Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)

This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components.
This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.
This document establishes an approach for verifying/validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.
This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
For some heart valve substitutes (e.g. sutureless), the requirements of both this document and ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis.

Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter Herzklappenersatz (ISO 5840-2:2021)

Das Dokument ist auf Herzklappenersatz anwendbar, der für die Implantation im menschlichen Herzen vorgesehen ist, für die in der Regel ein kardiopulmonaler Bypass und direkte Sichtbarkeit erforderlich sind. Bezüglich Beispielen für chirurgisch implantierten Herzklappenersatz und dessen Bestandteilen siehe Anhang E.
Das Dokument ist sowohl auf neu entwickelten als auch auf veränderten chirurgisch implantierten Herzklappenersatz und seine Zubehörteile anwendbar und gilt für die Verpackung und die für die Implantation und die Ermittlung der geeigneten Größe des chirurgisch zu implantierenden Herzklappen¬ersatzes erforderliche Kennzeichnung.
Dieses Dokument legt eine Herangehensweise zur Verifizierung/Validierung des Designs und der Herstellung eines chirurgisch zu implantierenden Herzklappenersatzes auf der Grundlage des Risiko-managements fest. Die Auswahl der geeigneten Qualifikationsprüfungen und  verfahren leitet sich aus der Risikobeurteilung ab. Zu diesen Prüfungen können solche zur Beurteilung der physikalischen, chemischen, biologischen und mechanischen Eigenschaften eines chirurgisch zu implantierenden Herzklappenersatzes und von dessen Werkstoffen und Bauteilen gehören. Diese Prüfungen können auch die vorklinische In vivo-Bewertung und die klinische Bewertung des fertigen chirurgisch implantierten Herzklappenersatzes einschließen.
Dieses Dokument legt Betriebsbedingungen für und Leistungsanforderungen an chirurgisch implantierten Herzklappenersatz fest, sofern angemessene wissenschaftliche und/oder klinische Nachweise für deren Begründung vorliegen.
Für einige Herzklappenprothesen (z. B. nahtlos) können die Anforderungen sowohl dieses Dokuments als auch von ISO 5840 3:2021 von Bedeutung sein und werden als für das spezifische Implantatdesign anwendbar angesehen und basieren auf den Ergebnissen der Risiko¬analyse.

Implants cardiovasculaires - Prothèses valvulaires - Partie 2: Prothèse valvulaires implantées chirurgicalement (ISO 5840-2:2021)

Le présent document s'applique aux prothèses valvulaires destinées à être implantées dans un cœur humain et nécessitant en général une circulation extra-corporelle et une visualisation directe. Voir des exemples de prothèses valvulaires implantées chirurgicalement et de leurs composants à l'Annexe E.
Le présent document s'applique à la fois aux prothèses valvulaires chirurgicales récemment mises au point et aux prothèses valvulaires chirurgicales modifiées, ainsi qu'aux dispositifs auxiliaires, à l'emballage et à l'étiquetage exigés pour leur implantation. Il s'applique également à la détermination de la taille appropriée de la prothèse valvulaire chirurgicale à implanter.
Le présent document établit une approche permettant de vérifier/valider la conception et la fabrication d'une prothèse valvulaire chirurgicale dans une optique de gestion du risque. La sélection des méthodes et des essais de qualification appropriés se fait à partir de l'appréciation du risque. Les essais peuvent être destinés à évaluer les propriétés physiques, chimiques, biologiques et mécaniques de prothèses valvulaires chirurgicales ainsi que celles de leurs matériaux et composants. Ces essais peuvent également englober les essais destinés à l'évaluation préclinique in vivo et à l'évaluation clinique des prothèses valvulaires chirurgicales à l'état fini.
Le présent document définit les conditions de fonctionnement et les exigences de performance relatives aux prothèses valvulaires chirurgicales lorsqu'il existe une preuve scientifique et/ou clinique adéquate pour les justifier.
Pour certaines prothèses valvulaires chirurgicales (par exemple, les prothèses sans suture), les exigences du présent document et de l'ISO 5840-3:2021 peuvent être pertinentes. Elles sont considérées comme applicables à la conception spécifique du dispositif, dans la mesure où elles s'appuient sur les résultats de l'analyse du risque.

Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 2. del: Kirurško vsajeni (implantirani) nadomestki srčne zaklopke (ISO 5840-2:2021)

General Information

Status
Published
Publication Date
02-Feb-2021
Withdrawal Date
30-Aug-2021
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
03-Feb-2021
Completion Date
03-Feb-2021

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SLOVENSKI STANDARD
SIST EN ISO 5840-2:2021
01-marec-2021
Nadomešča:
SIST EN ISO 5840-2:2015
Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 2. del: Kirurško
vsajeni (implantirani) nadomestki srčne zaklopke (ISO 5840-2:2021)
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart
valve substitutes (ISO 5840-2:2021)
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter
Herzklappenersatz (ISO 5840-2:2021)
Implants cardiovasculaires - Prothèses valvulaires - Partie 2: Prothèse valvulaires
implantées chirurgicalement (ISO 5840-2:2021)
Ta slovenski standard je istoveten z: EN ISO 5840-2:2021
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 5840-2:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 5840-2:2021

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SIST EN ISO 5840-2:2021


EN ISO 5840-2
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2021
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 5840-2:2015
English Version

Cardiovascular implants - Cardiac valve prostheses - Part
2: Surgically implanted heart valve substitutes (ISO 5840-
2:2021)
Implants cardiovasculaires - Prothèses valvulaires - Herz- und Gefäßimplantate - Herzklappenprothesen -
Partie 2: Prothèse valvulaires implantées Teil 2: Chirurgisch implantierter Herzklappenersatz
chirurgicalement (ISO 5840-2:2021) (ISO 5840-2:2021)
This European Standard was approved by CEN on 21 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 5840-2:2021 E
worldwide for CEN national Members.

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SIST EN ISO 5840-2:2021
EN ISO 5840-2:2021 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 5840-2:2021
EN ISO 5840-2:2021 (E)
European foreword
This document (EN ISO 5840-2:2021) 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 5840-2:2015.
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 5840-2:2021 has been approved by CEN as EN ISO 5840-2:2021 without any
modification.

3

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SIST EN ISO 5840-2:2021
...

SLOVENSKI STANDARD
oSIST prEN ISO 5840-2:2019
01-marec-2019
9VDGNL LPSODQWDWL ]DVUFHLQRåLOMH3URWH]H]DVUþQR]DNORSNRGHO.LUXUãNR
YVDMHQL LPSODQWLUDQL QDGRPHVWNLVUþQH]DNORSNH ,62',6
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart
valve substitutes (ISO/DIS 5840-2:2019)
Implants cardiovasculaires - Prothèses valvulaires - Partie 2: Prothèse valvulaires
implantées chirurgicalement (ISO/DIS 5840-2:2019)
Ta slovenski standard je istoveten z: prEN ISO 5840-2
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 5840-2:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 5840-2:2019

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oSIST prEN ISO 5840-2:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5840-2
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-01-14 2019-04-08
Cardiovascular implants — Cardiac valve prostheses —
Part 2:
Surgically implanted heart valve substitutes
Implants cardiovasculaires — Prothèses valvulaires —
Partie 2: Prothèse valvulaires implantées chirurgicalement
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 5840-2:2019(E)
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 SUPPORTING DOCUMENTATION. ISO 2019

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oSIST prEN ISO 5840-2:2019
ISO/DIS 5840-2:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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 2019 – All rights reserved

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oSIST prEN ISO 5840-2:2019
ISO/DIS 5840-2:2019(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee
...

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