BS EN ISO 14971:2019+A11:2021
$198.66
Medical devices. Application of risk management to medical devices
Published By | Publication Date | Number of Pages |
BSI | 2021 | 56 |
PDF Catalog
PDF Pages | PDF Title |
---|---|
2 | undefined |
14 | Foreword |
16 | Introduction |
19 | 1 Scope 2 Normative references 3 Terms and definitions |
25 | 4 General requirements for risk management system 4.1 Risk management process |
26 | 4.2 Management responsibilities |
27 | 4.3 Competence of personnel 4.4 Risk management plan |
28 | 4.5 Risk management file 5 Risk analysis 5.1 Risk analysis process 5.2 Intended use and reasonably foreseeable misuse |
29 | 5.3 Identification of characteristics related to safety 5.4 Identification of hazards and hazardous situations 5.5 Risk estimation |
30 | 6 Risk evaluation 7 Risk control 7.1 Risk control option analysis |
31 | 7.2 Implementation of risk control measures 7.3 Residual risk evaluation |
32 | 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 |
33 | 9 Risk management review 10 Production and post-production activities 10.1 General 10.2 Information collection |
34 | 10.3 Information review 10.4 Actions |
35 | Annex A (informative) Rationale for requirements |
44 | Annex B (informative) Risk management process for medical devices |
48 | Annex C (informative) Fundamental risk concepts |
54 | Bibliography |