A Closer Look at IEC 60601-1-2: 2014 (4th Edition)
In February 2014, the IEC (International Electrotechnical Commission) published IEC 60601-1-2:2014 Edition 4, replacing the IEC 60601-1-2 Edition 3 published in 2007. It pertains to EMC for medical electrical equipment and medical electrical systems.
The FDA now recognizes the 4th edition and the mandatory compliance date for new submittals was December 31, 2018, which means all new devices should now comply.
In this whitepaper, Review of IEC 60601-1-2: 2014 (4th Edition), EMC expert Darryl P. Ray digs into the new edition and summarizes the differences you need to know about. Make sure you’re aware of the significant changes to:
- Test Levels
- Immunity Pass/Fail Acceptance Criteria
- The Modes of Operation, and More
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