IEC - International Electrotechnical Commission - ISO 14971:2019
Medical devices - Application of risk management to medical devices
published
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Organization: | IEC - International Electrotechnical Commission |
Publication Date: | 10 December 2019 |
Status: | published |
Page Count: | 36 |
ICS Code (Medical equipment in general): | 11.040.01 |
abstract:
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process... View More
Document History

ISO 14971:2019
December 10, 2019
Medical devices - Application of risk management to medical devices
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...

March 31, 2007
Medical devices - Application of risk management to medical devices
ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the...

March 31, 2003
Amendment 1 - Medical devices - Application of risk management to medical devices
A description is not available for this item.

December 31, 2000
Medical devices - Risk management - Application of risk management to medical devices
A description is not available for this item.