ISO 5840-2:2021/FDAmd 1

Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes — Amendment 1

Implants cardiovasculaires — Prothèses valvulaires — Partie 2: Prothèses valvulaires implantées chirurgicalement — Amendement 1

General Information

• Status: Not Published
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
• Drafting Committee: ISO/TC 150/SC 2/WG 1 - Cardiac valves
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 17-Dec-2024
• Due Date: 17-Dec-2024
• Completion Date: 17-Dec-2024

Relations

• Amends: ISO 5840-2:2021 - Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
• Effective Date: 25-Nov-2023

Standards Content (Sample)

FINAL DRAFT
Amendment
ISO 5840-2:2021/
FDAM 1
ISO/TC 150/SC 2
Cardiovascular implants — Cardiac
Secretariat: ANSI
valve prostheses —
Voting begins on:
2024-12-17
Part 2:
Surgically implanted heart valve
Voting terminates on:
2025-02-11
substitutes
AMENDMENT 1
Implants cardiovasculaires — Prothèses valvulaires —
Partie 2: Prothèse valvulaires implantées chirurgicalement
AMENDEMENT 1
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-
ISO/CEN PARALLEL PROCESSING 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 5840-2:2021/FDAM 1:2024(en) © ISO 2024

FINAL DRAFT
ISO 5840-2:2021/FDAM 1:2024(en)
Amendment
ISO 5840-2:2021/
FDAM 1
ISO/TC 150/SC 2
Cardiovascular implants — Cardiac
Secretariat: ANSI
valve prostheses —
Voting begins on:
Part 2:
Surgically implanted heart valve
Voting terminates on:
substitutes
AMENDMENT 1
Implants cardiovasculaires — Prothèses valvulaires —
Partie 2: Prothèse valvulaires implantées chirurgicalement
AMENDEMENT 1
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-
ISO/CEN PARALLEL PROCESSING
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO 5840-2:2021/FDAM 1:2024(en) © ISO 2024

ii
ISO 5840-2:2021/FDAM 1:2024(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 o
...

ISO 5840-1:2021/DAM:2024(E)FDAmd 1
ISO/TC 150/SC 2/WG 1
Secretariat: ANSI
Date: 2024-12-02
Cardiovascular implants — Cardiac valve prostheses — —
Part 1:
General requirements
Amendment AMENDMENT 1
Date: 2024-09-23
ISO #####-#:####(X)
Implants cardiovasculaires — Prothèses valvulaires —
Partie 1: Exigences générales
AMENDEMENT 1
FDIS stage
2 © ISO #### – All rights reserved

ISO 5840-1:2021/FDAmd 1(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 copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Email: E-mail: [e-mail]
Website: www.iso.org
Published in Switzerland.
iii
ISO 5840-1:2021/FDAmd 1(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
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.
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).
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.
iv
ISO 5840-1:2021/FDAmd 1(en)
Cardiovascular implants — Cardiac valve prostheses —
—
Part 1:
General requirements —
Amendment
AMENDMENT 1
Clause 3, Terms and definitions
3.1
Replace the definition with the following:
device-specific tool that is required to assist in the implantation and/or adjustment of the heart valve
substitute (3.30), excluding the delivery system

3.2
Replace the terminologicalterm entry for "adverse event" with the following:
adverse event
AE
untoward medical occurrence, disease or injury, or clinical signs (including abnormal laboratory
findings) in patients, whether or not related to the investigational medical device and whether
anticipated or unanticipated. For users or other persons, this definition is restricted to events related
to the use of investigational medical devices or comparators, whether anticipated or unanticipated.
Note 1Note 1 to entry: For users or other persons, this definition is restricted to events related to the use of
investigational medical devices or comparators, whether anticipated or unanticipated.
Note 2 to entry: This definition includes events related to the investigational medical device or the comparator,
when applicable.
Note 3 to entry: This definition includes events related to the procedures involved.
Note 2 to entry: This definition includes events related to the procedures involved.

3.49
Replace the definition with the following:
volume of fluid that flows through and around a heart valve substitute (3.30) in the reverse direction

during one cycle (3.13) and is the sum of the closing volume (3.9) and the leakage volume (3.35)
Note 1 to entry: Clinically, it might only be possible to measure the leakage volume and might not include
the closing volume.
Note 2 to entry: See Figure 2.

ISO 5840-1:2021/FDAmd 1(en)
7.2.2.2, Table 3
Replace Tabl
...

PROJET FINAL
Amendement
ISO 5840-2:2021/
FDAM 1
ISO/TC 150/SC 2
Implants cardiovasculaires —
Secrétariat: ANSI
Prothèses valvulaires —
Début de vote:
2024-12-17
Partie 2:
Prothèses valvulaires implantées
Vote clos le:
2025-02-11
chirurgicalement
AMENDEMENT 1
Cardiovascular implants — Cardiac valve prostheses —
Part 2: Surgically implanted heart valve substitutes
AMENDMENT 1
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
Numéro de référence
ISO 5840-2:2021/FDAM 1:2024(fr) © ISO 2024

PROJET FINAL
ISO 5840-2:2021/FDAM 1:2024(fr)
Amendement
ISO 5840-2:2021/
FDAM 1
ISO/TC 150/SC 2
Implants cardiovasculaires —
Secrétariat: ANSI
Prothèses valvulaires —
Début de vote:
Partie 2: 2024-12-17
Prothèses valvulaires implantées
Vote clos le:
2025-02-11
chirurgicalement
AMENDEMENT 1
Cardiovascular implants — Cardiac valve prostheses —
Part 2: Surgically implanted heart valve substitutes
AMENDMENT 1
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
© ISO 2024 INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
NORMES POUVANT
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: [phone]
E-mail: [e-mail]
Web: www.iso.org
Publié en Suisse Numéro de référence
ISO 5840-2:2021/FDAM 1:2024(fr) © ISO 2024

ii
ISO 5840-2:2021/FDAM 1:2024(fr)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes nationaux
de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est en général
confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude a le droit de faire
partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l’ISO participent également aux travaux. L’ISO collabore étroitement avec
la Commission électrotechnique internationale (IEC) en ce qui concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a
été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir
www.iso.org/directives).
L’ISO attire l’attention sur le fait que la mise en application du présent document peut entraîner l’utilisation
d’un ou de plusieurs brevets. L’ISO ne prend pas position quant à la preuve, à la validité et à l’applicabilité de
tout droit de brevet revendiqué à cet égard. À
...