ISO 14971:2007

Title

Language: EN Medical devices - Application of risk management to medical devices

Language: FR Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux

Abstract

Language: EN 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.

Language(s)
Language: EN
Edition
2.0
Date of issue
31.03.2007
TC 62/SC 62A
ICS Codes
11.040.01
Publication number
14971
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€ 180,00 (Download and hardcopy)
Delivery format
postal download (98 Pages)

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Mandatory Standard according current regulation Mandatory Standard according current regulation

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