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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If lec document is revised or amended, you will be notified by email. Need more than one copy? Click to learn more. Software should always be considered in a system perspective and software risk management cannot be performed in isolation from the system.
Software sequences of events which contribute to hazardous situations may fall 8002 two categories:. Software sequences of events which contribute to hazardous situations may fall into two categories: Symbols to be used with medical device labels, labelling, and information to be supplied Symbol development, selection and validation.
Software is often an integral part of medical device technology. It includes ISO 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.
As the voice of the U. 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 08002 itself a hazard, but software may contribute to hazardous situations.
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BS EN ISOrecognized worldwide by regulators, is widely acknowledged as the principal standard to use when performing medical device risk management. A sequences of events representing unforeseen software responses to inputs errors in specification of the software. You may delete a document from your Alert Profile at any time. This package can be to implement a safety risk management iecc for all software in the ieec environment independent of whether it is classified as a medical device.
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PD IEC/TR 80002-1:2009
IEC/TR and ISO Medical Devices Software Package
Guidance on the application of ISO to medical device software Status: You can download and open this file to your own computer but DRM prevents opening this file on another computer, including a networked server.
The following clauses contain additional details regarding the specifics of software and provide guidance for understanding ISO Complex software designs can permit complex sequences of events which may contribute to hazardous situations.
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You may experience issues idc this site in Internet Explorer 9, 10 or The faster, easier way to work with standards. The content of these two standards provides the foundation for this technical report. 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 iecc software in the healthcare environment independent of whether it is classified as a medical device.
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Already Subscribed to this document. Please download Chrome or Firefox or view our browser iex. 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.