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.
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Section sec_1
Section sec_2
Section sec_2.1
Section sec_2.2
Figure fig_1
Section sec_2.3
Section sec_3
Section sec_4
Section sec_4.1
Section sec_4.2
Figure fig_2
Section sec_4.3
Section sec_4.4
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.3
Section sec_6
Section sec_6.1
Section sec_6.2
Foreword
Introduction
1 Scope
2 The role of international product safety and process standards in risk management
2.1 Overview
2.2 Use of international product safety standards in risk management
2.3 International process standards and ISO 14971
3 Developing the policy for determining the criteria for risk acceptability
4 Production and post-production feedback loop
4.1 Overview
4.2 Observation and transmission
4.3 Assessment
4.4 Action
5 Differentiation of information for safety and disclosure of residual risk
5.1 Difference between “information for safety” and “disclosure of residual risk”
5.2 Information for safety
5.3 Disclosure of residual risk
6 Evaluation of overall residual risk
6.1 Overview
6.2 Inputs and other considerations for overall residual risk evaluation
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Section sec_1
Section sec_2
Section sec_2.1
Section sec_2.2
Figure fig_1
Section sec_2.3
Section sec_3
Section sec_4
Section sec_4.1
Section sec_4.2
Figure fig_2
Section sec_4.3
Section sec_4.4
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.3
Section sec_6
Section sec_6.1
Section sec_6.2
Foreword
Introduction
1 Scope
2 The role of international product safety and process standards in risk management
2.1 Overview
2.2 Use of international product safety standards in risk management
2.3 International process standards and ISO 14971
3 Developing the policy for determining the criteria for risk acceptability
4 Production and post-production feedback loop
4.1 Overview
4.2 Observation and transmission
4.3 Assessment
4.4 Action
5 Differentiation of information for safety and disclosure of residual risk
5.1 Difference between “information for safety” and “disclosure of residual risk”
5.2 Information for safety
5.3 Disclosure of residual risk
6 Evaluation of overall residual risk
6.1 Overview
6.2 Inputs and other considerations for overall residual risk evaluation