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ISO 14971:2007

Medical devices — Application of risk management to medical devices

95.99 Withdrawal of Standard   Dec 10, 2019

General information

95.99     Dec 10, 2019

ISO

ISO/TC 210

International Standard

11.040.01  

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

Revises
ISO 14971:2000

Revises
ISO 14971:2000/Amd 1:2003

NOW

WITHDRAWN
ISO 14971:2007
95.99 Withdrawal of Standard
Dec 10, 2019

REVISED BY

PUBLISHED
ISO 14971:2019

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