In February 2014, the International Electrotechnical Commision introduced the 4th edition of IEC 6061-1-2:2014 for medical electrical equipment. The fourth edition of this harmonized standard cancels and replaces the third edition of IEC 60601-1-2, published in 2005, and implies the significant technical revisions such as new risk analysis and immunity requirements.
The new edition may have a dramatical impact to the medical industry and presents several challenges relating to the design, EMC testing and documentation to the medical devices.
So what are the new changes? And how this new edition will affect your business? Here we look at the recent 4th Edition and its effect on the EMC Compliance for medical devices.
The most significant changes with respect to the 3rd edition include the following:
- Immunity test levels are categorized according to use location (not device type);
- The “life supporting equipment” category has been removed;
- Test Plan & Test Report are required;
- EMC must be addressed in the Risk Management documentation;
- Radiated Immunity levels vary depending on use location;
- Radiated Immunity Test Levels have been changed;
- New procedures for devices damaged during immunity testing;
IEC 60601-1-2 applies to the essential performance and basic safety of medical electrical equipment and medical electrical systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by the above equipment. This International standard is the primary standard used for electromagnetic compatibility testing.
The new edition reshapes the medical environments by categorizing the immunity levels according to use location and by implementing the increased levels for radiated immunity. Additionally, the compliance criteria now depend on the Risk Managementof a manufacturer and the compliance with IEC 60601-1-2: 4th Edition requires, therefore, a close coordination process between a test laboratory and a manufacturer.
Technical Content of the IEC 60601-1-2:2014
- Normative references;
- Terms and definitions;
- General requirements (Risk Management process for Medical Electrical Equipment and Systems, General Test Coditions);
- Medical Electrical Equipment and Systems identification, marking and documents;
- Documentation of the tests (Test Plan & Test Report);
- Electromagnetic Emissions requirements for Medical Electrical Equipment and Systems;
- Electromagnetic Immunity requirements for Medical Electrical Equipment and Systems;
- Test report.
Are you ready for 60601-1-2: 4th Edition?
In Europe, the withdrawal date of the 3rd Edition is expected in the 2017-2018 timeframe. The estimated compliance date of EN 60601-1-2:2014, is December 31st 2018. However, this date will be finalized upon the information being published in the European Official Journal. After the published date, all medical devices sold to the EU must comply with the new standard.
It is highly recommended for all new medical devices to be in compliance with the IEC 60601-1-2 4th Edition!
Contact us to learn more about the compliance with the IEC 60601-1-2: 4th Edition.
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