DIN EN ISO 14971:2013-04

National foreword
National Annex NA (informative) - Bibliography
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
Annex ZA (informative) - Relationship between this European
         Standard and Requirements of EU Directive 93/42/EE
         on Medical Devices
Annex ZB (informative) - Relationship between this European
         Standard and Requirements of EU Directive
         90/385/EEC on Active Implantable Medical Devices
Annex ZC (informative) - Relationship between this European
         Standard and Requirements of EU Directive 98/79/EC
         on In Vitro Diagnostic Medical Devices

This standard is included in DIN Handbook 267-5, 268 and 469.