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 points in the sequences of events at which the sequence can be interrupted, preventing harm or reducing its probability.
Software sequences of events which contribute to hazardous situations may fall into two categories:
A) sequences of events representing unforeseen software responses to inputs (errors in specification of the software)
B) sequences of events arising from incorrect coding (errors in implementation of the software).
These categories are specific to software, arising from the difficulty of correctly specifying and implementing a complex system and the difficulty of completely verifying a complex system.
Since it is very difficult to estimate the probability of software anomalies that could contribute to hazardous situations, and since software does not fail randomly in use due to wear and tear, the focus of software aspects of risk analysis should be on identification of potential software functionality and anomalies that could result in hazardous situations – not on estimating probability. Risks arising from software anomalies need most often to be evaluated on the severity of the harm alone.
Risk management is always a challenge and becomes even more challenging when software is involved. The following clauses contain additional details regarding the specifics of software and provide guidance for understanding ISO 14971:2007 in a software perspective. of risk management activities in the software life-cycle.
This part of PD IEC/TR 80002 does not address:
PD IEC/TR 80002-1-1 is not intended to be used as the basis of regulatory inspection or certification assessment activities.
IEC TR 80002-1:2009