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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
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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
BS EN ISO 14971:2019+A11:2021
$198.66