ISO 5910:2018
(Main)Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
1.1 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). 1.2 This document outlines an approach for verifying/validating the design and manufacture of a heart valve repair system through risk management. The selection of appropriate verification/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 endpoint includes clinical performance and benefits. 1.3 This document defines operational conditions and performance requirements for heart valve repair systems where adequate scientific and/or clinical evidence exists for their justification. 1.4 This document excludes 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 Standard 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
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INTERNATIONAL ISO
STANDARD 5910
First edition
2018-06
Cardiovascular implants and
extracorporeal systems — Cardiac
valve repair devices
Implants cardiovasculaires et circuits extra-corporels — Dispositifs de
réparation de valves cardiaques
Reference number
©
ISO 2018
© ISO 2018
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Abbreviations.11
5 Fundamental requirements .12
5.1 General .12
5.2 Risk management .12
6 Device description .13
6.1 Intended use/Indication for use .13
6.2 Design inputs .13
6.2.1 General.13
6.2.2 Operational specifications .13
6.2.3 Functional, performance and safety requirements .14
6.2.4 Usability .15
6.2.5 Packaging, labelling, and sterilization .16
6.3 Design outputs .16
6.4 Design transfer (manufacturing verification/validation) .16
7 Design verification testing and analysis / Design validation .16
7.1 General requirements .16
7.2 In vitro assessment .16
7.2.1 General.16
7.2.2 Test articles, sample selection, test conditions and reporting requirements .17
7.2.3 Device material property assessment .18
7.2.4 Functional performance assessment .19
7.2.5 Device structural performance assessment .19
7.2.6 Device corrosion assessment .20
7.2.7 Delivery system design evaluation requirements .20
7.2.8 Visibility.20
7.2.9 Simulated use assessment .20
7.2.10 Human factors / Usability assessment .21
7.2.11 Device MRI safety .21
7.2.12 Design specific testing .21
7.3 Preclinical in vivo evaluation .21
7.3.1 General.21
7.3.2 Overall requirements .21
7.3.3 Methods .23
7.3.4 Test report .24
7.4 Clinical Investigations .24
7.4.1 General.24
7.4.2 Study considerations .25
7.4.3 Study endpoints .28
7.4.4 Ethical considerations .28
7.4.5 Distribution of subjects and investigators .28
7.4.6 Statistical considerations including sample size and duration .29
7.4.7 Patient selection criteria .31
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
Annex A (informative) Rationale for the provisions of this document .36
Annex B (informative) Examples of heart valve repair devices and delivery systems .39
Annex C (normative) Packaging .45
Annex D (normative) Product labels, instructions for use, and training .46
Annex E (normative) Sterilization .49
Annex F (informative) Heart valve repair system characteristics .50
Annex G (informative) Heart valve repair system hazards, associated failure modes and
evaluation methods .52
Annex H (informative) In vitro test guidelines for paediatric devices .63
Annex I (informative) Examples and definitions of some physical and material properties
of heart valve repair device components .65
Annex J (informative) Examples of standards applicable to testing of materials and
components of heart valve repair devices .79
Annex K (informative) Considerations for device material properties undergoing
alterations post implantation .85
Annex L (informative) Corrosion assessment .86
Annex M (informative) Guidelines for in vitro evaluation of functional performance of the
repair .89
Annex N (informative) Durability testing .95
Annex O (informative) Fatigue assessment .97
Annex P (informative) Preclinical in vivo evaluation .103
Annex Q (normative) Adverse event classification during clinical investigation .106
Annex R (informative) Imaging protocol .112
Annex S (informative) Clinical investigation endpoints for valve repair devices: Suggestions
for endpoints and their timing .116
Annex T (informative) Additional device design evaluation requirements .120
Annex U (informative) Guidelines for delivery system design evaluation .122
Bibliography .124
iv © ISO 2018 – All rights reserved
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
commi
...
INTERNATIONAL ISO
STANDARD 5910
First edition
2018-06
Cardiovascular implants and
extracorporeal systems — Cardiac
valve repair devices
Implants cardiovasculaires et circuits extra-corporels — Dispositifs de
réparation de valves cardiaques
Reference number
©
ISO 2018
© ISO 2018
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Abbreviations.11
5 Fundamental requirements .12
5.1 General .12
5.2 Risk management .12
6 Device description .13
6.1 Intended use/Indication for use .13
6.2 Design inputs .13
6.2.1 General.13
6.2.2 Operational specifications .13
6.2.3 Functional, performance and safety requirements .14
6.2.4 Usability .15
6.2.5 Packaging, labelling, and sterilization .16
6.3 Design outputs .16
6.4 Design transfer (manufacturing verification/validation) .16
7 Design verification testing and analysis / Design validation .16
7.1 General requirements .16
7.2 In vitro assessment .16
7.2.1 General.16
7.2.2 Test articles, sample selection, test conditions and reporting requirements .17
7.2.3 Device material property assessment .18
7.2.4 Functional performance assessment .19
7.2.5 Device structural performance assessment .19
7.2.6 Device corrosion assessment .20
7.2.7 Delivery system design evaluation requirements .20
7.2.8 Visibility.20
7.2.9 Simulated use assessment .20
7.2.10 Human factors / Usability assessment .21
7.2.11 Device MRI safety .21
7.2.12 Design specific testing .21
7.3 Preclinical in vivo evaluation .21
7.3.1 General.21
7.3.2 Overall requirements .21
7.3.3 Methods .23
7.3.4 Test report .24
7.4 Clinical Investigations .24
7.4.1 General.24
7.4.2 Study considerations .25
7.4.3 Study endpoints .28
7.4.4 Ethical considerations .28
7.4.5 Distribution of subjects and investigators .28
7.4.6 Statistical considerations including sample size and duration .29
7.4.7 Patient selection criteria .31
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
Annex A (informative) Rationale for the provisions of this document .36
Annex B (informative) Examples of heart valve repair devices and delivery systems .39
Annex C (normative) Packaging .45
Annex D (normative) Product labels, instructions for use, and training .46
Annex E (normative) Sterilization .49
Annex F (informative) Heart valve repair system characteristics .50
Annex G (informative) Heart valve repair system hazards, associated failure modes and
evaluation methods .52
Annex H (informative) In vitro test guidelines for paediatric devices .63
Annex I (informative) Examples and definitions of some physical and material properties
of heart valve repair device components .65
Annex J (informative) Examples of standards applicable to testing of materials and
components of heart valve repair devices .79
Annex K (informative) Considerations for device material properties undergoing
alterations post implantation .85
Annex L (informative) Corrosion assessment .86
Annex M (informative) Guidelines for in vitro evaluation of functional performance of the
repair .89
Annex N (informative) Durability testing .95
Annex O (informative) Fatigue assessment .97
Annex P (informative) Preclinical in vivo evaluation .103
Annex Q (normative) Adverse event classification during clinical investigation .106
Annex R (informative) Imaging protocol .112
Annex S (informative) Clinical investigation endpoints for valve repair devices: Suggestions
for endpoints and their timing .116
Annex T (informative) Additional device design evaluation requirements .120
Annex U (informative) Guidelines for delivery system design evaluation .122
Bibliography .124
iv © ISO 2018 – All rights reserved
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
commi
...
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