CEI - UNI EN ISO 14971
Medical devices - Application of risk management to medical devices
inactive
| Organization: | CEI |
| Publication Date: | 1 October 2012 |
| Status: | inactive |
| Page Count: | 108 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
This International Standard 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 associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device.
This International Standard does not apply to clinical decision making.
This International Standard does not specify acceptable risk levels.
This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.
Document History
August 1, 2022
Medical devices - Application of risk management to medical devices
A description is not available for this item.
February 1, 2020
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...
UNI EN ISO 14971
October 1, 2012
Medical devices - Application of risk management to medical devices
This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and...
September 1, 2009
Medical devices - Application of risk management to medical devices
La presente Norma specifica la procedura che permette di identificare i pericoli associati ai dispositivi medici ed ai loro accessori, inclusi i dispositivi medico-diagnostici in vitro.
Essa permette...