S.R. CEN ISO/TR 24971:2020
Current
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
Hardcopy , PDF
English
08-10-2020
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 |
ISO/TC 210
|
| 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 |
| UNE-CEN ISO/TR 24971:2020 | Equivalent |
| PD CEN ISO/TR 24971:2020 | Equivalent |
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