Software validation: requirements for programmable electronic medical systems, how to comply with the essential...

In the second part of this two-part article, the author reviews existing standards and current international and European standardization work, which serves to highlight the need for harmonized standards for medical devices that incorporate software. The new concepts of essential performance, and safety integrity, severity, and risk levels are examined, and these present a new basis for the revision of safety standards to make them relevant to the EC Directives.