ISO 14971:2007

Name: ISO 14971:2007
Brand: ISO
SKU: ISO 14971:2007
Price: 76.23 EUR
Availability: InStock
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Medical devices — Application of risk management to medical devices

Publication date: Feb 28, 2007

95.99 Withdrawal of Standard Dec 10, 2019

General information

Current stage: 95.99 Withdrawal of Standard Dec 10, 2019

Originator: ISO

Owner: ISO/TC 210 Quality management and corresponding general aspects for medical devices

Type: International Standard

ICS: 11.040.01 Medical equipment in general

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Status: Withdrawn

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Languages: English French Russian

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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WITHDRAWN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

WITHDRAWN
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WITHDRAWN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