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Standard

NS-EN ISO 14971:2009

Withdrawn

Note: This standard has a new edition: NS-EN ISO 14971:2019

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Abstract

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 place. However, risk management can be an integral part of a quality management system.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 2009-07
  • Version: 1
  • Document type: NAT
  • Pages
  • ICS 11.040.01
  • National Committee SN/K 113

Legal references

EU law:
Law referenceRestrictions
90/385/EEC
93/42/EEC
2007/47/EC
98/79/EC

Product Relations

Product life cycle