99.60 Withdrawal effective Dec 18, 2019
CEN/CENELEC
CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices
European Norm
11.040.01 Medical equipment in general
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.
Legislation related to this standard
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
WITHDRAWN
EN ISO 14971:2009
WITHDRAWN
EN ISO 14971:2012
99.60
Withdrawal effective
Dec 18, 2019
PUBLISHED
EN ISO 14971:2019