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EM Safety; EU and FDA effective dates

posted Aug 3, 2016, 10:46 AM by Frank O'Brien   [ updated Aug 3, 2016, 11:34 AM ]
The FDA recently extended the effective date for the EM Disturbances collateral, IEC 60601-1-2:2014, 4th edition, to align the date with the recently announced EU harmonized standard date. Here’s a summary of upcoming FDA and EU effective dates.

Medical Electrical Equipment Standard

FDA effective date

EU effective date (DOCOPOCOSS)

Electromagnetic Disturbance, IEC 60601-1-2:2014 (ed 4)

31 Dec 2018

Announced 5 Jul 2016, extended from 1 Apr 2017,

31 Dec 2018, (EN 60601-1-2:2015)

Announced 13 May 2016

The scope of IEC 60601-1-2:2014, is safety, i.e. freedom from unacceptable risk.  During immunity testing, the medical electrical equipment under test must maintain basis safety and essential performance.  In some cases immunity levels are higher than currently specified in IEC 60601-1-2:2007.

The impact of transitioning

For a summary of the newer requirements in IEC 60601-1-2:2014, where new testing may be needed, see our prior news post here.

How Effective Dates Work

With FDA effective dates, these apply when seeking device clearance (510(k) or approval (PMA)). They don’t apply for products already cleared/approved for US market.

With EU effective dates, these apply to all products placed on EU market after date.

EM Compatibility

There's also a technical report, IEC TR 60601-4-2:2016, Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems. The scope of this technical report is EM compatibility. During immunity testing, the medical electrical equipment under test must maintain intended functionality. Immunity levels are a bit less than safety immunity levels. This technical report describes how to meet both EMC and EM Safety (IEC 60601-1-2) in one set of tests.

Other safety standard effective dates

For other related effective dates, see our prior news post here.

FDA EMC guidance

In a future post we'll describe FDA's 11 July 2016 EMC guidance document for manufactures seeking device approval.