UPDATE: On 13 July 2012 IEC formally published the long awaited IEC 60601-1:05 (also known as third edition) Amendment 1 (A1). It is on the IEC.ch website’s store. See below for more detail about A1.

Does your company develop electronic medical devices? IEC 60601 is different from other regulatory compliance processes and can be challenging for medical device developers in this category. You’ll ...

Earlier this year the US followed the EU and Canada in moving to the3 rd edition of the IEC 60601-1 medical device standard. This change presents several challenges and adds layers of complexity for ...

An expert discusses what medical device manufacturers need to keep in mind as the compliance date for the fourth edition of the IEC 60601-1-2 standard approaches. Manufacturers developing and ...

On August 5, 2013, the U.S. FDA announced the extension of the transition date for IEC 60601-1 3rd edition from June 30, 2013 to December 31, 2013. This means the FDA will accept pre-market ...

Risks to a medical device’s performance can occur at any stage of the product lifecycle, as highlighted at the 2015 Risk Management Summit conducted by AAMI. Sometimes, changes in a product may be so ...

The upcoming 4th Edition of the IEC 60601 1 standard represents a significant evolution in the regulatory expectations for medical electrical equipment and medical electrical systems. This ...

‘IEC 60601-2-25 ED. 2.0 B:2011 - Medical electrical equipment - Part 2-25: Particular Requirements for the Basic Safety and Essential Performance of Electrocardiographs’ outlines a standard protocol ...

CUI Devices’ Audio Group has announced a new line of medical buzzers compliant with the alarm signal requirements of IEC 60601-1-8. The CPIM family is a range of piezo audio indicator buzzers capable ...