Medical device software - Guidance on the application of ISO 14971 to medical device software
Medical device software - Guidance on the application of ISO 14971 to medical device software
PD IEC/TR 80002-1-1:2009 Medical device software. Guidance on the application of ISO 14971 to medical device software PD IEC/TR 80002-1-1 is a technical report aimed at risk management practitioners who need to perform risk management when software is included in the medical device/system, and at software engineers who need to understand how to fulfil the requirements for risk management addressed in ISO 14971 . BS EN ISO 14971 , recognized worldwide by regulators, is widely acknowledged as the principal standard to use when performing medical device risk management. IEC 62304 makes a normative reference to ISO 14971 requiring its use. The content of these two standards provides the foundation for this technical report. Even though ISO 14971 and this technical report focus on medical devices, this technical report could also be used to implement a safety risk management process for all software in the healthcare environment independent of whether it is classified as a medical device. Software is often an integral part of medical device technology. Establishing the safety and effectiveness of a medical device containing software requires knowledge of what the software is intended to do and demonstration that the implementation of the software fulfils those intentions without causing any unacceptable risks. It is important to understand that software is not itself a hazard, but software may contribute to hazardous situations. Software should always be considered in a system perspective and software risk management cannot be performed in isolation from the system. Complex software designs can permit complex sequences of events which may contribute to hazardous situations. Much of the task of software risk management consists of identifying those sequences of events that can lead to a hazardous situation and identifying point...
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