EN ISO 5840-2:2021
(Main)Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
INTERNATIONAL ISO
STANDARD 5840-2
Second edition
2021-01
Cardiovascular implants — Cardiac
valve prostheses —
Part 2:
Surgically implanted heart valve
substitutes
Implants cardiovasculaires — Prothèses valvulaires —
Partie 2: Prothèse valvulaires implantées chirurgicalement
Reference number
ISO 5840-2:2021(E)
©
ISO 2021
ISO 5840-2:2021(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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ISO 5840-2:2021(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations. 3
5 Fundamental requirements . 4
6 Device description . 4
6.1 General . 4
6.2 Intended use . 4
6.3 Design inputs . 4
6.3.1 Operational specifications . 4
6.3.2 Performance specifications . 4
6.3.3 Packaging, labelling, and sterilization . 5
6.4 Design outputs . 5
6.5 Design transfer (manufacturing verification/validation) . 5
6.6 Risk management . 6
7 Design verification and validation . 6
7.1 General requirements . 6
7.2 In vitro assessment . 6
7.2.1 General. 6
7.2.2 Test conditions, sample selection, and reporting requirements . 6
7.2.3 Material property assessment . 6
7.2.4 Hydrodynamic performance assessment . 6
7.2.5 Structural performance assessment . 7
7.2.6 Design- or procedure-specific testing. 8
7.2.7 Device MRI compatibility . 8
7.2.8 Simulated use. 8
7.2.9 Human factors/usability assessment . 8
7.2.10 Implant thrombogenic and haemolytic potential assessment . 8
7.3 Preclinical in vivo evaluation . 8
7.3.1 General. 8
7.3.2 Overall requirements . 8
7.3.3 Methods . 9
7.3.4 Test report .10
7.4 Clinical investigations .11
7.4.1 General.11
7.4.2 Study considerations .12
7.4.3 Study endpoints .13
7.4.4 Ethical considerations .14
7.4.5 Pivotal studies: Distribution of subjects and investigators .14
7.4.6 Statistical considerations including sample size and duration .15
7.4.7 Patient selection criteria .16
7.4.8 Valve thrombosis prevention .17
7.4.9 Clinical data requirements .17
Annex A (informative) Surgical heart valve substitute hazard analysis example .22
Annex B (informative) In vitro procedures for testing unstented or similar valves in
compliant chambers .24
Annex C (informative) Preclinical in vivo evaluation .
...
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