Standard

NEN-EN-ISO 14971:2007 en

Medical devices - Application of risk management to medical devices

  • This norm is withdrawn since 01-08-2009

198,82 216,71 Incl BTW

About norm

Status Withdrawn
Number of pages 82
Committee Medische hulpmiddelen - horizontale onderwerpen
Published on 01-03-2007
Language English
This International Standard 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 this International Standard are applicable to all stages of the life-cycle of a medical device. This International Standard does not apply to clinical decision making. This International Standard does not specify acceptable risk levels. This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.

Details

ICS-code 11.040.01
Dutch title Medische hulpmiddelen - Toepassing van risicomanagement voor medische hulpmiddelen
English title Medical devices - Application of risk management to medical devices
Replaces
Replaced by

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