Fourth Edition of IEC 60601-1-2 Tightens EMC Requirements for Medical Devices
The fourth edition of the IEC 60601-1-2:2014 standard is out, introducing significant technical changes in electromagnetic compatibility (EMC) requirements and tests for medical equipment and systems.
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The main goal of the EMC changes is to make sure medical devices do not affect patient safety in the increasingly complex environment. Contrary to previous versions, the new version of the standard defines tests and limits according to risk and intended use instead of device type. In our latest whitepaper penned by TÜV Rheinland EMC Experts, we aim to address some of the changes.
Compliance to the new standard is expected to be set at the following timeframe:
- April 2017 in the USA for all products; existing products will need to comply if changes are made, effective, April 2017.
- The US Food and Drug Administration (FDA) already officially accepts the fourth edition, and there have been reports that the FDA is asking for it now on new 510(k) applications.
- The expected date of compliance for EU is expected to be set at August 2017, pending the standard being published in the Official Journal. Official deadline is likely to be set in the next few months.
Here is a look at what is inside this whitepaper:
- New EMC Philosophy
- New Responsibilities for the Manufacturer and Test Lab
- Summary of Technical Changes
- Additional Considerations
- Testing Cost Impact
- And more!