SIST EN 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

• Status: Published
• Public Enquiry End Date: 19-Mar-2019
• Publication Date: 21-Feb-2021
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 11-Feb-2021
• Due Date: 18-Apr-2021
• Completion Date: 22-Feb-2021
• Ref Project: EN ISO 5840-1:2021 - Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021)

Relations

• Replaces: SIST EN ISO 5840-1:2015 - Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
• Effective Date: 01-Mar-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 5840-1:2021
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
SIST EN ISO 5840-1:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 5840-1:2021
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SIST EN ISO 5840-1:2021
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.
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SIST EN ISO 5840-1:2021
EN ISO 5840-1:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 5840-1:2021
EN ISO 5840-1:2021 (E)
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.
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SIST EN ISO 5840-1:2021
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SIST EN ISO 5840-1:2021
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
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SIST EN ISO 5840-1:2021
ISO 5840-1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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SIST EN ISO 5840-1:2021
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 2021 – All rights reserved iii
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SIST EN ISO 5840-1:2021
ISO 5840-1:2021(E)

Bibliography .............................................................................................................................................................................................................................76

iv © ISO 2021 – All rights reserved
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SIST EN ISO 5840-1:2021
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 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 of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee

SC 2, Cardiovascular implants and extracorporeal systems, in collaboration with the European Committee

for Standardization (CEN) Technical Committee CEN/TC 285, Non-active surgical implants, in accordance

with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This second edition cancels and replaces the first edition (ISO 5840-1:2015), which has been technically

revised.

The main changes compared to the previous edition are as follows: the engineering and clinical

requirements in the ISO 5840 series have been updated to current specifications and integrated and

harmonized across all parts.
A list of all parts in the ISO 5840 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2021 – All rights reserved v
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SIST EN ISO 5840-1:2021
ISO 5840-1:2021(E)
Introduction
There is, as yet, no heart valve substitute which can be regarded as ideal.

The ISO 5840 series has been prepared by a group well aware of the issues associated with heart valve

substitutes and their development. In several areas, the provisions of the ISO 5840 series deliberately

have not been specified to encourage development and innovation. It does specify the types of tests,

provides guidance for test methods and test apparatuses and requires documentation of test methods

and results. The areas with which the ISO 5840 series are concerned are those which ensure that

associated risks to the patient and other users of the device have been adequately mitigated, facilitate

quality assurance, aid the clinician in choosing a heart valve substitute, and ensure that the device

is presented in a convenient form. Emphasis has been placed 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 the labelling 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, the ISO 5840 series also covers important hydrodynamic

and durability characteristics of heart valve substitutes and systems required for their implantation.

The ISO 5840 series does not specify exact test methods for hydrodynamic and durability testing, but it

offers guidelines for the test apparatus.

The ISO 5840 series is intended to be revised, updated, and/or amended as knowledge and techniques

in heart valve substitute technology improve.
This document is used in conjunction with ISO 5840-2 and ISO 5840-3.
vi © ISO 2021 – All rights reserved
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SIST EN ISO 5840-1:2021
INTERNATIONAL STANDARD ISO 5840-1:2021(E)
Cardiovascular implants — Cardiac valve prostheses —
Part 1:
General requirements
1 Scope

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.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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 5840-2, Cardiovascular implants — Cardiac valve prostheses —Part 2: Surgically implanted heart valve

substitutes

ISO 5840-3, Cardiovascular implants — Cardiac valve prostheses —Part 3: Heart valve substitutes

implanted by transcatheter techniques

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process

ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,

validation and routine control of a sterilization process for medical devices
ISO 11137 (all parts), Sterilization of health care products — Radiation
ISO 11607 (all parts), Packaging for terminally sterilized medical devices

ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes

© ISO 2021 – All rights reserved 1
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SIST EN ISO 5840-1:2021
ISO 5840-1:2021(E)

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, 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 15223-1, Symbols to be used with medical device labels, labelling and information to be supplied —

Part 1: General requirements

ISO 22442 (all parts), Medical devices utilizing animal tissues and their derivatives

IEC 62366 (all parts), Medical Devices — Application of usability engineering to medical devices

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
accessory

device-specific tool that is required to assist in the implantation of the heart valve substitute (3.30)

3.2
adverse event

untoward medical occurrence in a study subject which does not necessarily 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 heart valve substitute (3.30) or

implantation procedure.
3.3
area-derived valve diameter

calculated valve diameter based on area (A) of the device [i.e. a “D-Shaped” transcatheter mitral valve

implantation (TMVI) device; refer to Figure 1]: D = 4 A/π

Note 1 to entry: This approach is typically used for labelling the sizes of TMVI devices where valves are designed

for a noncircular geometry.
2 © ISO 2021 – All rights reserved
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SIST EN ISO 5840-1:2021
ISO 5840-1:2021(E)
Key
1 area of valve
D = 4 A/π
D = area-derived diameter
Figure 1 — Area-derived valve diameter for a non-circular device
3.4
arterial end diastolic pressure
minimum value of the arterial pressure during diastole
3.5
arterial peak systolic pressure
maximum value of the arterial pressure during systole (3.68)
3.6
back pressure
differential pressure across the valve during the closed phase
3.7
body surface area
BSA
total surface area (m ) of the human body

Note 1 to entry: This can be calculated (Mosteller's formula) as the square root of the product of the weight in kg

and the height in cm divided by 3 600 (see Reference [26]).
3.8
cardiac output
stroke volume (3.64) times heart rate
3.9
closing volume

portion of the regurgitant volume (3.49) that is associated with the dynamics of valve closure during a

single cycle (3.13)
Note 1 to entry: See Figure 2.

Note 2 to entry: The volume of flow occurring between end of systole (3.23) and start of leakage (3.59) for aortic

and pulmonary positions; between end of diastole (3.21) and start of leakage for mitral and tricuspid positions.

3.10
coating

thin-film material that is applied to an element of a heart valve system (3.31) to modify its surface

physical or chemical properties
© ISO 2021 – All rights reserved 3
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SIST EN ISO 5840-1:2021
ISO 5840-1:2021(E)
3.11
compliance

relationship between change in diameter and change in pressure of a deformable tubular structure (e.g.

aorta, conduit) defined in ISO 5840 (all parts) as
()rr−×100
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;
p is the systolic pressure, in mmHg;
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.
Key
X time 1 closing volume
Y flowrate 2 leakage volume

NOTE The total regurgitant volume is the sum of the closing volume and the leakage volume.

Figure 2 — Schematic representation of flow waveform, regurgitant volumes, and end of

closure determination for one cycle
4 © ISO 2021 – All rights reserved
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SIST EN ISO 5840-1:2021
ISO 5840-1:2021(E)
3.12
control valve

heart valve substitute for preclinical and clinical evaluations of similar design and constructed of

similar material as the investigational device
Note 1 to entry: The control valve should have a known clinical history.
3.13
cycle

complete sequence in the action of a heart valve substitute (3.30) under pulsatile-flow conditions

3.14
cycle rate
beat rate

number of complete cycles (3.13) per unit of time usually expressed as cycles per minute (cycles/min or

beats/min [bpm])
3.15
design verification

establishment by objective evidence that the design output meets the design input requirements

3.16
design validation

establishment by objective evidence that device specifications conform with user needs and intended

use(s) (3.33)
3.17
device embolization

dislodgement from the intended and documented original position to an unintended and non-

therapeutic location
3.18
device failure
inability of a device to perform its intended function
3.19
diastole
diastolic duration
portion of cardiac cycle time corresponding to ventricular filling
Note 1 to entry: Refer to Figure 3 and Figure 4.
3.20
effective orifice area
EOA
orifice area that has been derived from flow and pressure or velocity data
Note 1 to entry: For in vitro testing, EOA is defined as:
RMS
A =
51,6×
where
A is the effective orifice area (cm );

is the root mean square forward flow (3.54) (ml/s) during the positive differential pressure peri-

RMS
od (3.44);

is the mean pressure difference (measured during the positive differential pressure period)

Δp
(mmHg);
© ISO 2021 – All rights reserved 5
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SIST EN ISO 5840-1:2021
ISO 5840-1:2021(E)
ρ is the density of the test fluid (g/cm ).
3.21
end of diastole

end of forward flow (zero crossing of flow to negative) for mitral and tricuspid positions

Note 1 to entry: ED corresponds to the start of valve closure (SC) for the mitral and tricuspid positions. Refer to

Figure 3 and Figure 4.
3.22
end of positive differential pressure
EPDP

second crossing of aortic and left ventricular pressure waveforms for aortic position; second crossing

of pulmonary and right ventricular pressure waveforms for pulmonary position; second crossing of

atrial and ventricular pressure waveforms for mitral and tricuspid position
Note 1 to entry: Refer to Figure 3 and Figure 4.
3.23
end of systole
end of forward flow (zero crossing
...