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ISO 14971:2007

Medical devices -- Application of risk management to medical devices

General information

Withdrawn from 10.12.2019
ICS Groups
11.040.01 Medical equipment in general
Directives or regulations
None

Standard history

Status
Date
Type
Name
10.12.2019
Main
ISO 14971:2019
28.02.2007
Main
ISO 14971:2007
Main
ISO 14971:2000
Amendment
ISO 14971:2000/Amd 1:2003
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 associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

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Paper
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Standard monitoring
English (PDF 154 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English