EN ISO 5840-3:2013

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)

ISO 5840-3:2013 outlines 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 may 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 5840-3:2013 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
ISO 5840-3:2013 is applicable to all devices intended for implantation in human hearts as a transcatheter heart valve substitute.
ISO 5840-3:2013 is applicable to both newly developed and modified 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.

Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 3: Durch minimal-invasive Methoden implantierter Herzklappenersatz (ISO 5840-3:2013)

Dieser Teil von ISO 5840 umreißt eine Herangehensweise zur Überprüfung/Validierung des Designs und der Herstellung eines Transkatheter-Herzklappenersatzes auf der Grundlage des Risikomanagements. Die Auswahl der geeigneten Prüfungen und Verfahren der Überprüfung/Validierung muss sich aus der Risikobeurteilung 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 präklinische In-vivo- und die klinische Bewertung des fertigen Herzklappenersatzes einschließen.
Dieser Teil von ISO 5840 legt Betriebsbedingungen und Leistungskriterien für Transkatheter-Herzklappenersatz fest, sofern angemessene wissenschaftliche und/oder klinische Nachweise für deren Begründung vorliegen.
Dieser Teil von ISO 5840 ist auf alle Medizinprodukte anwendbar, die für die Implantation im menschlichen Herzen als Transkatheter-Herzklappenersatz vorgesehen sind.
Dieser Teil von ISO 5840 ist sowohl auf neu entwickelten als auch auf veränderten Transkatheter-Herzklappenersatz und dessen Zubehörteile anwendbar, sie gilt darüber hinaus für die Verpackung und die für die Implantation und Bestimmung der geeigneten Größe des zu implantierenden Herzklappenersatzes erforderliche Kenn¬zeichnung.
Dieser Teil von ISO 5840 schließt Herzklappenersatz aus, der für die Implantation in künstlichen Herzen oder herzunterstützenden Geräten ausgelegt ist.
In diesem Teil von ISO 5840 sind Anforderungen an Klappe-in-Klappe-Konfigurationen sowie Homografte nicht spezifisch festgelegt.  
In diesem Teil von ISO 5840 wird nicht-herkömmlicher chirurgisch implantierter Herzklappenersatz (z.B. nahtlos) nicht speziell angesprochen. Bei diesen Geräten könnten die Anforderungen sowohl dieser Norm als auch ISO 5840:2005 von Bedeutung sein und sollten berücksichtigt werden.   
ANMERKUNG   Eine Begründung für die Festlegungen dieses Teils von ISO 5840 wird in Anhang A gegeben.

Implants cardiovasculaires - Prothèses valvulaires - Partie 3: Valves cardiaques de substitution implantées par des techniques transcathéter (ISO 5840-3:2013)

L'ISO 5840-3:2013 présente une approche pour la vérification/validation de la conception et la fabrication d'une prothèse valvulaire implantée par transcathéter à travers la gestion des risques. La sélection des méthodes et des essais de vérification/validation appropriés se fait à partir de l'appréciation du risque. Les essais peuvent inclure les essais destinés à évaluer les propriétés physiques, chimiques, biologiques et mécaniques des prothèses valvulaires ainsi que 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 5840-3:2013 définit les conditions de fonctionnement et les exigences de performances relatives aux prothèses valvulaires implantées par transcathéter lorsqu'une preuve scientifique et/ou clinique adéquate existe pour les justifier.
L'ISO 5840-3:2013 s'applique à tous les dispositifs destinés à être implantés dans le c?ur humain, comme les prothèses valvulaires implantées par transcathéter.
L'ISO 5840-3:2013 s'applique à la fois aux prothèses valvulaires implantées par transcathéter récemment mises au point qu'à celles modifiées ainsi qu'aux dispositifs accessoires, à l'emballage et à l'étiquetage exigés pour leur implantation et pour la détermination de la taille appropriée de la prothèse valvulaire à implanter.

Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 3. del: Nadomestki srčne zaklopke, vsajeni (implantirani) s transkatetersko metodo (ISO 5840-3:2013)

Ta del standarda ISO 5840 določa pristop za preverjanje/potrjevanje oblike in izdelave transkatetrsko vsajenega nadomestka srčne zaklopke v skladu z obvladovanjem tveganj. Izbor ustreznih preskusov in metod preverjanja/potrjevanja se izpelje iz ocene tveganja. Preskusi lahko vključujejo preskuse za oceno fizikalnih, kemijskih, bioloških in mehanskih lastnosti nadomestkov srčne zaklopke ter drugih materialov in sestavin. Preskusi lahko vključujejo tudi preskuse za predklinično oceno in vivo ter klinično oceno končanega nadomestka srčne zaklopke. Ta del standarda ISO 5840 določa operativne pogoje in zahteve zmogljivosti za transkatetrsko vsajene nadomestke srčne zaklopke, če obstajajo ustrezni znanstveni in/ali klinični dokazi za njihovo upravičenost. Ta del standarda ISO 5840 velja za vse naprave, namenjene vsaditvi v človeško srce kot transkatetrsko vsajeni nadomestek srčne zaklopke. Ta del standarda ISO 5840 velja tako za na novo razvite in modificirane transkatetrsko vsajene nadomestke srčne zaklopke kot tudi za dodatne naprave, zahteve glede pakiranja in označevanja za vsaditev ter določanje ustrezne velikosti nadomestka srčne zaklopke za vsaditev. Ta del standarda ISO 5840 izključuje nadomestke srčnih zaklopk, namenjene vsaditvi v umetno srce ali napravo za podporo delovanja srca. Ta del standarda ISO 5840 izključuje konfiguracije zaklopke v zaklopki in homografte. Ta del standarda ISO 5840 ne obravnava posebej nadomestkov srčne zaklopke, ki niso vsajeni v skladu s tradicionalnimi metodami kirurške vsaditve (npr. brezšivno). Za te naprave so zahteve tega dela standardov ISO 5840 in ISO 5840:2005 lahko veljavne in se lahko upoštevajo.

General Information

• Status: Withdrawn
• Publication Date: 05-Mar-2013
• Withdrawal Date: 02-Feb-2021
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285 - Non-active surgical implants
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 03-Feb-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 5840-3:2013 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)

Relations

• Replaced By: EN ISO 5840-3:2021 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021)
• Effective Date: 09-Feb-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2013
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SIST EN ISO 5840:2006
9VDGNLLPSODQWDWL]DVUFHLQRåLOMH3URWH]H]DVUþQR]DNORSNRGHO
1DGRPHVWNLVUþQH]DNORSNHYVDMHQLLPSODQWLUDQLVWUDQVNDWHWHUVNRPHWRGR,62

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes
implanted by transcatheter techniques (ISO 5840-3:2013)
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 3: Durch minimal-invasive
Methoden implantierter Herzklappenersatz (ISO 5840-3:2013)
Implants cardiovasculaires - Prothèses valvulaires - Partie 3: Valves cardiaques de
substitution implantées par des techniques transcathéter (ISO 5840-3:2013)
Ta slovenski standard je istoveten z: EN ISO 5840-3:2013
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.

EUROPEAN STANDARD
EN ISO 5840-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2013
ICS 11.040.40
English Version
Cardiovascular implants - Cardiac valve prostheses - Part 3:
Heart valve substitutes implanted by transcatheter techniques
(ISO 5840-3:2013)
Implants cardiovasculaires - Prothèses valvulaires - Partie Herz- und Gefäßimplantate - Herzklappenprothesen - Teil
3: Valves cardiaques de substitution implantées par des 3: Durch minimal-invasive Methoden implantierter
techniques transcathéter (ISO 5840-3:2013) Herzklappenersatz (ISO 5840-3:2013)
This European Standard was approved by CEN on 21 January 2013.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5840-3:2013: E
worldwide for CEN national Members.

Contents Page
Foreword . 3
Annex ZA (informative)  Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC . 4

Foreword
This document (EN ISO 5840-3:2013) 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 September 2013, and conflicting national standards shall be
withdrawn at the latest by September 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
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, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
Endorsement notice
The text of ISO 5840-3:2013 has been approved by CEN as EN ISO 5840-3:2013 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC, Medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA
regulations.
Table — ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
European Standard of Directive 93/42/EEC

Annex C 7.2
7.2.2, 7.2.3 and 7.2.10 7.3
7.2.2.2 8.2
6.2.2.3 d), 6.4 and Annex C 8.3

6.2.4 and Annex E 8.4
6.4 8.5
6.2.2.3 c) and 7.2.5.2 9.2, 3rd indent

6.2.2.1 e) and 7.2.4 9.2, 4th indent
D.1.3 13.1 For labelling requirements consider
also ISO 14630:—, 11.2.
D.1.2 b) 13.3 a)
D.1.1 d), D.1.2 e) and f ) 13.3 b)

D.1.1 e) and D.1.2 g) 13.3 c)
D.1.1 c) and D.1.2 d) 13.3 d)
D.1.1 f ) and D.1.2 h) 13.3 e)

D.1.1 g) and D.1.2 i) 13.3 f )

D.1.2 j) 13.3 h)
D.1.2 k) 13.3 i)
D.1.2 l) 13.3 k)
D.1.1 e) and D.1.2 g) 13.3 m)
D.1.3 a), b), d), i), k), l) and m) 13.6 a)
Table
(continued)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
European Standard of Directive 93/42/EEC

D.1.3 e) and u) 13.6 b)
D.1.3 g) 13.6 c)
D.1.3 p) 13.6 f )
D.1.3 n) 13.6 g)
D.1.3 r) 13.6 i)
D.1.3 p) 13.6 n)
D.1.3 c) 13.6 q)
WARNING — Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.

INTERNATIONAL ISO
STANDARD 5840-3
First edition
2013-03-01
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 5840-3:2013(E)
©
ISO 2013
ISO 5840-3:2013(E)
© ISO 2013
All rights reserved. Unless otherwise specified, 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
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Tel. + 41 22 749 01 11
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Published in Switzerland
ii © ISO 2013 – All rights reserved

ISO 5840-3:2013(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Abbreviations.10
5 Fundamental requirements .10
6 Device description .10
6.1 Intended use .10
6.2 Design inputs .10
6.3 Design outputs .13
6.4 Design transfer (manufacturing verification/validation) .13
6.5 Risk management .14
7 Design verification testing and analysis/design validation .14
7.1 General requirements .14
7.2 In vitro assessment .14
7.3 Preclinical in vivo evaluation .23
7.4 Clinical investigations .26
Annex A (informative) Rationale for the provisions of this part of ISO 5840 .31
Annex B (informative) Examples of transcatheter heart valve substitutes, components and
delivery systems .34
Annex C (normative) Packaging .40
Annex D (normative) Product labels, instructions for use and training .41
Annex E (normative) Sterilization .44
Annex F (informative) Valve description .45
Annex G (informative) Transcatheter heart valve substitute hazards, associated failure modes and
evaluation methods .47
Annex H (informative) In vitro test guidelines for paediatric devices .51
Annex I (informative) Statistical procedures when using performance criteria .55
Annex J (informative) Examples and definitions of some physical and material properties of
transcatheter heart valve substitutes and their components .56
Annex K (informative) Examples of standards applicable to testing of materials and components
of transcatheter heart valve substitutes .
...