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 ...

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.

Although the transition period for the third edition of the medical electrical equipment standard (IEC 60601-1:2005) doesn’t end until 2012, there are many changes and firsts that design engineers ...

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 ...

‘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 ...

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 ...

Standards are an integral part of product design and development, and are vitally important in medical applications. With the recent transition to IEC 60601-1 3rd edition, designers of medical ...

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 ...