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ISO 14971:2007 ED2

Medical devices - Application of risk management to medical devices

Mar 31, 2007

General information

99.60     Feb 18, 2020

IEC

TC 62/SC 62A

International Standard

11.040.01  

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Revised

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 14971:2000 ED1

WITHDRAWN
ISO 14971:2000/AMD1:2003 ED1

NOW

WITHDRAWN
ISO 14971:2007 ED2
99.60 Withdrawal effective
Feb 18, 2020

REVISED BY

PUBLISHED
ISO 14971:2019 ED3