MEDICAL

Introduction to IEC 62304:2006

IEC 62304:2006, “Medical device software — Software life cycle processes,” is an international standard issued by IEC. It has been followed, in 2015, by IEC 62304:2006/Amd 1:2015, which added requirements to deal with legacy software and updated the software safety classification to include a risk-based approach. IEC62304 defines the life cycle requirements, including development and maintenance, for medical device software. The required processes, tasks, and activities are dependent on whether and how the device software can contribute to an hazardous situation: this takes into account the risk for the patients, the caregivers, the property, and the environment. Software systems are partitioned into three safety classes:

Class A:
the software system cannot contribute to a hazardous situation, OR, the software system can contribute to a hazardous situation which does not result in unacceptable risk after consideration of risk control measures external to the software system;
Class B:
the software system can contribute to a hazardous situation which results in unacceptable risk after consideration of risk control measures external to the software system and the resulting possible harm is non-serious injury;
Class C:
the software system can contribute to a hazardous situation which results in unacceptable risk after consideration of risk control measures external to the software system and the resulting possible harm is death or serious injury.

Role of ECLAIR in Ensuring Compliance with IEC 61508:2010

The ECLAIR Software Verification Platform can be used to comply with several of the requirements of IEC 62304. In addition, the ECLAIR Fusa Pack greatly simplifies obtaining all the confidencebuilding evidence that is required to make a solid argument justifying the use of ECLAIR in safetyrelated projects.

 

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