ISO TR 24971:2013

Medical devices -- Guidance on the application of ISO 14971

ISO TR 24971:2013 provides guidance in addressing specific areas of ISO 14971 when implementing risk management. This guidance is intended to assist manufacturers and other users of the standard to understand the role of international product safety and process standards in risk management, develop the policy for determining the criteria for risk acceptability, incorporate production and post-production feedback loop into risk management, differentiate between "information for safety" and "disclosure of residual risk", and evaluate overall residual risk.

General Information

• Status: Published
• Publication Date: 18-Jun-2013
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• ICS: 29.035.50 - Mica based materials
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: JWG 1 - TC 62/SC 62A/JWG 1
• Current Stage: DELPUB - Deleted Publication
• Start Date: 24-Nov-2017
• Completion Date: 19-Jun-2020

Relations

• Revised: ISO TR 24971:2020 - Medical devices - Guidance on the application of ISO 14971
• Effective Date: 05-Sep-2023

Standards Content (Sample)

TECHNICAL ISO/TR
REPORT 24971
First edition
2013-07-01
Medical devices — Guidance on the
application of ISO 14971
Dispositifs médicaux — Directives relatives à l’ISO 14971
Reference number
ISO/TR 24971:2013(E)
©
ISO 2013

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ISO/TR 24971:2013(E)

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© ISO 2013
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ii © ISO 2013 – All rights reserved

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ISO/TR 24971:2013(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 The role of international product safety and process standards in risk management .1
2.1 Overview . 1
2.2 Use of international product safety standards in risk management . 2
2.3 International process standards and ISO 14971 . 4
3 Developing the policy for determining the criteria for risk acceptability .6
4 Production and post-production feedback loop . 6
4.1 Overview . 6
4.2 Observation and transmission . 7
4.3 Assessment . 9
4.4 Action . 9
5 Differentiation of information for safety and disclosure of residual risk .10
5.1 Difference between “information for safety” and “disclosure of residual risk” .10
5.2 Information for safety .10
5.3 Disclosure of residual risk .10
6 Evaluation of overall residual risk .11
6.1 Overview .11
6.2 Inputs and other considerations for overall residual risk evaluation .11
© ISO 2013 – All rights reserved iii

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ISO/TR 24971:2013(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member bod
...