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About the EMC standard IEC60601-1-2:2014 "Edition 4", which will be mandatory from January 2019
Implementation of Medical Standard IEC60601-1-2:2014
IEC60601-1-2:2014 "Edition 4"
As already announced, the medical EMC standard "IEC60601-1-2:2014 (4th Edition)" will be mandatory from January 1, 2019.
(The current "IEC60601-1-2:2007 (3rd Edition)" will be invalid as of December 31, 2018.)
Therefore, for products intended for the European and U.S. markets after January 1, 2019, compliance with this new standard will be required.
For customers who are already shipping to Europe and the U.S. or are planning to do so, we recommend checking whether the AC adapter (power supply) you are currently selecting or considering complies with the new standard.
- This standard is based on international standards and differs from the domestic pharmaceutical law "JIS T 0601-1-2:2012".
- Unifive's medical AC adapters (UM305, UM312, UM315, UM318 series) for the European and U.S. markets are already compliant with the new standard.
For customers considering products for the European and U.S. markets, this is the ideal product.
New Product Information
In response to many customer requests, we began selling a medical product compliant with IEC60601-1: "USB Model" in July 2018.
We also respond to other requests such as "I want this kind of medical AC adapter…".
For more details, please feel free to contact our sales department.