Standard

NS-EN ISO 14971:2007

Jul 2007 Withdrawn

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

Corrigendums and amendments are bought separately.

Language English Norwegian

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

Document information

Standard from SN
Published: 1 July 2007
Withdrawn: 1 October 2009
Edition: 2007-03
Version: 1
Document type: NAT
ISBN:

ICS 11.040.01
National Committee SN/K 113

Product Relations

Replaces: NS-EN ISO 14971:2009
Replaced by: NS-EN ISO 14971:2009
Replaces: NS-EN ISO 14971:2001
Adopted from: EN ISO 14971:2007 , 0

NS-EN ISO 14971:2007

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NS-EN ISO 14971:2019

NS-EN ISO 14971:2012

NS-EN ISO 14971:2009