A Closer Look: Risk Management and IEC 60601-1

14 Mar 2011

Third Edition IEC 60601-1 has a continued impact on manufacturers of medical devices. Specifically, this standard is different from the second edition in that it now adds a risk management factor that all manufacturers and certifying bodies must comply. But what does this really mean?

There is an increased element of risk management in this standard because it is strategically integrated throughout its entirety. Manufacturers now have to implement a risk management process and recognize ways to determine risk acceptance in accordance with ISO 14971. However, there still remains some flexibility to these new risk management standards. But where and how does this flexibility work?

Third Edition IEC 60601-1 clause 4.5 allows for an equivalent means of safety if risk management shows zero hazards from not meeting the applicable clause of the standard. Translation: Risk management can now be used to design a standard the specific device must meet.

Both clause 4.2 and clause 4.5 of Third Edition IED 60601-1 are essential to understanding how risk management can and needs to be applied with this standard.

To learn more about Third Edition and risk management or to speak with an Intertek expert on this subject matter, e-mail us at ThirdEdition@intertek.com