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CSA ISO 14971 : 2007 : R2017

Current
Current

The latest, up-to-date edition.

MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

Foreword
Introduction
1 Scope
2 Terms and definitions
3 General requirements for risk management
4 Risk analysis
5 Risk evaluation
6 Risk control
7 Evaluation of overall residual risk acceptability
8 Risk management report
9 Production and post-production information
Annex A (informative) - Rationale for requirements
Annex B (informative) - Overview of the risk management process
        for medical devices
Annex C (informative) - Questions that can be used to identify
        medical device characteristics that could impact on safety
Annex D (informative) - Risk concepts applied to medical devices
Annex E (informative) - Examples of hazards, foreseeable sequences
        of events and hazardous situations
Annex F (informative) - Risk management plan
Annex G (informative) - Information on risk management techniques
Annex H (informative) - Guidance on risk management for in vitro
        diagnostic medical devices
Annex I (informative) - Guidance on risk analysis process for
        biological hazards
Annex J (informative) - Information for safety and information
about residual risk
Bibliography

This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

Committee
ISO/TC 210
DevelopmentNote
Supersedes CSA ISO 14971-1. (06/2006) Supersedes CSA ISO 14971A. (07/2007)
DocumentType
Standard
ISBN
978-1-55436-513-5
Pages
100
ProductNote
Reconfirmed EN
PublisherName
Canadian Standards Association
Status
Current
Supersedes

Standards Relationship
ISO 14971:2007 Identical

IEC 61025:2006 Fault tree analysis (FTA)
ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
ISO 15198:2004 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
ISO 18153:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 19001:2013 In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
IEC 60300-3-9:1995 Dependability management - Part 3: Application guide - Section 9: Risk analysis of technological systems
ISO 17593:2007 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO/IEC Guide 2:2004 Standardization and related activities General vocabulary
EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
ISO 9000-3:1997 Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software

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