IEC 60601-1 sets general requirements for basic safety and essential performance of medical electrical equipment. The third edition of the complex standard sees major changes from the second edition. While Canada, Europe, and the U.S. are in various stages of implementing the IEC standard, there is some progress towards harmonization.
Eisner Safety Consultants recently reported on a piece published in FDA News Devices & Diagnostic Letter. "US Devicemakers Given Three Year Transition to IEC 60601-1" reports that CDRH has adopted the international standard last month.
Why the relatively long three-year transition? One reason would be the scope of changes: The third edition includes a whopping 114 subclauses that are not contained in the second edition.
For more information on IEC 60601-1 3rd Edition, take a look at:
- Regulatory strategies for IEC 60601
- Eisner Safety Consultants' blog
- How to Mark & Label Devices Under IEC60601-1 3rd Edition
Follow us on Twitter at @fxtrans to get your daily dose of multilingual compliance news.