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I.S. EN ISO 14971:2007

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
Available format(s)

Hardcopy , PDF

Superseded date

10-10-2018

Language(s)

English

Published date

01-01-2007

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

This International Standard 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.

DocumentType
Standard
Pages
96
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

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US$141.42
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