SIST EN ISO 5840-3:2013

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

This part of ISO 5840 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. This part of ISO 5840 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. This part of ISO 5840 is applicable to all devices intended for implantation in human hearts as a transcatheter heart valve substitute. This part of ISO 5840 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. This part of ISO 5840 excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices. This part of ISO 5840 excludes valve-in-valve configurations and homografts. This part of ISO 5840 does not specifically address non-traditional surgically implanted heart valve substitutes (e.g. sutureless). For these devices, the requirements of both this part of ISO 5840 and ISO 5840:2005 might be relevant and can be considered.

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
• Public Enquiry End Date: 14-Jul-2011
• Publication Date: 21-May-2013
• Withdrawal Date: 17-Feb-2021
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 17-Feb-2021
• Due Date: 12-Mar-2021
• Completion Date: 18-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: EN ISO 5840-3:2013 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)

Relations

• Replaces: SIST EN ISO 5840:2006 - Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
• Effective Date: 01-Jun-2013
• Replaced By: SIST 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: 01-Mar-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 5840-3:2013
01-junij-2013
1DGRPHãþD
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
SIST EN ISO 5840-3:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 5840-3:2013

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SIST EN ISO 5840-3:2013


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.

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SIST EN ISO 5840-3:2013
EN ISO 5840-3:2013 (E)
Contents Page
Foreword . 3
Annex ZA (informative)  Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC . 4

2

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SIST EN ISO 5840-3:2013
EN ISO 5840-3:2013 (E)
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.
3

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SIST EN ISO 5840-3:2013
EN ISO 5840-3:2013 (E)
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)
4

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SIST EN ISO 5840-3:2013
EN ISO 5840-3:2013 (E)

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.

5

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SIST EN ISO 5840-3:2013

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SIST EN ISO 5840-3:2013
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

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SIST EN ISO 5840-3:2013
ISO 5840-3:2013(E)

COPYRIGHT PROTECTED DOCUMENT
© 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved

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SIST EN ISO 5840-3:2013
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 .69
Annex L (informative) Raw and post-conditioning mechanical properties for support
structure materials .75
Annex M (informative) Corrosion assessment .77
Annex N (informative) Guidelines for verification of hydrodynamic performance.80
Annex O (informative) Durability testing .84
Annex P (informative) Fatigue assessment .86
Annex Q (informative) Preclinical in vivo evaluation .92
Annex R (normative) Adverse event classification during clinical investigation .95
Annex S (informative) Echocardiographic protocol .100
© ISO 2013 – All rights reserved iii

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SIST EN ISO 5840-3:2013
ISO 5840-3:2013(E)

Bibliography .103
iv © ISO 2013 – All rights reserved

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SIST EN ISO 5840-3:2013
ISO 5840-3:2013(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
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.
ISO 5840-3 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
ISO 5840 consists of the following parts, under the general title Cardiovascular implants — Cardiac
valve prostheses:
— Part 3: Heart valve substitutes implanted by minimally invasive techniques
© ISO 2013 – All rights reserved v

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SIST EN ISO 5840-3:2013
ISO 5840-3:2013(E)

Introduction
No heart valve substitute is ideal. Therefore, a group of engineers, scientists and clinicians well aware
of the problems associated with heart valve substitutes and their development has prepared this part
of ISO 5840. In several areas, the provisions of this part of ISO 5840 have been deliberately left partially
defined so as not to inhibit development and innovation. This part of ISO 5840 specifies types of tests,
test methods and requirements for test apparatus. It requires documentation of test methods and
results. This part of ISO 5840 deals with those areas that will ensure adequate mitigation of device-
associated risks for patients and other users of the device, facilitate quality assurance, aid the cardiac
surgeon and cardiologist in choosing a heart valve substitute, and ensure that the device will be
presented in a convenient form. This part of ISO 5840 emphasizes the need to specify types of in vitro
testing, preclinical in vivo and clinical evaluations as well as to report all in vitro, preclinical in vivo and
clinical evaluations. It describes the labels and packaging of the device. Such a process involving in vitro,
preclinical in vivo and clinical evaluations is intended to clarify the required procedures prior to market
release and to enable prompt identification and management of any subsequent problems.
With regard to in vitro testing and reporting, apart from basic material testing for mechanical, physical,
chemical and biocompatibility characteristics, this part of ISO 5840 also covers important hydrodynamic
and durability characteristics of transcatheter heart valve substitutes and their delivery systems. This
part of ISO 5840 does not specify exact test methods for hydrodynamic and durability testing but it
offers guidelines for the test apparatus.
This part of ISO 5840 should be revised, updated and amended as knowledge and techniques in heart
valve substitute technology improve.
This part of ISO 5840 is to be used in conjunction with ISO 5840:2005, which will be replaced by
ISO 5840-1 in future.
vi © ISO 2013 – All rights reserved

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SIST EN ISO 5840-3:2013
INTERNATIONAL STANDARD ISO 5840-3:2013(E)
Cardiovascular implants — Cardiac valve prostheses —
Part 3:
Heart valve substitutes implanted by transcatheter
techniques
1 Scope
This part of ISO 5840 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.
This part of ISO 5840 defines operational conditions and performance requirements for transcatheter
heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
This part of ISO 5840 is applicable to all devices intended for implantation in human hearts as a
transcatheter heart valve substitute.
This part of ISO 5840 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.
This part of ISO 5840 excludes heart valve substitutes designed for implantation in artificial hearts or
heart assist devices.
This part of ISO 5840 excludes valve-in-valve configurations and homografts.
This part of ISO 5840 does not specifically address non-traditional surgically implanted heart valve
substitutes (e.g. sutureless). For these devices, the requirements of both this part of ISO 5840 and
ISO 5840:2005 might be relevant and can be considered.
NOTE A rationale for the provisions of this part of ISO 5840 is given in Annex A.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-2, Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO/TS 11135-2, Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application
of ISO 11135-1
© ISO 2013 – All rights reserved 1

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SIST EN ISO 5840-3:2013
ISO 5840-3:2013(E)

ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11137-3, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14160, Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical
devices utilizing animal tissues and their derivatives — Requirements for characterization, development,
validation and routine control of a sterilization process for medical devices
ISO 14630:2012, Non-active surgical implants — General requirements
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 22442-1, Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk
management
ISO 22442-2, Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing,
collection and handling
ISO 22442-3, Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the
elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
IEC 62366, Medical devices — Application of usability engineering to medical devices
ASTM F2052, Standard test method for measurement of magnetically induced displacement force on medical
devices in the magnetic resonance environment
ASTM F2503, Standard practice for marking medical devices and other items for safety in the magnetic
resonance environment
ASTM F2213, Standard test method for measurement of magnetically induced torque on medical devices in
the magnetic resonance environment
ASTM F2182, Standard test method for measurement of radio frequency induced heating near passive
implants during magnetic resonance imaging
ASTM F2119, Standard test method for evaluation of MR image artifacts from passive implants
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE Additional definitions can be found in the informative annexes.
2 © ISO 2013 – All rights reserved

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SIST EN ISO 5840-3:2013
ISO 5840-3:2013(E)

3.1
accessories
device-specific tools that are required to assist in the implantation of the transcatheter heart valve substitute
3.2
adverse event
AE
untoward medical occurrence in a study subject which does not necessarily have to have a causal
relationship with study treatment
Note 1 to entry: An AE can be an unfavourable and unintended sign (including an abnormal laboratory finding), symptom
or disease, temporary or permanent, whether or not related to the prosthetic valve implantation or procedure.
3.3
arterial end diastolic pressure
minimum value of the arterial pressure during diastole
3.4
arterial peak systolic pressure
maximum value of the arterial pressure during systole
3.5
back pressure
differential pressure applied across the valve during the closed phase
3.6
body surface area
A
bs
2
total surface area (m ) of the human body
Note 1 to entry: This can be calculated (Mosteller’s formula) as the square root of product of the weight in kg
[12]
times the height in cm divided by 3 600 (see Reference ).
3.7
cardiac index
2 2
cardiac output (CO, l/min) divided by the body surface area (A , m ), in units l/min/m
bs
3.8
closing volume
portion of the regurgitant volume that is associated with the dynamics of the valve closure during
a single cycle
Note 1 to entry: See Figure 1.
© ISO 2013 – All rights reserved 3

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SIST EN ISO 5840-3:2013
ISO 5840-3:2013(E)

Key
X time
Y flowrate
1 closing volume
2 leakage volume
Figure 1 — Schematic representation of flow waveform and regurgitant volumes for one cycle
3.9
coating
thin-film material that is applied to an element of a heart valve substitute to modify its physical or
chemical properties
3.10
compliance
relationship between change in diameter and change in pressure of a deformable tubular structure (e.g.
valve annulus, aorta, conduit), defined in this part of ISO 5840 as
()rr−×100
21
C =×100%
rp×−()p
12 1
where
C is the compliance in units of % radial change/100 mmHg;
p is the diastolic pressure, in mmHg;
1
p is the systolic pressure, in mmHg;
2
r is the inner radius at p , in millimetres;
1 1
r is the inner radius at p , in millimetres.
2 2
Note 1 to entry: See ISO 25539-1.
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SIST EN ISO 5840-3:2013
ISO 5840-3:2013(E)

3.11
component-joining material
material, such as a suture, adhesive or welding compound, used to assemble the components of a heart
valve substitute, thereby becoming part of the implant device
Note 1 to entry: See examples in Annex B.
3.12
cycle
one complete sequence in the action of a heart valve substitute under pulsatile flow conditions
3.13
cycle rate
number of complete cycles per unit of time, usually expressed as cycles per minute (cycles/min)
3.14
delivery approach
anatom
...