Skip to main content
Back

EVS-EN ISO 14971:2012

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

General information

Withdrawn from 02.01.2020
Base Documents
ISO 14971:2007; EN ISO 14971:2012
Directives or regulations
None

Standard history

Status
Date
Type
Name
02.01.2020
Main
05.12.2012
Main
Main
EVS-EN ISO 14971:2009
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.

Required fields are indicated with *

*
*
*
PDF
39.04 € incl tax
Paper
39.04 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main + corrigendum

EVS-EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Valid from 02.03.2016
Main

EVS-EN 62366-1:2015

Medical devices - Part 1: Application of usability engineering to medical devices
Valid from 07.05.2015
Amendment

EVS-EN 62304:2006/A1:2015

Medical device software - Software life-cycle processes
Valid from 04.11.2015
Main

EVS-EN ISO 15223-1:2016

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
Withdrawn from 01.10.2021