ISO 5910:2024

FINAL DRAFT
International
Standard
ISO/FDIS 5910
ISO/TC 150/SC 2
Cardiovascular implants and
Secretariat: ANSI
extracorporeal systems — Cardiac
Voting begins on:
valve repair devices
2024-04-16
Implants cardiovasculaires et circuits extra-corporels —
Voting terminates on:
Dispositifs de réparation de valves cardiaques
2024-06-11
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 5910:2024(en) © ISO 2024

FINAL DRAFT
ISO/FDIS 5910:2024(en)
International
Standard
ISO/FDIS 5910
ISO/TC 150/SC 2
Cardiovascular implants and
Secretariat: ANSI
extracorporeal systems — Cardiac
Voting begins on:
valve repair devices
Implants cardiovasculaires et circuits extra-corporels —
Voting terminates on:
Dispositifs de réparation de valves cardiaques
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 5910:2024(en) © ISO 2024

ii
ISO/FDIS 5910:2024(en)
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 .13
7.1 General requirements . 13
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 .16
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 .17
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 .19
7.3.4 Test report . 20
7.4 Clinical investigations .21
7.4.1 General .21
7.4.2 Study considerations . 22
7.4.3 Study end points .24
7.4.4 Ethical considerations .24
7.4.5 Distribution of subjects and investigators .24
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 . . 30
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
ISO/FDIS 5910:2024(en)
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)
...

ISO/DISFDIS 5910:2023(E)
ISO/TC 150/SC 2
Secretariat: ANSI
Date: 2024-03-28
Cardiovascular implants and extracorporeal systems — Cardiac
valve repair devices
Implants cardiovasculaires et circuits extra-corporels — Dispositifs de réparation de valves cardiaques
Second edition
Date: 2023-07-26
FDIS stage
ISO/FDIS 5910:2024(en)
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'sISO’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: E-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland.
iii
ISO/FDIS 5910:2024(en)
Contents Page
Foreword . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 3
4 Abbreviated terms . 10
5 Fundamental requirements . 11
5.1 General . 11
5.2 Risk management . 11
6 Device design . 11
6.1 Intended use and indication for use . 11
6.2 Design inputs . 11
6.2.1 General . 11
6.2.2 Operational specifications . 11
6.2.3 Functional, performance and safety requirements . 13
6.2.4 Usability . 14
6.2.5 Packaging, labelling and sterilization . 14
6.3 Design outputs . 14
6.4 Design transfer (manufacturing verification and validation) . 14
7 Design verification testing and analysis, and design validation . 15
7.1 General requirements . 15
7.2 In vitro assessment . 15
7.2.1 General . 15
7.2.2 Test articles, sample selection, test conditions and reporting requirements . 15
7.2.3 Device material property assessment . 17
7.2.4 Device durability assessment . 18
7.2.5 Device corrosion assessment . 19
7.2.6 Design specific testing . 19
7.2.7 Visibility . 19
7.2.8 Simulated use assessment . 19
7.2.9 Human factors and usability assessment . 19
7.2.10 Device MRI safety . 20
7.3 Preclinical in vivo evaluation . 20
7.3.1 General . 20
7.3.2 Overall requirements . 20
7.3.3 Methods . 22
7.3.4 Test report . 23
7.4 Clinical investigations . 23
7.4.1 General . 23
7.4.2 Study considerations . 24
7.4.3 Study end points . 27
7.4.4 Ethical considerations . 27
7.4.5 Distribution of subjects and investigators . 27
7.4.6 Statistical considerations including sample size and duration . 28
7.4.7 Patient selection criteria . 30
7.4.8 Clinical data requirements . 31
7.4.9 Clinical investigation analysis and reporting . 34
7.4.10 Post-market clinical follow-up . 34
8 Manufacturing verification and validation . 35
iv
ISO/FDIS 5910:2024(en)
Annex A (informative) Rationale for the provisions of this document . 36
Bibliography . 97

v
ISO/FDIS 5910:2024(en)
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 Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of
ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
http://www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This document was prepared by ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular
implants and extracorporeal systems.
This second edition cancels and replaces the first edition (ISO 5910:2018), which has been technically revised.
The main changes are as follows:
— — added normative requirements (7.2.2.3)in 7.2.2.3 and an informative annex (Annex J(Annex J) on )
have been added for test platforms;
— — removed normative requirements and the informative annex on functional performance assessment
have been removed;
— — combined fatigue and durability testing have been combined into integrated device assessment
(7.2.4in 7.2.4 and Annex MAnnex M);;
— — movedthe description of the types of heart valve repair devices, including the added section on
robotically-assisted systems, have been moved into Annex BAnnex B;;
— Annex G— extensively revised annexes on hazard and failure modes (Annex G) and Annex R on clinical
imaging (Annex R);have been extensively revised;
— — clarified pulsatile flow conditions for the paediatric population have been clarified in Annex HAnnex
H;;
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ISO/FDIS 5910:2024(en)
— Annex I— added annex covering on boundary conditions (Annex I);has been added;
— — removed annexes on physical and material property definitions and material property testing have
been removed;
— — included additional device design evaluation requirements have been included in Annex N(Annex N);;
— — included additional evaluation considerations for preclinical in vivo evaluations have been included in
Annex P(Annex P).
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
vii
ISO/FDIS 5910:2024(en)
Cardiovascular implants and extracorporeal systems — Cardiac valve
repair devices
1 Scope
1.1 This document is applicable 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).
1.21.1 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 endpointend point includes clinical performance and
benefits.
1.32 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
...