The IEC 60601 standards series is one part of putting together a technical file or a 510(k) submission. It’s about more than electrical safety — it covers mechanical safety, labeling and risk ...

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.

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 ...

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 ...

IEC 60601 is no longer a standard of absolutes. The third edition allows, and in some instances requires, safety features and test requirements to be modified on the basis of risk management. By ...

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 ...

Overview: In this presentation we will review the certification requirements for documentation of the clauses of IEC 60601-1 Third Edition. The purpose will be to provide medical device manufacturers ...

Linear Technology has introduced the LTM2885, an isolated RS485 µModule transceiver for guarding against large ground-to-ground differentials. The LTM2885 provides 6500V rms reinforced isolation ...

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 ...

CUI Devices has announced a line of medical buzzers compliant with IEC 60601-1-8 alarm signal requirements. There are four CPIM-4410-80x buzzers, with a letter replacing the ‘x’ depending on function: ...