S.R. CEN ISO/TR 24971:2020
Current
The latest, up-to-date edition.
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
Hardcopy , PDF
English
10-08-2020
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 |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| ISO 14155:2020 | Clinical investigation of medical devices for human subjects — Good clinical practice |
| ISO 20776-2:2007 | Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2: Evaluation of performance of antimicrobial susceptibility test devices |
| ISO/TS 17822-1:2014 | In vitro diagnostic test systems — Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens — Part 1: General requirements, terms and definitions |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 11608-1:2014 | Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems |
| IEC 62366-1:2015 | Medical devices - Part 1: Application of usability engineering to medical devices |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 17511:2020 | In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples |
| ISO 10993-1:2018 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 22367:2020 | Medical laboratories — Application of risk management to medical laboratories |
| ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| IEC 61882:2016 | Hazard and operability studies (HAZOP studies) - Application guide |
| ISO 18113-5:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing |
| ISO 15197:2013 | In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
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