DS/EN ISO 14971:2012 ( Withdrawn )

Medical devices - Application of risk management to medical devices


Status:
Withdrawn
Type:
Standard
Language:
Danish/English
Subject:
Replaced by:
Price from:
€ 151.81
Legislation:

Legislation

Harmonized under:
  • Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices

  • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

Scope

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.


Number of pages: 208

Published: 2013-02-08

Date of approval: 2012-12-21

Date of withdrawal: 2020-06-30

International relationships : EN ISO 14971:2012 IDT ISO 14971:2007 IDT

ICS: 11.040.01 - Medical equipment in general 11.120.01 - Pharmaceutics in general

Item number: M268419


Committees

Committee

  • CENCLC/JTC 3
  • ISO/TC 210/JWG 1

Danish committee

DS/S-257