EN ISO 5840-1:2021
(Main)Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021)
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021)
This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements.
This document is applicable to newly developed and modified heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted.
ISO 5840-1 outlines an approach for verifying/validating the design and manufacture of a 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 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.
ISO 5840-1 defines operational conditions for heart valve substitutes.
ISO 5840-1 furthermore defines terms that are also applicable to ISO 5840-2 and ISO 5840-3.
ISO 5840-1 does not provide requirements specific to homografts, tissue engineered heart valves (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices. Some of the provisions of ISO 5840-1 can be applied to valves made from human tissue that is rendered non-viable.
NOTE A rationale for the provisions of ISO 5840-1 is given in Annex A.
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 1: Allgemeine Anforderungen (ISO 5840-1:2021)
Dieses Dokument ist auf Herzklappenersatz anwendbar, der für die Implantation in den Körper vorgesehen ist, und enthält allgemeine Anforderungen. Spezifische Anforderungen werden in den anderen Teilen der Normenreihe ISO 5840 festgelegt.
Dieses Dokument gilt für neu entwickelten und veränderten Herzklappenersatz; die Zubehörteile, Verpackung und Kennzeichnung, die für die Implantation erforderlich sind; und die Bestimmung der geeigneten Größe des zu implantierenden Herzklappenersatzes.
ISO 5840-1 umreißt eine Herangehensweise zur Überprüfung/Validierung des Designs und der Herstellung eines Herzklappenersatzes auf der Grundlage des Risikomanagements. Die Auswahl der geeigneten Qualifi¬kationsprüfungen und verfahren leitet sich aus der Risikobeurteilung ab. 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 und die klinische Bewertung des fertigen Herzklappenersatzes einschließen.
ISO 5840-1 legt Betriebsbedingungen für Herzklappenersatz fest.
ISO 5840 1 definiert darüber hinaus Begriffe, die auch für ISO 5840 2 und ISO 5840 3 gelten.
ISO 5840-1 stellt keine Anforderungen, die für Homografte, gewebetechnologisch hergestellte Herzklappen (z. B. Herzklappen, die In vivo regenerieren sollen) und Herzklappenersatz, der für die Implantation in Kreislaufunterstützungssystemen ausgelegt ist, spezifisch sind. Einige der Regelungen von ISO 5840-1 können auf aus abgetötetem menschlichen Gewebe hergestellten Klappen angewendet werden.
ANMERKUNG Eine Begründung für die Festlegungen von ISO 5840-1 wird in Anhang A gegeben.
Implants cardiovasculaires - Prothèses valvulaires - Partie 1: Exigences générales (ISO 5840-1:2021)
Le présent document s'applique aux prothèses valvulaires destinées à une implantation chez l'homme et établit des exigences générales. Les exigences spécifiques figurent dans les parties qui succèdent à la présente partie de l'ISO 5840.
Le présent document s'applique aux prothèses valvulaires récemment mises au point et aux prothèses valvulaires 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 à implanter.
L'ISO 5840-1 présente une approche pour la vérification/validation de la conception et la fabrication d'une prothèse valvulaire à travers la gestion des risques. La sélection des méthodes et des essais de qualification 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.
L'ISO 5840-1 définit les conditions de fonctionnement des prothèses valvulaires.
En outre, l'ISO 5840-1 définit les termes qui sont aussi applicable à l'ISO 5840-2 et l'ISO 5840-3.
L'ISO 5840-1 ne contient pas d'exigences spécifiques aux homogreffes, aux valves cardiaques issues de l'ingénierie tissulaire (par exemple, valves conçues pour se régénérer in vivo), ni aux prothèses valvulaires conçues pour une implantation dans des dispositifs d'assistance circulatoire. Certaines dispositions de l'ISO 5840-1 peuvent s'appliquer à des valves réalisées à partir de tissus humains rendus non viables.
NOTE Une justification des dispositions de l'ISO 5840-1 est donnée à l'Annexe A.
Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 1. del: Splošne zahteve (ISO 5840-1:2021)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2021
Nadomešča:
SIST EN ISO 5840-1:2015
Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 1. del: Splošne
zahteve (ISO 5840-1:2021)
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO
5840-1:2021)
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 1: Allgemeine Anforderungen
(ISO 5840-1:2021)
Implants cardiovasculaires - Prothèses valvulaires - Partie 1: Exigences générales (ISO
5840-1:2021)
Ta slovenski standard je istoveten z: EN ISO 5840-1:2021
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 5840-1
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2021
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 5840-1:2015
English Version
Cardiovascular implants - Cardiac valve prostheses - Part
1: General requirements (ISO 5840-1:2021)
Implants cardiovasculaires - Prothèses valvulaires - Herz- und Gefäßimplantate - Herzklappenprothesen -
Partie 1: Exigences générales (ISO 5840-1:2021) Teil 1: Allgemeine Anforderungen (ISO 5840-1:2021)
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 5840-1:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 5840-1:2021) 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 5840-1:2015.
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 5840-1:2021 has been approved by CEN as EN ISO 5840-1:2021 without any
modification.
INTERNATIONAL ISO
STANDARD 5840-1
Second edition
2021-01
Cardiovascular implants — Cardiac
valve prostheses —
Part 1:
General requirements
Implants cardiovasculaires — Prothèses valvulaires —
Partie 1: Exigences générales
Reference number
ISO 5840-1:2021(E)
©
ISO 2021
ISO 5840-1:2021(E)
© 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
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Published in Switzerland
ii © ISO 2021 – All rights reserved
ISO 5840-1:2021(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Abbreviations.15
5 Fundamental requirements .15
6 Device description .16
6.1 General .16
6.2 Intended use .16
6.3 Design inputs .16
6.3.1 Operational specifications .16
6.3.2 Performance specifications .17
6.3.3 Implant procedure.17
6.3.4 Packaging, labelling, and sterilization .17
6.4 Design outputs .18
6.5 Design transfer (manufacturing verification/validation) .18
6.6 Risk management .18
7 Design verification and validation .18
7.1 General requirements .18
7.2 In vitro assessment .18
7.2.1 General.18
7.2.2 Test conditions, sample selection and reporting requirements .19
7.2.3 Material property assessment .20
7.2.4 Hydrodynamic performance assessment .21
7.2.5 Structural performance assessment .21
7.2.6 Design- or procedure-specific testing.23
7.2.7 Device MRI compatibility .23
7.2.8 Simulated use.23
7.2.9 Human factors/usability assessment .23
7.2.10 Implant thrombogenic and haemolytic potential assessment .23
7.3 Preclinical in vivo evaluation .24
7.4 Clinical investigations .24
Annex A (informative) Rationale for the provisions of ISO 5840-1 .25
Annex B (normative) Packaging .28
Annex C (normative) Product labels, instructions for use, and training .29
Annex D (normative) Sterilization .32
Annex E (normative) In vitro test guidelines for paediatric devices .33
Annex F (informative) Corrosion assessment .37
Annex G (informative) Echocardiographic protocol .40
Annex H (informative) Assessment of implant thrombogenic and haemolytic potential .42
Annex I (informative) Guidelines for hydrodynamic performance characterization by
steady flow testing .53
Annex J (normative) Durability testing.60
Annex K (informative) Fatigue assessment .68
Annex L (normative) Clinical investigation endpoints for heart valve replacement devices .73
ISO 5840-1:2021(E)
Bibliography .76
iv © ISO 2021 – All rights reserved
ISO 5840-1:2021(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
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