Norm

NEN-EN-ISO 14971:2007 (Corr. 2012-07) en

Medische hulpmiddelen - Toepassing van risicomanagement voor medische hulpmiddelen (corrected and reprinted 2012-07)

179,33

Over deze norm

Status Definitief
Aantal pagina's 82
Commissie Medische hulpmiddelen - horizontale onderwerpen
Gepubliceerd op 01-03-2007
Taal Engels
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
Nederlandse titel Medische hulpmiddelen - Toepassing van risicomanagement voor medische hulpmiddelen (corrected and reprinted 2012-07)
Engelse titel Medical devices - Application of risk management to medical devices (corrected and reprinted 2012-07)
Vervangt
Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica

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