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FDA extends 60601-1-2 ed. 4 implementation again

July 8, 2016

In July 2014, FDA added the IEC 60601-1-2:2014 (4th edition) “Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests” to the list of standards that can be used to show EMC compliance for medical electrical devices and systems. The transition at that time was August 2016. In November 2014, FDA revised this date to April 1, 2017.

Recently, FDA published a new date for the recognition to December 31, 2018. At that time, medical device manufacturers must demonstrate compliance to the 4th edition of IEC 60601-1-2. This date aligns with the current European Union medical devices directive (MDD 93/42/EEC).

Link to the Federal notice: