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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Take the smart route to manage medical device compliance.
PD IEC/TR 80002-1:2009
Your Alert Profile lists the documents that will be monitored. Software sequences of events which contribute to hazardous situations may fall into two categories: Click to learn more. Software is often an integral part of medical device technology.
The following clauses contain additional details regarding the specifics of software and provide guidance for understanding ISO If the document is revised or amended, you will be notified by email. Application of risk management to medical devices BS EN The faster, easier way to work with standards.
Even though ISO and this 800002 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. Search all products by. Please first verify your email before subscribing to alerts. Learn more about the cookies we use and how to change your settings. This website is best ifc with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.
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 iex risks.
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Standards Subsctiption may be the perfect solution. These categories are specific to software, arising from the difficulty of correctly specifying and implementing a complex irc and the difficulty of completely verifying a complex system.
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. Life durabilityHazards, Electrical equipment, Computer technology, Equipment safety, Life cycle, Quality assurance systems, Software engineering 800002, Safety measures, 8002, Risk assessment, Medical equipment, Electrical medical equipment, Design, Quality management, Computer software.
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.
Software sequences of events which contribute to hazardous situations may fall into two categories:.
IEC/TR and ISO Medical Devices Software Package
It is important to understand that software is not itself a hazard, but software may contribute to hazardous situations. You may experience issues viewing this site in Internet Explorer 9, 10 or Complex software designs can permit complex sequences of events which may contribute to hazardous situations. A sequences of events representing unforeseen software responses to inputs errors in specification of the software.
Risk management is always a challenge and becomes even more challenging when software is involved.
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