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S.R. CEN ISO/TR 24971:2020

Current
Current

The latest, up-to-date edition.

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-10-2020

Preview

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for risk management system
5 Risk analysis
6 Risk evaluation
7 Risk control
8 Evaluation of overall residual risk
9 Risk management review
10 Production and post-production activities
Annex A (informative) Identification of hazards and characteristics related to safety
Annex B (informative) Techniques that support risk analysis
Annex C (informative) Relation between the policy, criteria for risk acceptability, risk control and risk evaluation
Annex D (informative) Information for safety and information on residual risk
Annex E (informative) Role of international standards in risk management
Annex F (informative) Guidance on risks related to security
Annex G (informative) Components and devices designed without using ISO 14971
Annex H (informative) Guidance for in vitro diagnostic medical devices
Bibliography

This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.

Committee
TC 103
DocumentType
Standard Recommendation
Pages
104
ProductNote
The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS TO :AAMI TIR 57:2016
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
CEN ISO/TR 24971:2020 Identical
ISO/TR 24971:2020 Identical

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