Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021)

Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 3: Durch minimal-invasive Methoden implantierter Herzklappenersatz (ISO 5840-3:2021)

Dieses Dokument ist auf alle Medizinprodukte anwendbar, die für die Implantation als Transkatheter-Herzklappenersatz vorgesehen sind.
Dieses Dokument ist auf Transkatheter-Herzklappenersatz und dessen Zubehörteile anwendbar und gilt darüber hinaus für die Verpackung und die für die Implantation und Bestimmung der geeigneten Größe des zu implantierenden Herzklappenersatzes erforderliche Kennzeichnung.
Dieses Dokument legt eine Herangehensweise zur Verifizierung/Validierung des Designs und der Herstellung eines Transkatheter-Herzklappenersatzes auf der Grundlage des Risikomanagements fest. Die Auswahl der geeigneten Prüfungen und Verfahren der Verifizierung/Validierung muss sich aus der Risiko¬beurteilung ableiten. Zu diesen Prüfungen können solche zur Beurteilung der physikalischen, chemischen, biologischen und mechanischen Eigenschaften eines Herzklappenersatzes und von dessen Werkstoffen und Bauteilen gehören. Diese Prüfungen können auch die vorklinische In vivo-Bewertung und die klinische Bewertung des fertigen Herzklappenersatzes einschließen.
Dieses Dokument legt Betriebsbedingungen für und Leistungsanforderungen an Transkatheter-Herz-klappenersatz fest, sofern angemessene wissenschaftliche und/oder klinische Nachweise für deren Begründung vorliegen.
Dieses Dokument enthält Betrachtungen zur Implantation eines Transkatheter-Herzklappenersatzes in eine bereits vorhandene Prothese (z. B. Klappe-in-Klappe- und Klappe-in-Ring-Konfigurationen).

Implants cardiovasculaires - Prothèses valvulaires - Partie 3: Valves cardiaques de substitution implantées par des techniques transcathéter (ISO 5840-3:2021)

Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 3. del: Nadomestki srčne zaklopke, vsajeni (implantirani) s transkatetrsko metodo (ISO 5840-3:2021)

General Information

Status
Published
Public Enquiry End Date
19-Mar-2019
Publication Date
21-Feb-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Feb-2021
Due Date
18-Apr-2021
Completion Date
22-Feb-2021

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SLOVENSKI STANDARD
SIST EN ISO 5840-3:2021
01-marec-2021
Nadomešča:
SIST EN ISO 5840-3:2013
Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 3. del:
Nadomestki srčne zaklopke, vsajeni (implantirani) s transkatetrsko metodo (ISO
5840-3:2021)

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes

implanted by transcatheter techniques (ISO 5840-3:2021)

Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 3: Durch minimal-invasive

Methoden implantierter Herzklappenersatz (ISO 5840-3:2021)

Implants cardiovasculaires - Prothèses valvulaires - Partie 3: Valves cardiaques de

substitution implantées par des techniques transcathéter (ISO 5840-3:2021)
Ta slovenski standard je istoveten z: EN ISO 5840-3:2021
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 5840-3:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 5840-3:2021
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SIST EN ISO 5840-3:2021
EN ISO 5840-3
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2021
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 5840-3:2013
English Version
Cardiovascular implants - Cardiac valve prostheses - Part
3: Heart valve substitutes implanted by transcatheter
techniques (ISO 5840-3:2021)

Implants cardiovasculaires - Prothèses valvulaires - Herz- und Gefäßimplantate - Herzklappenprothesen -

Partie 3: Valves cardiaques de substitution implantées Teil 3: Durch minimal-invasive Methoden

par des techniques transcathéter (ISO 5840-3:2021) implantierter Herzklappenersatz (ISO 5840-3:2021)

This European Standard was approved by CEN on 22 September 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5840-3:2021 E

worldwide for CEN national Members.
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SIST EN ISO 5840-3:2021
EN ISO 5840-3:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 5840-3:2021
EN ISO 5840-3:2021 (E)
European foreword

This document (EN ISO 5840-3:2021) has been prepared by Technical Committee ISO/TC 150

"Implants for surgery" in collaboration with Technical Committee CEN/TC 285 “Non-active surgical

implants” the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by August 2021, and conflicting national standards shall

be withdrawn at the latest by August 2021.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 5840-3:2013.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 5840-3:2021 has been approved by CEN as EN ISO 5840-3:2021 without any

modification.
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SIST EN ISO 5840-3:2021
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SIST EN ISO 5840-3:2021
INTERNATIONAL ISO
STANDARD 5840-3
Second edition
2021-01
Cardiovascular implants — Cardiac
valve prostheses —
Part 3:
Heart valve substitutes implanted by
transcatheter techniques
Implants cardiovasculaires — Prothèses valvulaires —
Partie 3: Valves cardiaques de substitution implantées par des
techniques transcathéter
Reference number
ISO 5840-3:2021(E)
ISO 2021
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SIST EN ISO 5840-3:2021
ISO 5840-3:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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SIST EN ISO 5840-3:2021
ISO 5840-3:2021(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Abbreviations........................................................................................................................................................................................................... 4

5 Fundamental requirements ...................................................................................................................................................................... 5

6 Device description .............................................................................................................................................................................................. 5

6.1 General ........................................................................................................................................................................................................... 5

6.2 Intended use .............................................................................................................................................................................................. 6

6.3 Design inputs ............................................................................................................................................................................................ 6

6.3.1 Operational specifications ....................................................................................................................................... 6

6.3.2 Performance specifications .................................................................................................................................... 6

6.3.3 Implant procedure.......................................................................................................................................................... 7

6.3.4 Packaging, labelling and sterilization ............................................................................................................ 7

6.4 Design outputs ........................................................................................................................................................................................ 7

6.5 Design transfer (manufacturing verification/validation) .................................................................................. 7

6.6 Risk management ................................................................................................................................................................................. 7

7 Design verification and validation ..................................................................................................................................................... 8

7.1 General requirements ....................................................................................................................................................................... 8

7.2 In vitro assessment ............................................................................................................................................................................ 8

7.2.1 General...................................................................................................................................................................................... 8

7.2.2 Test conditions, sample selection and reporting requirements ............................................. 8

7.2.3 Material property assessment ............................................................................................................................. 8

7.2.4 Hydrodynamic performance assessment ................................................................................................... 8

7.2.5 Structural performance assessment ............................................................................................................10

7.2.6 Design- or procedure-specific testing.........................................................................................................10

7.2.7 Device MRI compatibility ......................................................................................................................................12

7.2.8 Simulated use...................................................................................................................................................................12

7.2.9 Human factors and usability assessment ................................................................................................12

7.2.10 Implant thrombogenic and haemolytic potential assessment ..............................................12

7.3 Preclinical in vivo evaluation ..................................................................................................................................................12

7.3.1 General...................................................................................................................................................................................12

7.3.2 Overall requirements ................................................................................................................................................13

7.3.3 Methods ................................................................................................................................................................................14

7.3.4 Test report ..........................................................................................................................................................................15

7.4 Clinical investigations ....................................................................................................................................................................16

7.4.1 General...................................................................................................................................................................................16

7.4.2 Study considerations .................................................................................................................................................17

7.4.3 Study endpoints .............................................................................................................................................................18

7.4.4 Ethical considerations ..............................................................................................................................................19

7.4.5 Pivotal studies: Distribution of subjects and investigators ......................................................19

7.4.6 Statistical considerations including sample size and duration ............................................20

7.4.7 Patient selection criteria ........................................................................................................................................22

7.4.8 Valve thrombosis prevention .............................................................................................................................22

7.4.9 Clinical data requirements ...................................................................................................................................23

Annex A (informative) Description of the transcatheter heart valve system ..........................................................28

Annex B (informative) Transcatheter heart valve substitute hazard analysis example ..............................30

Annex C (informative) Guidelines for verification of hydrodynamic performance —

Pulsatile flow testing .....................................................................................................................................................................................32

© ISO 2021 – All rights reserved iii
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SIST EN ISO 5840-3:2021
ISO 5840-3:2021(E)

Annex D (normative) Requirements for delivery system design and evaluation ...............................................40

Annex E (informative) Examples of design specific testing .......................................................................................................42

Annex F (informative) Preclinical in vivo evaluation ........................................................................................................................44

Annex G (normative) Adverse event classification during clinical investigation ...............................................47

Annex H (informative) Multimodality imaging of TAVI and TMVI pre, peri and post-

implantation assessments — Examples ....................................................................................................................................53

Bibliography .............................................................................................................................................................................................................................56

iv © ISO 2021 – All rights reserved
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SIST EN ISO 5840-3:2021
ISO 5840-3:2021(E)
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 documents 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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

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.

This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee

SC 2, Cardiovascular implants and extracorporeal systems, in collaboration with the European Committee

for Standardization (CEN) Technical Committee CEN/TC 285, Non-active surgical implants, in accordance

with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This second edition cancels and replaces the first edition (ISO 5840-3:2013), which has been technically

revised.

The main changes compared to the previous edition are as follows: the engineering and clinical

requirements in the ISO 5840 series have been updated to current specifications and integrated and

harmonized across all parts.
A list of all parts in the ISO 5840 series can be found on the ISO website.

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.
© ISO 2021 – All rights reserved v
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SIST EN ISO 5840-3:2021
ISO 5840-3:2021(E)
Introduction

This document has been prepared for transcatheter heart valve substitutes with emphasis on providing

guidance for in vitro testing, preclinical in vivo and clinical evaluations, reporting of all in vitro,

preclinical in vivo, and clinical evaluations and labelling and packaging of the device. This process is

intended to clarify the required procedures prior to market release and to enable prompt identification

and management of any subsequent issues.
This document is used in conjunction with ISO 5840-1 and ISO 5840-2.
vi © ISO 2021 – All rights reserved
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SIST EN ISO 5840-3:2021
INTERNATIONAL STANDARD ISO 5840-3:2021(E)
Cardiovascular implants — Cardiac valve prostheses —
Part 3:
Heart valve substitutes implanted by transcatheter
techniques
1 Scope

This document is applicable to all devices intended for implantation as a transcatheter heart valve

substitute.

This document is applicable to transcatheter heart valve substitutes and to the accessory devices,

packaging and labelling required for their implantation and for determining the appropriate size of

heart valve substitute to be implanted.

This document establishes an approach for verifying/validating the design and manufacture of

a transcatheter heart valve substitute through risk management. The selection of appropriate

verification/validation tests and methods are to be derived from the risk assessment. The tests can

include those to assess the physical, chemical, biological and mechanical properties of heart valve

substitutes and of their materials and components. The tests can also include those for preclinical in

vivo evaluation and clinical evaluation of the finished heart valve substitute.

This document defines operational conditions and performance requirements for transcatheter heart

valve substitutes where adequate scientific and/or clinical evidence exists for their justification.

This document includes considerations for implantation of a transcatheter heart valve substitute inside

a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 5840-1:2021, Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements

ISO 10993-2, Biological evaluation of medical devices — Part 2: Animal welfare requirements

ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice

ISO 14630, Non-active surgical implants — General requirements
ISO 14971, Medical devices — Application of risk management to medical devices

IEC 62366 (all parts), Medical devices — Application of usability engineering to medical devices

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 5840-1:2021 and the

following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
© ISO 2021 – All rights reserved 1
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SIST EN ISO 5840-3:2021
ISO 5840-3:2021(E)
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
acute assessment

intra-procedural and immediate post-procedural results used to assess in vivo safety and performance

Note 1 to entry: All animals entered into acute, short-term assessment will remain under general anaesthesia for

the duration of the study.
3.2
chronic assessment

long-term results following the procedure used to assess chronic in vivo safety and performance after

the animal has recovered from anaesthesia

Note 1 to entry: The endpoints and durations of these studies should be determined by risk analysis.

3.3
delivery approach

anatomical access used to deliver the implant to the implant site (e.g. transfemoral, transapical,

transseptal)
3.4
delivery system
catheter or other system used to deliver the implant to the implant site
3.5
device migration

detectable movement or displacement of the heart valve substitute from its original position within the

implant position and without device embolization
3.6
loading
crimping

process to affix or attach a transcatheter heart valve substitute onto a delivery device and collapse

the valve (i.e. reduce its diameter) for insertion via the delivery system (3.4) (e.g. catheter), performed

either during manufacture or in the clinic
3.7
neo-LVOT
neo-left ventricular outflow tract

region between native anterior mitral leaflet/ transcatheter mitral valve implantation (TMVI) and

septal wall, proximal to the aortic valve (see Figure 1)
2 © ISO 2021 – All rights reserved
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SIST EN ISO 5840-3:2021
ISO 5840-3:2021(E)
Key
1 TMVI
2 native anterior mitral leaflet
3 neo-LVOT
4 septal wall
Figure 1 — Neo-LVOT formation behind a mitral leaflet
3.8
neo-sinus

region between implanted transcatheter aortic valve leaflet and native aortic leaflet/leaflet of existing

bioprosthetic valve (see Figure 2)
© ISO 2021 – All rights reserved 3
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SIST EN ISO 5840-3:2021
ISO 5840-3:2021(E)
Key
1 transcatheter aortic valve implantation (TAVI) leaflet
2 native leaflet
3 neo-sinus
4 native sinus
The arrow indicates the direction of the forward flow.
Figure 2 — Neo-sinus formation behind an aortic leaflet
3.9
repositioning

change in implant position of a partially- or fully-deployed transcatheter heart valve substitute via a

transcatheter technique, possibly requiring full or partial recapturing of the device

3.10
retrieval

removal of a partially- or fully-deployed transcatheter heart valve substitute via a transcatheter

technique
3.11
transcatheter heart valve system

implantable transcatheter device, delivery system (3.4), accessories, packaging, labels and

instructions for use
3.12
valve-in-ring

implantation of a transcatheter heart valve substitute into a pre-existing annuloplasty ring

3.13
valve-in-valve

implantation of a transcatheter heart valve substitute into a pre-existing heart valve substitute

4 Abbreviations
For the purposes of this document, the following abbreviations apply.
4 © ISO 2021 – All rights reserved
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SIST EN ISO 5840-3:2021
ISO 5840-3:2021(E)
AE adverse event
AWT accelerated wear testing
CIP clinical investigation plan
COF chronic outward force
CT computed tomography
ECG electrocardiogram
EOA effective orifice area
IFU instructions for use
LA left atrium
LAA left atrial appendage
LV left ventricle, left ventricular
LVOT left ventricular outflow tract
MRI magnetic resonance imaging
MR mitral regurgitation
PMCF post-market clinical follow-up
PVL paravalvular leakage
RMS root mean square
SAE serious adverse event

TAVI transcatheter aortic valve implantation [also known as transcatheter aortic valve

replacement (TAVR)]
TEE transoesophageal echo

TMVI transcatheter mitral valve implantation [also known as transcatheter mitral valve

replacement (TMVR)]
TTE transthoracic echo
ViV valve-in-valve
ViR valve-in-ring
5 Fundamental requirements
See ISO 5840-1:2021, Clause 5.
6 Device description
6.1 General
See ISO 5840-1:2021, 6.1.
© ISO 2021 – All rights reserved 5
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SIST EN ISO 5840-3:2021
ISO 5840-3:2021(E)
6.2 Intended use
See ISO 5840-1:2021, 6.2.
6.3 Design inputs
6.3.1 Operational specifications
See ISO 5840-1:2021, 6.3.1.
6.3.2 Performance specifications
6.3.2.1 General

See ISO 5840-1:2021, 6.3.2 for general requirements. Specific transcatheter system requirements are

listed in 6.3.2.2 to 6.3.2.4. See Reference [18] for information relevant to TMVI.

6.3.2.2 Transcatheter heart valve system

The design attributes to meet the intended performance of the transcatheter heart valve system shall

take into account at least the following:

a) the visibility of the transcatheter heart valve system under fluoroscopy or other imaging modalities;

b) the deliverability and implantability in the target population.
6.3.2.3 Implantable device

The intended performance of the transcatheter heart valve substitute shall include, but not be limited

to the following:

a) the ability to be consistently, accurately and safely loaded onto the delivery system;

b) the ability to be consistently, accurately and safely deployed;
c) the ability to be safely retrieved and/or repositioned (if applicable);

d) the ability to ensure effective fixation or anchoring within the implant site;

e) the ability to maintain structural and functional integrity throughout the anticipated lifetime of

the device;

f) the ability to conform or interact with anatomical structures within the implant site (e.g. in the

aortic position, there is potential for interaction with the coronary ostia, the anterior mitral leaflet

and the conduction system; in the mitral position, there is potential for interaction with the aortic

root, LA, LAA, LVOT and the subvalvular apparatus);

g) the ability to conform or interact with previously implanted device (e.g. surgical valve, annuloplasty

ring, transcatheter valve, valve docking device), if applicable;

h) the ability to allow forward flow with an acceptably small mean pressure difference in all

anticipated configurations;

i) the ability to prevent retrograde flow with acceptably small regurgitation, including paravalvular

leakage;
j) the ability to resist migration and embolization;
k) the ability to avoid haemolysis;
l) the ability to resist thrombus formation;
6 © ISO 2021 – All rights reserved
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SIST EN ISO 5840-3:2021
ISO 5840-3:2021(E)
m) biocompatibility;

n) the ability to maintain its functionality and sterility for a reasonable shelf life prior to implantation;

o) reproducibility of function.
6.3.2.4 Delivery system
In addit
...

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