses the process of “designing in” safety is a must to ensure that electrical medical products (IEC 60601-1) succeed in meeting both regulatory requirements and market prospects. Projects are often delayed due to underestimating the product safety requirements in the initial design phase. Bookmark and Share

Finding and Using Electrical Safety Testing Resourcesauthored 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