IEC 60601-1-2:2014 Edition 4 was published February 2014. Edition 4 creates a safety standard that relates to electromagnetic disturbances, to align with the general requirements of IEC 60601-1 Edition 3.
It is thought that the EC 60601-1-2 did not adequately address the safety aspects as related to electromagnetic interference.
The FDA now recognizes the 4th edition and the mandatory compliance date for new submittals is December 31, 2018, this complements the requirements of the EU (EN 60601-1-2:2015). Although not mandatory until 2018 the FDA is currently accepting the 4th edition and with new applications prefers products (especially for devices to be used in the home healthcare environment) to be tested to that standard.
Compliance to the 4th edition for legacy devices, unless substantial changes are made to the product, is not required by the FDA.
The Date of Withdrawal (DoW) of EN 60601-1-2:2007 is published as December 31, 2018, in the European Union. Subsequently, devices manufactured and imported into the EU after that date are required to comply with the 4th edition. There is no allowance for legacy devices.
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