The third edition of IEC 60601-1 was published in December 2005, but few certification bodies (CB) certificates have actually been issued to this version of the standard and few agency mark projects ...

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 ...

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 ...

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 ...

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 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: ...