IEC TR Edition INTERNATIONAL. STANDARD. Medical device software –. Part 3: Process reference model of medical device software. IEC/TR Edition TECHNICAL. REPORT. Medical device software –. Part 1: Guidance on the application of ISO to medical device. I want to know if IEC can be used for risk management our software or it is for medical products with software (not stand alone).
BS EN ISOrecognized worldwide by regulators, is widely acknowledged as the principal standard to use when performing medical device risk management. The content of these two standards provides the foundation for this technical report. Even though ISO 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 lec 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 iev, preventing harm or reducing its probability.
Software sequences of events which contribute to hazardous situations may fall into two categories:.
IEC/TR and ISO Medical Devices Software Package
A sequences of events representing unforeseen software responses to inputs errors in specification 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 idc 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 ic challenge and becomes even more challenging when software is involved. The following clauses contain additional details regarding 8002 specifics of software and provide guidance for understanding ISO Learn more about the cookies we use and how to change your settings.
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Guidance on ic application of ISO to medical device software Status: Click to learn more. 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. Areas already covered by existing or planned standards, e. Your basket is empty.
Take the smart route to manage medical device compliance. The faster, easier way to work with standards. Application of risk management to medical devices BS EN Symbols to be used with medical device labels, labelling, and ief to be supplied Symbol development, selection and validation.
PD IEC/TR 80002-1:2009
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