IEC 60601-1 | Essential Performance | Clinical Function

IEC 60601-1 | Essential Performance | Clinical Function Explained

As for compliance to IEC 60601-1 3rd Ed, Amended

Manufacturer’s essential performance requirements differ based on the intended use of the device.

Essential Performance should be interpreted as “performance functions leading to unacceptable risks based on your risk analysis as part of your Risk Management.”

Clinical Function should be interpreted as “those features or functions suitable/necessary for the intended use of the device.  In other words, those features or functions required to render clinical benefits/utility/meaningfulness.  Collectively speaking, “effectiveness of the device.”

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