Standard

ISO 14971:2007

Feb 2007 Withdrawn

Note: Latest version: ISO 14971:2019

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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.

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Standard from ISO
Published: February 28 2007
Withdrawn: December 10 2019
Period for objection until: February 10 2006
Edition: 2
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.040.01
International TC: ISO/TC 210

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Revised by: ISO 14971:2019
Adopted by: NF EN ISO 14971:2013
Adopted by: SN EN ISO 14971:2012
Adopted by: SN EN ISO 14971:2010
Adopted by: NF EN ISO 14971:2009
Adopted by: SN EN ISO 14971:2007
Adopted by: NF EN ISO 14971:2007
Revises: ISO 14971:2000

ISO 14971:2007

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ISO 14971:2019

ISO 14971:2007

ISO 14971:2000

Abstract

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Version history History (3)

ISO 14971:2019

ISO 14971:2007

ISO 14971:2000

Abstract

Products specifications

Product Relations

Product life cycle