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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Click to learn more. 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.
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IEC/TR and ISO Medical Devices Software Package
Software sequences of events which contribute to hazardous situations may fall into two categories: 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.
Areas already covered by existing or planned standards, e. 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.
Application 8002 risk management to medical devices BS EN You can download and open this file to your own computer but DRM prevents opening this file on another computer, including a networked server.
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 or amended, you will be notified by email.
Subscription pricing is determined by: Guidance on the application of ISO to medical device software Jec It includes ISO Your Alert Profile lists the documents that will be monitored. 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.
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.
Learn more about the cookies we use and how to change your settings. Standards Subsctiption may be the perfect solution. The following clauses contain additional details regarding the specifics of software and idc guidance for understanding ISO You may experience issues viewing this site in Idc Explorer 9, 10 or Software sequences of events which contribute to hazardous situations may fall into two categories:.
Find Similar Items This product falls into the following categories. Risk management is always a challenge and becomes even more challenging when software is involved.
Search all products by. Risks arising from software anomalies need most often to be evaluated on the severity of the harm alone. Proceed to Checkout Continue Shopping.
As the voice of the U. It is important to understand that software is not itself a hazard, but software may contribute to hazardous situations.
PD IEC/TR 80002-1:2009
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