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 |
| UNE-CEN ISO/TR 24971:2020 | Equivalent |
| PD CEN ISO/TR 24971:2020 | Equivalent |
| IEC 61025:2006 | Fault tree analysis (FTA) |
| 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 |
| IEC 61326-2-6:2012 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
| 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/IEC Guide 63:2019 | Guide to the development and inclusion of aspects of safety in International Standards for medical devices |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| ISO 11608-1:2014 | Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems |
| IEC 60601-2-16:1998 | Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment |
| IEC 60812:1985 | Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
| IEC GUIDE 120:2018 | Security aspects - Guidelines for their inclusion in publications |
| IEC 62366-1:2015 | Medical devices - Part 1: Application of usability engineering to medical devices |
| IEC 62502:2010 | Analysis techniques for dependability - Event tree analysis (ETA) |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 20916:2019 | In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice |
| ISO 17511:2020 | In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples |
| IEC 60601-1:1988 | Medical electrical equipment - Part 1: General requirements for safety |
| ISO 10993-1:2018 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| IEC 60601-1-8:2003 | Medical electrical equipment - Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| IEC TR 62366-2:2016 | Medical devices - Part 2: Guidance on the application of usability engineering to medical devices |
| ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| 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 60601-1-2:2001 | Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| IEC 61882:2016 | Hazard and operability studies (HAZOP studies) - Application guide |
| IEC 61010-2-101:2015 | Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
| 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 |
| ISO/TR 20416:2020 | Medical devices — Post-market surveillance for manufacturers |
| IEC TR 60601-4-1:2017 | Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy |
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