ISO 5910:2024
(Main)Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
1.1 This document specifies an approach for verifying and validating the design and manufacture of a heart valve repair system through risk management. The selection of appropriate verification and validation tests and methods are derived from the risk assessment. The tests include assessments of the physical, chemical, biological and mechanical properties of components and materials of heart valve repair systems. The tests also include preclinical in vivo evaluation and clinical investigation of the finished heart valve repair system to assess the safety and effectiveness of the heart valve repair system. NOTE For the purposes of this document, effectiveness end point includes clinical performance and benefits. 1.2 This document defines operational conditions and performance requirements for heart valve repair systems where adequate scientific and/or clinical evidence exists for their justification. It also describes the labels and packaging of the device. 1.3 This document applies to all heart valve repair systems that have an intended use to repair and/or improve the function of native human heart valves by acting either on the valve apparatus or on the adjacent anatomy (e.g. ventricle, coronary sinus). 1.4 This document does not apply to cardiac resynchronization therapy (CRT) devices, paravalvular leakage closure devices, systems that do not leave an implant in place (e.g. ablation, radio frequency annuloplasty), apical conduits and devices with components containing viable cells. This document also excludes materials not intended for repairing and/or improving the function of human heart valves according to its intended use (e.g. patch material and sutures used in general surgical practice). NOTE A rationale for the provisions of this document is given in Annex A.
Implants cardiovasculaires et circuits extra-corporels — Dispositifs de réparation de valves cardiaques
General Information
Relations
Standards Content (Sample)
International
Standard
ISO 5910
Second edition
Cardiovascular implants and
2024-07
extracorporeal systems — Cardiac
valve repair devices
Implants cardiovasculaires et circuits extra-corporels —
Dispositifs de réparation de valves cardiaques
Reference number
© ISO 2024
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Contents Page
Foreword .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Abbreviated terms . 9
5 Fundamental requirements . 10
5.1 General .10
5.2 Risk management .10
6 Device design .10
6.1 Intended use and indication for use .10
6.2 Design inputs .10
6.2.1 General .10
6.2.2 Operational specifications .10
6.2.3 Functional, performance and safety requirements . 12
6.2.4 Usability . 13
6.2.5 Packaging, labelling and sterilization . 13
6.3 Design outputs . 13
6.4 Design transfer (manufacturing verification and validation) . 13
7 Design verification testing and analysis, and design validation . 14
7.1 General requirements .14
7.2 In vitro assessment.14
7.2.1 General .14
7.2.2 Test articles, sample selection, test conditions and reporting requirements .14
7.2.3 Device material property assessment . .16
7.2.4 Device durability assessment .17
7.2.5 Device corrosion assessment .17
7.2.6 Design specific testing .17
7.2.7 Visibility .17
7.2.8 Simulated use assessment .18
7.2.9 Human factors and usability assessment .18
7.2.10 Device MRI safety .18
7.3 Preclinical in vivo evaluation .18
7.3.1 General .18
7.3.2 Overall requirements .18
7.3.3 Methods . 20
7.3.4 Test report .21
7.4 Clinical investigations . 22
7.4.1 General . 22
7.4.2 Study considerations . 22
7.4.3 Study end points .24
7.4.4 Ethical considerations . 25
7.4.5 Distribution of subjects and investigators . 25
7.4.6 Statistical considerations including sample size and duration . 26
7.4.7 Patient selection criteria .27
7.4.8 Clinical data requirements . 28
7.4.9 Clinical investigation analysis and reporting . .31
7.4.10 Post-market clinical follow-up .31
8 Manufacturing verification and validation .32
Annex A (informative) Rationale for the provisions of this document .33
Annex B (informative) Types and examples of heart valve repair devices and delivery systems .36
Annex C (normative) Packaging .43
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Annex D (normative) Product labels, instructions for use and training .44
Annex E (normative) Sterilization . 47
Annex F (informative) Heart valve repair system characteristics .48
Annex G (informative) Example of a transcatheter heart valve repair system hazard analysis .50
Annex H (informative) In vitro test guidelines for paediatric devices .51
Annex I (informative) Identification of boundary conditions .54
Annex J (informative) Test platforms for in vitro testing .58
Annex K (informative) Considerations for device material properties undergoing alterations
post implantation .60
Annex L (informative) Corrosion assessment . 61
Annex M (informative) Durability assessment .64
Annex N (informative) Additional device design evaluation considerations .71
Annex O (normative) Delivery system design evaluation . 74
Annex P (informative) Preclinical ex vivo and in vivo evaluations . 76
Annex Q (normative) Adverse event classification during clinical investigation .80
Annex R (informative) Multimodality imaging of TAVr, TMVr and TTVr (pre-, peri- and post-
implantation) .86
Annex S (informative) Clinical investigation end points for valve repair devices: Suggestions
for end points and their timing .91
Bibliography .95
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrot
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