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BS ISO 5910:2024

BS ISO 5910:2024

$215.11

Cardiovascular implants and extracorporeal systems. Cardiac valve repair devices

Published By Publication Date Number of Pages
BSI 2024 108
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PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
9 1 Scope
2 Normative references
10 3 Terms and definitions
17 4 Abbreviated terms
18 5 Fundamental requirements
5.1 General
5.2 Risk management
6 Device design
6.1 Intended use and indication for use
6.2 Design inputs
6.2.1 General
6.2.2 Operational specifications
20 6.2.3 Functional, performance and safety requirements
21 6.2.4 Usability
6.2.5 Packaging, labelling and sterilization
6.3 Design outputs
6.4 Design transfer (manufacturing verification and validation)
22 7 Design verification testing and analysis, and design validation
7.1 General requirements
7.2 In vitro assessment
7.2.1 General
7.2.2 Test articles, sample selection, test conditions and reporting requirements
24 7.2.3 Device material property assessment
25 7.2.4 Device durability assessment
7.2.5 Device corrosion assessment
7.2.6 Design specific testing
7.2.7 Visibility
26 7.2.8 Simulated use assessment
7.2.9 Human factors and usability assessment
7.2.10 Device MRI safety
7.3 Preclinical in vivo evaluation
7.3.1 General
7.3.2 Overall requirements
28 7.3.3 Methods
29 7.3.4 Test report
30 7.4 Clinical investigations
7.4.1 General
7.4.2 Study considerations
32 7.4.3 Study end points
33 7.4.4 Ethical considerations
7.4.5 Distribution of subjects and investigators
34 7.4.6 Statistical considerations including sample size and duration
35 7.4.7 Patient selection criteria
36 7.4.8 Clinical data requirements
39 7.4.9 Clinical investigation analysis and reporting
7.4.10 Post-market clinical follow-up
40 8 Manufacturing verification and validation
41 Annex A (informative) Rationale for the provisions of this document
44 Annex B (informative) Types and examples of heart valve repair devices and delivery systems
51 Annex C (normative) Packaging
52 Annex D (normative) Product labels, instructions for use and training
55 Annex E (normative) Sterilization
56 Annex F (informative) Heart valve repair system characteristics
58 Annex G (informative) Example of a transcatheter heart valve repair system hazard analysis
59 Annex H (informative) In vitro test guidelines for paediatric devices
62 Annex I (informative) Identification of boundary conditions
66 Annex J (informative) Test platforms for in vitro testing
68 Annex K (informative) Considerations for device material properties undergoing alterations post implantation
69 Annex L (informative) Corrosion assessment
72 Annex M (informative) Durability assessment
79 Annex N (informative) Additional device design evaluation considerations
82 Annex O (normative) Delivery system design evaluation
84 Annex P (informative) Preclinical ex vivo and in vivo evaluations
88 Annex Q (normative) Adverse event classification during clinical investigation
94 Annex R (informative) Multimodality imaging of TAVr, TMVr and TTVr (pre-, peri- and post-implantation)
99 Annex S (informative) Clinical investigation end points for valve repair devices: Suggestions for end points and their timing
103 Bibliography

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BS ISO 5910:2024
$215.11