IEC 80002 PDF

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 the document is revised or amended, you will be notified by email. Areas already covered by existing or planned standards, e. 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.

This standard is also available to be included in Standards Subscriptions. As the voice of the U. A sequences of events representing unforeseen software responses to inputs errors in specification of the software. Software sequences of events which contribute to hazardous situations may fall into two categories:.

Accept and continue Learn more about the cookies we use and how to change your settings. Your basket is empty. Search all products by. The faster, easier way to work with standards. Subscription pricing is determined by: Please first log in with a verified email before subscribing to alerts. The content of these two standards provides the foundation for this technical report. Software sequences of events which contribute to hazardous situations may fall into two categories: Please download Chrome or Firefox or view our browser tips.

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Establishing the safety and effectiveness of a medical device containing software requires 800002 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. Take the smart route to manage medical device compliance.

PD IEC/TR 80002-1:2009

8002 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 should always be considered in a system perspective and software risk management cannot be performed in isolation from the system.

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Software is often an integral part of medical device technology. BS EN ISOrecognized worldwide by regulators, is widely acknowledged as the principal standard to use when performing medical device risk management. You may delete a document from your Alert Profile at any time.

Standards Subsctiption may be the perfect solution. Guidance on the application of ISO to medical device software Status: Risks arising from 08002 anomalies need most often to be evaluated on the severity of the harm alone. Symbols to be used with medical device labels, labelling, and information to be supplied Symbol development, selection and validation.

IEC/TR and ISO Medical Devices Software Package

Application of risk management to medical devices BS EN You may find similar items within these categories by selecting from the choices below:. 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. You may experience issues viewing this site in Internet Explorer 9, 10 or Standards Subscriptions from ANSI provides a money-saving, multi-user solution for accessing standards.

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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 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.

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.

Proceed to Checkout Continue Shopping. 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. Your Alert Profile lists the documents that will be monitored.

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This website is 880002 viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Complex software designs can permit complex sequences of events which may contribute to hazardous situations.

It includes ISO