Standard

ISO 14971:2007 ED2

Mar 2007 Revised

Note: This standard has a new edition: ISO 14971:2019 ED3

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 IEC
Published: 31 March 2007
Withdrawn: 18 February 2020
Edition: 2
Version: 1
Document type: IS
Pages
ISBN:

ICS 11.040.01
ISO TC TC 62/SC 62A

Product Relations

Revised by: ISO 14971:2019 ED3
Amends: NEK CISPR 16-1-1:2006
Revises: ISO 14971:2000 ED1

ISO 14971:2007 ED2

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ISO 14971:2019 ED3