Acceptance Mark
IEC60601-1-2 4.1
Major Changes in IEC60601-1-2 Edition 4.1

In September 2020, the revision of the fourth edition of the medical device EMC standard IEC 60601-1-2 was released, and the latest standard became IEC 60601-1-2 edition 4.1. This new version has a three-year implementation transition period to completely replace version 4.0 of the standard. From December 17, 2023, the US Food and Drug Administration (FDA) will no longer accept IEC 60601-1-2 4.0 testing and reporting.

The following are the main changes in IEC60601-1-2 Edition 4.1.

     According to CISPR 11, the input voltage range value is greater than 25%, then the power terminal conduction, voltage drop and short-time interruption test items need to evaluate the minimum input voltage and maximum input voltage.
     If the power supply frequency of medical equipment and medical system matches, the power frequency magnetic field only needs to evaluate and test one of 50Hz or 60Hz.
     For circuits containing magnetic sensitive components, it is necessary to evaluate the IEC 61000-4-39 magnetic field immunity test project, which requires 9kHz to 56 MHz.