Eisner Safety Consultants

Regulatory Strategies for the Third Edition of IEC 60601-1 — Published September 2009 in MD&DI

The article discusses when IEC 60601-1:2005 will be mandatory, including the US, EU, & Canadian National versions.  There is a look at the development of the standard and why implementation has taken so long.  As there can be conflicting requirements for the manufacturers the article discusses the steps to consider in developing a company strategy to transition from second to third edition for its product lines. This last item is a special segment in the web version only.