SIS-EN-ISO-14971 › Historical Revision Information
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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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.
To find similar documents by classification:
11.040.01 (Medical equipment in general)
Active implantable medical devices. Medical devices. In vitro diagnostic medical devices. 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
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Designation Name
SS-EN ISO 14971:2012
Revision Level
2012 EDITION
Status
Superseded
Publication Date
Aug. 29, 2012
Language(s)
English
Page Count
104
International Equivalent
EN ISO 14971:2012(IDT); ISO 14971:2007(IDT)