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| Medical manufacturers live in a world where regulatory compliance must always be considered, including changes associated with IEC 60601. |
by Mark Leimbeck
Program Manager
UL EduNeering
Clarification of "Essential Performance"
When the 3rd Edition of IEC 60601 was published, two significant changes from the 2nd Edition were introduced: first, an expansion in the scope of the Standard from basic safety (only) to include essential performance; and second, introduction of a requirement for assessment of the risk management process applied by manufacturers in developing their medical devices.
The impact of these two changes was far-reaching, in that the concepts associated with mitigating basic safety risks (fire, electric shock and casualty) are well understood; however the concept of essential performance was new for many, and mitigating their risks even more of a challenge. Further complicating this situation was the fact that the 3rd Edition was the first attempt at including a requirement for performing an assessment of a process (in this case, the risk management process) in the context of a type examination test standard. As may have been anticipated given this background, Amendment 1 was largely focused on clarifying what the authors intended with respect to assessing the essential performance of a device, as well as how to assess a risk management process in the context of a type examination standard.