IEC 60601-1 has become the global benchmark for medical electrical equipment, and many device companies view compliance with IEC 60601-1 as a de facto requirement for most markets.
The third edition of IEC 60601-1 was published in December 2005 but implementation has been slow. One of the reasons is that the third edition is so different from the second edition.
Risk management is inextricably woven into the fabric of this standard. Not only is there a general requirement for manufacturers to establish a risk management process that conforms to ISO 14971 (clause 4.2), but there are also more than one hundred times where the standard directs manufacturers to determine risk acceptability in applying a particular clause.
Certifiers and manufacturers alike are wondering how countries around the world will transition to their national versions of 60601-based collateral and particular standards.
Our colleague and collaborator Leo Eisner gives his view in the current issue of MD&DI. Regulatory Strategies for the Third Edition of IEC 60601-1 provides a good look at the current state of affairs in the U.S., Canada, and Europe.
The upshot is that requirements are all over the map. Over the next two to three years, device manufacturers will need to make sense of these conflicting requirements and different versions of the standard. It promises to be an interesting time!
For more information visit:
- Eisner Safety Consultants' blog
- How to Mark & Label Devices Under IEC60601-1 3rd Edition
- Medical device risk management - best practices for implementation
- IEC's extensive reference section for 60601
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