IEC 60601-1-2:2014 4th Edition

TRaC Global Ltd is pleased to announce we now have UKAS accreditation to IEC 60601-1-2:2014. This means our clients can achieve Food and Drug Administration (FDA) listing and ready access to the US market.

From 1st April 2017 the FDA will no longer recognise the IEC 3rd edition EMC standard, IEC 60601-1-2:2007. We can assist manufacturers and ensure their medical electrical equipment complies with the 4th edition - IEC 60601-1-2:2014 by this date.

We understand how financially important it is for manufacturer’s to future-proof, as far as is possible, testing strategies. We have four key facts to assist you with the standard update:

1)     If manufacturers want to sell their new medical products in North America and other markets they need a 4th Edition EMC report

2)     All existing medical products in North America need to meet the 4th Edition before 1st April 2017

3)     The standard will eventually be harmonised in the EU, however manufacturers can avoid testing twice (3rd edition now and 4th later) by looking to use the 4th Edition now

4)     Using the new standard gives manufacturers a technical advantage over others who are still using the 3rd edition and enables them to demonstrate more modern compliance.

The requirements of the 4th edition do vary a lot from the 3rd edition. For example ESD air discharge has been increased from 8kV to 15kV and modulation frequencies and dwell times are now defined by risk assessment and the test plan.  Standard updates can be daunting but we can help and ensure you avoid costly delays or retesting.

To learn more about the 4th edition - IEC 60601-1-2:2014 and to see how we can help you, email your specification and requirements to quoteme@tracglobal.com, enter your details into the blue form or call us on the number in the top right hand corner of this page.

 

August 2015