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BS EN ISO 14971:2019+A11:2021 Medical devices. Application of risk management to medical devices >
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BS EN ISO 14971:2019+A11:2021 Medical devices. Application of risk management to medical devices, 2021
- undefined
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements for risk management system
- 4.1 Risk management process
- 4.2 Management responsibilities
- 4.3 Competence of personnel
- 4.4 Risk management plan
- 4.5 Risk management file
- 5 Risk analysis
- 5.1 Risk analysis process
- 5.2 Intended use and reasonably foreseeable misuse
- 5.3 Identification of characteristics related to safety
- 5.4 Identification of hazards and hazardous situations
- 5.5 Risk estimation
- 6 Risk evaluation
- 7 Risk control
- 7.1 Risk control option analysis
- 7.2 Implementation of risk control measures
- 7.3 Residual risk evaluation
- 7.4 Benefit-risk analysis
- 7.5 Risks arising from risk control measures
- 7.6 Completeness of risk control
- 8 Evaluation of overall residual risk
- 9 Risk management review
- 10 Production and post-production activities
- 10.1 General
- 10.2 Information collection
- 10.3 Information review
- 10.4 Actions
- Annex A (informative) Rationale for requirements
- Annex B (informative) Risk management process for medical devices
- Annex C (informative) Fundamental risk concepts
- Bibliography [Go to Page]
