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.
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