Standard

NS-EN ISO 14971:2012

Oct 2012 Withdrawn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

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.

Document information

Standard from SN
Published: 1 October 2012
Withdrawn: 1 March 2020
Edition: 2012-07
Version: 1
Document type: NAT
Pages
ISBN:

ICS 11.040.01
National Committee SN/K 113

Legal references

EU law:

Law reference	Restrictions
90/385/EEC
2007/47/EC
93/42/EEC
98/79/EC

Product Relations

Replaced by: NS-EN ISO 14971:2019
Joinded work item: NEK EN ISO 14971:2012
Replaces: NS-EN ISO 14971:2009
Adopted from: EN ISO 14971:2012, 0

NS-EN ISO 14971:2012

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NS-EN ISO 14971:2019