BS EN ISO 14971:2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical devices. Application of risk management to medical devices
Hardcopy , PDF
15-12-2021
English
31-07-2012
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
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