Standard

NEK EN ISO 14971:2012

Jul 2012 Withdrawn

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

Corrigendums and amendments are bought separately.

Language English

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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 NEK
Published: 6 July 2012
Withdrawn: 18 December 2019
Edition: 2012-07
Version: 1
Document type: NAT
Pages
ISBN:

ICS 11.040.01
National Committee CEN/CLC/JTC 3

Legal references

EU law:

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

Product Relations

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

NEK EN ISO 14971:2012

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NEK EN ISO 14971:2019