Back

IEC TR 80002-1:2009

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

General information
Valid from 23.09.2009
Directives or regulations
None
Standard history
Status
Date
Type
Name
23.09.2009
Main
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.
*
*
*
PDF
370.22 € incl tax
Paper
370.22 € incl tax
Standard monitoring
Customers who bought this item also bought
Main + amendment

EVS-EN 60601-1-2:2015+A1:2021

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014 + IEC 60601-1-2:2014/A1:2020)
Newest version Valid from 01.04.2021
Main + amendment

EVS-EN 60601-1-11:2015+A1:2021

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 + IEC 60601-1-11:2015/A1:2020)
Newest version Valid from 17.08.2021
Main + amendment

EVS-EN 60601-1-6:2010+A1+A2:2021

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010 + IEC 60601-1-6:2010/A1:2013 + IEC 60601-1-6:2010/A2:2020)
Newest version Valid from 17.08.2021
Main + amendment

EVS-EN 60601-1-8:2007+A1+A11+A2:2021

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8:2006 + IEC 60601-1-8:2006/A1:2012 + IEC 60601-1-8:2006/A2:2020)
Newest version Valid from 17.08.2021