- 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.
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.
- 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.
- 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.
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.
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.
- 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.
- 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.
- 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.
- 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.
- National Deviations to IEC 60601-1Published 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.
- 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.
- 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)
- The fourth in the series explains the Classification system used in IEC60601-1
- 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
- The second in the series explains the legal requirements for Why Product Safety Testing for Your Electrical Medical Products?
- The first part in this series provides an overview of the IEC60601 series of standards Overview of IEC60601-1