Standard

ISO 14971:2007 ED2

Mar 2007 Revised

Note: Latest version: ISO 14971:2019 ED3

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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.

Products specifications

Standard from IEC
Published: March 31 2007
Withdrawn: February 18 2020
Edition: 2
Document type: IS
Pages
ISBN:

Publisher: IEC
Distributor: IEC
ICS: 11.040.01
International TC: TC 62/SC 62A

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Revised by: ISO 14971:2019 ED3
Revises: ISO 14971:2000 ED1

ISO 14971:2007 ED2

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ISO 14971:2019 ED3