|
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
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: [email protected]
Website: www.iso.org
Published in Switzerland
ii
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
iii
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
iv
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
...