SIST EN ISO 5840-2:2015
(Main)Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
This part of ISO 5840 is applicable to heart valve substitutes intended for implantation in human hearts,
generally requiring cardiopulmonary bypass and generally with direct visualization.
This part of ISO 5840 is applicable to both newly developed and modified surgical heart valve substitutes
and to the accessories, packaging, and labelling required for their implantation and for determining the
appropriate size of the surgical heart valve substitute to be implanted.
This part of ISO 5840 outlines an approach for qualifying 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 may include those to assess the physical, chemical,
biological, and mechanical properties of surgical heart valve substitutes and of their materials and
components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation
of the finished surgical heart valve substitute.
This part of ISO 5840 defines performance requirements for surgical heart valve substitutes where
adequate scientific and/or clinical evidence exists for their justification.
For novel surgical heart valve substitutes, e.g. sutureless, the requirements of both this International
Standard and ISO 5840-3 might be relevant and shall be considered as applicable to the specific device
design and shall be based on the results of the risk analysis.
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 homografts.
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter Herzklappenersatz (ISO 5840-2:2015)
Implants cardiovasculaires - Prothèses valvulaires - Partie 2: Prothèse valvulaires implantées chirurgicalement (ISO 5840-2:2015)
ISO 5840-2:2015 s'applique aux prothèses valvulaires destinées à être implantées dans le c?ur humain et nécessitant en général une circulation extra-corporelle et une visualisation directe.
ISO 5840-2:2015 s'applique à la fois aux prothèses valvulaires chirurgicales récemment mises au point et aux prothèses valvulaires chirurgicales modifiées ainsi qu'aux accessoires, à l'emballage et à l'étiquetage exigés pour leur implantation et pour la détermination de la taille appropriée de la prothèse valvulaire chirurgicale à implanter.
ISO 5840-2:2015 présente une approche pour la qualification de la conception et de la fabrication d'une prothèse valvulaire chirurgicale 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. Les essais peuvent inclure les essais destinés à évaluer les propriétés physiques, chimiques, biologiques et mécaniques des prothèses valvulaires chirurgicales ainsi que 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.
ISO 5840-2:2015 définit les exigences de performances relatives aux prothèses valvulaires chirurgicales lorsqu'une preuve scientifique et/ou clinique adéquate existe pour les justifier.
Pour les nouvelles prothèses valvulaires chirurgicales (par exemple, les prothèses sans suture), les exigences de la présente Norme internationale et de l'ISO 5840‑3 peuvent être pertinentes. Elles doivent être considérées comme applicables à la conception spécifique du dispositif et s'appuyer sur les résultats de l'analyse des risques.
ISO 5840-2:2015 exclut les prothèses valvulaires destinées à être implantées dans les c?urs artificiels ou dans des dispositifs d'assistance cardiaque.
ISO 5840-2:2015 ne couvre pas les allogreffes.
Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 2. del: Kirurško vsajeni (implantirani) nadomestki srčne zaklopke (ISO 5840-2:2015)
Ta del standarda ISO 5840 velja za nadomestke srčne zaklopke, namenjene vsaditvi v človeško srce, ki navadno potrebujejo kardiopulmonalni obvod z neposredno vizualizacijo.
Ta del standarda ISO 5840 velja tako za na novo razvite in modificirane kirurške 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 določa pristop za potrjevanje oblike in izdelave kirurškega nadomestka srčne zaklopke v skladu z obvladovanjem tveganj. Izbor ustreznih preskusov in metod za potrjevanje se izpelje iz ocene tveganja. Preskusi lahko vključujejo preskuse za oceno fizikalnih, kemičnih, bioloških in mehanskih lastnosti kirurških nadomestkov srčne zaklopke ter drugih materialov in sestavin. Preskusi lahko vključujejo tudi preskuse za predklinično oceno in vivo ter klinično oceno končanega kirurškega nadomestka srčne zaklopke.
Ta del standarda ISO 5840 opredeljuje obratovalne pogoje kirurških nadomestkov srčne zaklopke,
če je to potrebno na podlagi znanstvenih in/ali kliničnih dokazov.
Zahteve iz tega mednarodnega standarda kot tudi iz standarda ISO 5840-3 so morda relevantne za nove kirurške nadomestke srčne zaklopke, npr. brezšivne, veljajo za določene oblike naprav in morajo temeljiti na rezultatih ocene analize tveganja.
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 homografte.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 5840-2:2015
01-december-2015
1DGRPHãþD
SIST EN ISO 5840:2009
9VDGNL LPSODQWDWL ]DVUFHLQRåLOMH3URWH]H]DVUþQR]DNORSNRGHO .LUXUãNR
YVDMHQL LPSODQWLUDQL QDGRPHVWNLVUþQH]DNORSNH ,62
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart
valve substitutes (ISO 5840-2:2015)
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter
Herzklappenersatz (ISO 5840-2:2015)
Implants cardiovasculaires - Prothèses valvulaires - Partie 2: Prothèse valvulaires
implantées chirurgicalement (ISO 5840-2:2015)
Ta slovenski standard je istoveten z: EN ISO 5840-2:2015
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 5840-2:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 5840-2:2015
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SIST EN ISO 5840-2:2015
EN ISO 5840-2
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2015
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 5840:2009
English Version
Cardiovascular implants - Cardiac valve prostheses - Part
2: Surgically implanted heart valve substitutes (ISO 5840-
2:2015)
Implants cardiovasculaires - Prothèses valvulaires - Herz- und Gefäßimplantate - Herzklappenprothesen -
Partie 2: Prothèse valvulaires implantées Teil 2: Chirurgisch implantierter Herzklappenersatz
chirurgicalement (ISO 5840-2:2015) (ISO 5840-2:2015)
This European Standard was approved by CEN on 24 July 2015.
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
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5840-2:2015 E
worldwide for CEN national Members.
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SIST EN ISO 5840-2:2015
EN ISO 5840-2:2015 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices . 4
2
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SIST EN ISO 5840-2:2015
EN ISO 5840-2:2015 (E)
European foreword
This document (EN ISO 5840-2:2015) 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 March 2016, and conflicting national standards shall
be withdrawn at the latest by September 2018.
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 supersedes EN ISO 5840:2009.
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 5840-2:2015 has been approved by CEN as EN ISO 5840-2:2015 without any
modification.
3
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SIST EN ISO 5840-2:2015
EN ISO 5840-2:2015 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to Essential
Requirements of the New Approach Directive 93/42/EEC on 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 on medical devices
Clause(s)/sub-clause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this European Standard of Directive 93/42/EEC
Clause 5, 6.1, 6.2.1, 6.2.2, 6.4 7.1
6.2, 6.2.3, 6.4, 7.2.2.2 7.2
6.2, 6.4 7.3
6.2, 6.4, 6.5, 7.2.2.2 7.5
6.2.2, 6.4, 6.5 7.6
6.2, 6.4, 6.5 8.1
6.5, 7.2.2.2 8.2
6.2.3 8.3
6.2.3 8.4
6.4 8.5
6.2.3 8.6
6.2.3 8.7
6.3, 6.2.3 9.1
6.2.1, 6.2.2, 6.4, 6.5 9.2
6.2.3, 6.3 13
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
4
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SIST EN ISO 5840-2:2015
INTERNATIONAL ISO
STANDARD 5840-2
First edition
2015-09-15
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 5840-2:2015(E)
©
ISO 2015
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SIST EN ISO 5840-2:2015
ISO 5840-2:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
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SIST EN ISO 5840-2:2015
ISO 5840-2:2015(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Abbreviations. 4
5 Fundamental requirements . 4
6 Device description . 5
6.1 Intended use . 5
6.2 Design inputs . 5
6.2.1 Operational specifications . 5
6.2.2 Performance specifications . 5
6.2.3 Packaging, labelling, and sterilization . 6
6.3 Design outputs . 6
6.3.1 General. 6
6.4 Design transfer (manufacturing qualification) . 6
6.5 Risk management . 6
7 Design verification testing and analysis/design validation . 6
7.1 General requirements . 6
7.2 In vitro assessment . 7
7.2.1 Test conditions, sample selection, and reporting requirements . 7
7.2.2 Material property assessment . 8
7.2.3 Hydrodynamic performance assessment . 8
7.2.4 Structural performance assessment .10
7.2.5 Device MRI safety .11
7.2.6 Additional implant design evaluation requirements .11
7.2.7 Design specific testing .12
7.2.8 Simulated use.12
7.2.9 Human factors/usability assessment .12
7.3 Preclinical in vivo evaluation .12
7.3.1 Overall requirements .12
7.3.2 Methods .13
7.3.3 Test report .14
7.4 Clinical investigation .15
7.4.1 General.15
7.4.2 Statistical considerations .15
7.4.3 Distribution of subjects and investigators .15
7.4.4 Sample size .15
7.4.5 Entry criteria .16
7.4.6 Duration of the study .16
7.4.7 Clinical data requirements .16
7.4.8 Clinical investigation report .18
Annex A (informative) Heart valve substitute hazards, associated failure modes, and
evaluation methods .20
Annex B (informative) In vitro procedures for testing unstented or similar valves in
compliant chambers .23
Annex C (informative) Preclinical in vivo evaluation .25
Annex D (informative) Description of the surgical heart valve substitute.28
Annex E (informative) Examples of components of some surgical heart valve substitutes .30
© ISO 2015 – All rights reserved iii
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SIST EN ISO 5840-2:2015
ISO 5840-2:2015(E)
Annex F (informative) Guidelines for verification of hydrodynamic performance .34
Annex G (informative) Durability testing .43
Annex H (informative) Examples of design specific testing .45
Annex I (informative) Fatigue assessment .47
Annex J (normative) Methods of evaluating clinical data .53
Bibliography .54
iv © ISO 2015 – All rights reserved
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SIST EN ISO 5840-2:2015
ISO 5840-2:2015(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This first edition of ISO 5840-2, together with ISO 5840-1 and ISO 5840-3, cancels and replaces
ISO 5840:2005, which has been technically revised.
ISO 5840 consists of the following parts, under the general title Cardiovascular implants — Cardiac
valve prostheses:
— Part 1: General requirements
— Part 2: Surgically implanted heart valve substitutes
— Part 3: Heart valve substitutes implanted by transcatheter techniques
© ISO 2015 – All rights reserved v
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SIST EN ISO 5840-2:2015
ISO 5840-2:2015(E)
Introduction
This part of ISO 5840 has been prepared for surgical heart valve substitutes with emphasis on
specifying types of in vitro testing, preclinical in vivo and clinical evaluations, reporting of all in vitro,
preclinical in vivo, and clinical evaluations and labelling and packaging of the device. This process is
intended to clarify the required procedures prior to market release and to enable prompt identification
and management of any subsequent issues.
This part of ISO 5840 is to be used in conjunction with ISO 5840-1.
vi © ISO 2015 – All rights reserved
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SIST EN ISO 5840-2:2015
INTERNATIONAL STANDARD ISO 5840-2:2015(E)
Cardiovascular implants — Cardiac valve prostheses —
Part 2:
Surgically implanted heart valve substitutes
1 Scope
This part of ISO 5840 is applicable to heart valve substitutes intended for implantation in human hearts,
generally requiring cardiopulmonary bypass and generally with direct visualization.
This part of ISO 5840 is applicable to both newly developed and modified surgical heart valve substitutes
and to the accessories, packaging, and labelling required for their implantation and for determining the
appropriate size of the surgical heart valve substitute to be implanted.
This part of ISO 5840 outlines an approach for qualifying 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 may include those to assess the physical, chemical,
biological, and mechanical properties of surgical heart valve substitutes and of their materials and
components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation
of the finished surgical heart valve substitute.
This part of ISO 5840 defines performance requirements for surgical heart valve substitutes where
adequate scientific and/or clinical evidence exists for their justification.
For novel surgical heart valve substitutes, e.g. sutureless, the requirements of both this International
Standard and ISO 5840-3 might be relevant and shall be considered as applicable to the specific device
design and shall be based on the results of the risk analysis.
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 homografts.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 5840-1:2015, Cardiovascular implants and extracorporeal systems — Cardiac valve prostheses —
Part 1: General requirements
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 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14630, Non-active surgical implants — General requirements
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 16061, Instrumentation for use in association with non-active surgical implants – General requirements
© ISO 2015 – All rights reserved 1
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SIST EN ISO 5840-2:2015
ISO 5840-2:2015(E)
ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories
ISO 22442 (all parts), Medical devices utilizing animal tissues and their derivatives
ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on
Medical Devices in the Magnetic Resonance Environment
ASTM F2119, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
ASTM F2182, Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near
Passive Implants During Magnetic Resonance Imaging
ASTM F2213, Standard Test Method for Measurement of Magnetically Induced Torque 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
3 Terms and definitions
For the purposes of this document, the following terms and definitions given in ISO 5840-1 and the
following apply.
3.1
cycle rate
number of complete cycles per unit of time, usually expressed as cycles per minute (cycles/min)
3.2
internal orifice diameter
numerical indication of the minimum diameter within a surgical heart valve substitute through
which blood flows
Note 1 to entry: See Figure 1.
3.3
intra-annular sewing ring
sewing ring designed to secure the surgical heart valve wholly or mostly within the patient’s tissue
annulus
Note 1 to entry: See Figure 1.
Note 2 to entry: See also 3.2, 3.10, and 3.12.
2 © ISO 2015 – All rights reserved
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SIST EN ISO 5840-2:2015
ISO 5840-2:2015(E)
Key
1 internal orifice diameter
2 tissue annulus diameter
3 external sewing ring diameter
Figure 1 — Designation of dimensions of surgical heart valve substitute sewing ring
configurations
3.4
major bleeding
any episode of major internal or external bleeding that causes death, hospitalization, or permanent
injury (e.g. vision loss) or necessitates transfusion
3.5
major paravalvular leak
paravalvular leakage leading to death or re-intervention, or causing heart failure requiring additional
medication, or causing moderate or severe regurgitation or prosthesis ‘rocking’ on investigation even
in the apparent absence of symptoms, or causing hemolytic anemia
3.6
nonstructural valve dysfunction
abnormality extrinsic to the heart valve substitute that results in stenosis, regurgitation, and/or
haemolytic anemia
3.7
prosthetic valve endocarditis
any infection involving a valve in which an operation has been performed, based on reoperation,
autopsy or the Duke Criteria for Endocarditis
Note 1 to entry: See Reference [16].
3.8
structural valve deterioration
change in the function of a heart valve substitute resulting from an intrinsic abnormality that causes
stenosis or regurgitation
Note 1 to entry: This definition excludes infection or thrombosis of the heart valve substitute. It includes intrinsic
changes such as wear, fatigue failure, stress fracture, occluder escape, suture line disruption of components of
the prosthesis, calcification, cavitation erosion, leaflet tear, and stent creep.
© ISO 2015 – All rights reserved 3
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SIST EN ISO 5840-2:2015
ISO 5840-2:2015(E)
3.9
support structure
component of a heart valve substitute that houses the occluder(s)
EXAMPLE Stent, frame, housing.
3.10
supra-annular sewing ring
sewing ring designed to secure the valve wholly above the patient’s tissue annulus
Note 1 to entry: See Figure 1.
3.11
thromboembolism
any embolic event that occurs in the absence of infection after the immediate perioperative period and
may be manifested by a neurological event or a noncerebral embolic event
3.12
tissue annulus diameter
TAD
diameter in millimetres of the smallest flow area within the patient’s valve annulus
3.13
valve size
manufacturer’s designation of a surgical heart valve substitute which indicates the tissue annulus
diameter (TAD in millimetres) of the patient into whom the surgical heart valve substitute is intended
to be implanted (i.e. TAD = designated valve size)
Note 1 to entry: This takes into consideration the manufacturer’s recommended implant position relative to the
annulus and the suture technique.
3.14
valve thrombosis
any thrombus not caused by infection attached to or near an operated valve that occluded part of the
blood flow path, interferes with valve function, or is sufficiently large to warrant treatment
Note 1 to entry: See Reference [14].
4 Abbreviations
For the purposes of this document, the following abbreviations apply.
EOA Effective Orifice Area
CFD Computational Fluid Dynamics
FEA Finite Element Analysis
IFU Instructions For Use
OPC Objective Performance Criteria
5 Fundamental requirements
The manufacturer shall determine, at all stages of the product life cycle, the acceptability of the product
for clinical use.
4 © ISO 2015 – All rights reserved
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SIST EN ISO 5840-2:2015
ISO 5840-2:2015(E)
6 Device description
6.1 Intended use
The manufacturer shall identify the physiological condition(s) to be treated, the intended patient
population, potential adverse events, and intended claims.
6.2 Design inputs
6.2.1 Operational specifications
The manufacturer shall define the operational specifications for the device
...
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