EN ISO 5840-3:2021
(Main)Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021)
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021)
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).
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)
Le présent document s'applique à tous les dispositifs destinés à être implantés en tant que prothèse valvulaire par voie transcathéter.
Le présent document s'applique aux prothèses valvulaires implantées par transcathéter 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 à implanter.
Le présent document établit une approche permettant de vérifier/valider la conception et la fabrication d'une prothèse valvulaire implantée par transcathéter dans une optique de gestion du risque. La sélection des méthodes et des essais de vérification/validation appropriés se fait à partir de l'appréciation du risque. Des essais peuvent être destinés à évaluer les propriétés physiques, chimiques, biologiques et mécaniques de prothèses valvulaires ainsi que celles de leurs matériaux et composants. Les essais peuvent également englober les essais destinés à l'évaluation préclinique in vivo et à l'évaluation clinique des prothèses valvulaires à l'état fini.
Le présent document définit les conditions de fonctionnement et les exigences de performance relatives aux prothèses valvulaires implantées par transcathéter lorsqu'il existe une preuve scientifique et/ou clinique adéquate pour les justifier.
Le présent document comprend des considérations relatives à l'implantation par transcathéter d'une prothèse valvulaire dans un dispositif prothétique préexistant (par exemple les configurations «valve-in-valve» et «valve-in-ring»).
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO 5840-3:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2021 – All rights reserved
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
Ann
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