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Reference IEC/TR 80002-1 ed1.0 withdrawn corrigendum
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Title Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
Publication date 2009-09-23
Format, price
(Swiss francs)
and language
280.- 64 pages
280.- 1313 Kb
 
Abstract IEC/TR 80002-1:2009(E) provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices - Application of risk management to medical devices to medical device software with reference to IEC 62304:2006, Medical device software - Software life cycle processes. It does not add to, or otherwise change, the requirements of ISO 14971:2007 or IEC 62304:2006. IEC/TR 80002-1:2009(E) is aimed at risk management practitioners who need to perform risk management when software is included in the medical device/system, and at software engineers who need to understand how to fulfil the requirements for risk management addressed in ISO 14971. ISO 14971, recognized worldwide by regulators, is widely acknowledged as the principal standard to use when performing medical device risk management. IEC 62304:2006, makes a normative reference to ISO 14971 requiring its use. The content of these two standards provides the foundation for this technical report. It should be noted that even though ISO 14971 and this technical report focus on medical devices, this technical report may 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. IEC/TR 80002-1:2009 is not intended to be used as the basis of regulatory inspection or certification assessment activities.
Technical Committee 62A - Common aspects of electrical equipment used in medical practice  RSS
ICS Codes
11.040.01 Medical equipment in general
 
Replaced by
Stability date 2015
 
Work in progress
ProjectStage codeForecast publication date
No project under development--


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