EMC Testing for Medical Electrical Equipment: IEC 60601-1-2:2014

IEC 60601-1-2 for Medical Electrical Equipment

IEC 60601-1-2 is the primary EMC standard for medical electrical devices and systems, and is titled “Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Test.”

The IEC 60601-1-2 committee released a revised version of this standard in 2014 (Edition 4) to replace the previous version from 2007 (Edition 3.)
In this article, we detail the differences between these versions as well as provide information about the implementation dates in the US (FDA) and EU (European Union).

Environments

Environments of Intended Use are now identified as:

• Professional Healthcare Facility
• Home Healthcare (and small clinic)
• Special

In the standard there are good descriptions of what is considered part of these environments and there is no distinction between life support and non-life support, as previously called out in the 2007 version.

Equipment Under Test (EUT) AC line voltage

In previous versions of this EMC standard, multiple Equipment Under Test AC line voltages were called out to be tested for many of the tests to be run. The 2014 version of IEC 60601-1-2 requires only one nominal AC power line voltage and frequency for each test, with the exception of Voltage Dips and Interruptions (VDI) which calls for a minimum and maximum rated voltage.

Test Plan and Risk Management

Prior to the start of formal testing, a detailed test plan shall be provided to the test laboratory.

Deviations from the test plan shall be documented in the test report. Guidance on the recommended content of a test plan is detailed in Annex G of IEC 60601-1-2:2014. This should detail the risk management approach and the basic safety and essential performance required for the EUT.

IEC 60601-1-2 Implementation Dates

United States (FDA) – As of 17 October 2014, the FDA included IEC 60601-1-2 Edition 4: 2014-02 on their list of Recognized Consensus Standards.  

According to the FDA, they will accept declarations of conformity (DoC) in support of pre-market submissions, for the IEC 60601-1-2 Edition 3:2007-03 or the Edition 4:2014-02 standards until 31 December 2018.  After that date, they will only recognize DoCs which show testing according to the IEC 60601-1-2 Edition 4:2014-02 standard.

European Union (EU) – the latest edition is now listed in the EU Official Journal as EN 60601-1-2:2015, but is the technical equivalent of IEC 60601-1-2:2014. The Date of Cessation of presumption of conformity of the superseded standard is 31 December 2018.  The 2007 version can be used until that date, and then after that date only the latest version can be used.

Below is a comparison table of the test requirements. Key changes are in bold

Element provides a wide range of testing and certification services to ensure that you meet the necessary IEC 60601 series of standards product safety requirements recognized across the world. 

For more information about our IEC 60601 Medical Device Safety Testing services, or to request a quote, contact us today.