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).
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Please first log in with a verified email before subscribing to alerts. BS EN ISOrecognized worldwide by regulators, is widely acknowledged as the principal standard to use when performing medical device risk management. Proceed to Checkout Continue Shopping.
Establishing the safety and effectiveness lec 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. 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.
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You may find similar items within these categories by selecting from the choices below:. Symbols to be used with medical device labels, labelling, and information to be supplied Symbol development, selection and validation.
Complex software designs can permit complex sequences of events which may contribute to hazardous situations.
PD IEC/TR 80002-1:2009
Subscription pricing is determined by: Software should always be considered in a system perspective and software risk management cannot be performed in isolation from the system.
If the document is revised 8002 amended, you will be notified by email. You may delete a document from your Alert Profile at any time. The following clauses contain additional details regarding the specifics of software and provide guidance for understanding ISO The content of these two standards provides the foundation for this technical report. This standard is also available to be included in Standards Subscriptions. This package can be 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 sequences of events which contribute to hazardous situations may fall into two categories: Already Subscribed to this document. Risks arising from software anomalies need most often to 8002 evaluated on the severity of the harm alone.
Much of the task of software risk management consists of identifying those sequences of events that can lead to a 8000 situation and identifying points in the sequences of events at which the sequence can be interrupted, preventing harm or reducing its probability. Application of risk management to medical devices BS EN 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.
Standards Subsctiption may be the perfect solution. Life durabilityHazards, Electrical equipment, Computer technology, Equipment safety, Life cycle, Quality assurance systems, Software engineering techniques, Safety measures, Maintenance, Risk assessment, Medical equipment, Electrical medical equipment, Design, Quality management, Computer software.
IEC/TR and ISO Medical Devices Software Package
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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 iex aspects of risk analysis should be on identification of potential software functionality and anomalies that could result in hazardous situations — not on estimating probability.
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