The Era of a New Edition: A Closer Look at IEC 60601-1

28 Feb 2011

The medical device industry continues to experience an increase in regulation and patient/provider safety use guidelines. But why? Over the last two decades, medical devices have evolved to – essentially – do more with less. Translation: As technology has continued to evolve, this evolution has created new, innovative ways for such medical devices to be deployed. Hence, this leads to a demand for a new approach developing standards.

More than two decades ago, the medical device industry went through the Second Edition. But in 2005, that Edition transformed itself into what is now formally referred to today as the Third Edition of IEC 60601-1. What are the fundamental changes of the Third Edition to this new standard and who is directly affected?

Many companies are aware that the third edition of IEC 60601-1 will have some impact on them, but they might not be clear to what extent. The impact will not only include manufacturers of medical devices, but also organizations that certify this standard to ensure safety regulations. And what about any structural changes to this Third Edition of the standard?

As noted, technology's impact over the last 10 – 15 years has changed the way medical devices are being used. The Third Edition takes into account this impact.

So, where does that leave the new requirements for risk management? Learn more about Third Edition and risk management in the March 14 blog.

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