Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)

This document is applicable to heart valve substitutes intended for implantation in human hearts,
generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for
examples of surgical heart valve substitutes and their components.
This document is applicable to both newly developed and modified surgical heart valve substitutes and
to the accessory devices, packaging, and labelling required for their implantation and for determining
the appropriate size of the surgical heart valve substitute to be implanted.
This document establishes an approach for verifying/validating 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 can include those to assess the
physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of
their materials and components. The tests can also include those for pre-clinical in vivo evaluation and
clinical evaluation of the finished surgical heart valve substitute.
This document defines operational conditions and performance requirements for surgical heart valve
substitutes where adequate scientific and/or clinical evidence exists for their justification.
For some heart valve substitutes (e.g. sutureless), the requirements of both this document and
ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are
based on the results of the risk analysis.

Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter Herzklappenersatz (ISO 5840-2:2021)

Das Dokument ist auf Herzklappenersatz anwendbar, der für die Implantation im menschlichen Herzen vorgesehen ist, für die in der Regel ein kardiopulmonaler Bypass und direkte Sichtbarkeit erforderlich sind. Bezüglich Beispielen für chirurgisch implantierten Herzklappenersatz und dessen Bestandteilen siehe Anhang E.
Das Dokument ist sowohl auf neu entwickelten als auch auf veränderten chirurgisch implantierten Herzklappenersatz und seine Zubehörteile anwendbar und gilt für die Verpackung und die für die Implantation und die Ermittlung der geeigneten Größe des chirurgisch zu implantierenden Herzklappen¬ersatzes erforderliche Kennzeichnung.
Dieses Dokument legt eine Herangehensweise zur Verifizierung/Validierung des Designs und der Herstellung eines chirurgisch zu implantierenden Herzklappenersatzes auf der Grundlage des Risiko-managements fest. Die Auswahl der geeigneten Qualifikationsprüfungen und  verfahren leitet sich aus der Risikobeurteilung ab. Zu diesen Prüfungen können solche zur Beurteilung der physikalischen, chemischen, biologischen und mechanischen Eigenschaften eines chirurgisch zu implantierenden Herzklappenersatzes und von dessen Werkstoffen und Bauteilen gehören. Diese Prüfungen können auch die vorklinische In vivo-Bewertung und die klinische Bewertung des fertigen chirurgisch implantierten Herzklappenersatzes einschließen.
Dieses Dokument legt Betriebsbedingungen für und Leistungsanforderungen an chirurgisch implantierten Herzklappenersatz fest, sofern angemessene wissenschaftliche und/oder klinische Nachweise für deren Begründung vorliegen.
Für einige Herzklappenprothesen (z. B. nahtlos) können die Anforderungen sowohl dieses Dokuments als auch von ISO 5840 3:2021 von Bedeutung sein und werden als für das spezifische Implantatdesign anwendbar angesehen und basieren auf den Ergebnissen der Risiko¬analyse.

Implants cardiovasculaires - Prothèses valvulaires - Partie 2: Prothèse valvulaires implantées chirurgicalement (ISO 5840-2:2021)

Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 2. del: Kirurško vsajeni (implantirani) nadomestki srčne zaklopke (ISO 5840-2:2021)

General Information

Status
Published
Public Enquiry End Date
19-Mar-2019
Publication Date
21-Feb-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Feb-2021
Due Date
18-Apr-2021
Completion Date
22-Feb-2021

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SLOVENSKI STANDARD
SIST EN ISO 5840-2:2021
01-marec-2021
Nadomešča:
SIST EN ISO 5840-2:2015

Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 2. del: Kirurško

vsajeni (implantirani) nadomestki srčne zaklopke (ISO 5840-2:2021)

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart

valve substitutes (ISO 5840-2:2021)

Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter

Herzklappenersatz (ISO 5840-2:2021)

Implants cardiovasculaires - Prothèses valvulaires - Partie 2: Prothèse valvulaires

implantées chirurgicalement (ISO 5840-2:2021)
Ta slovenski standard je istoveten z: EN ISO 5840-2:2021
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 5840-2:2021 en

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

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SIST EN ISO 5840-2:2021
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SIST EN ISO 5840-2:2021
EN ISO 5840-2
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2021
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 5840-2:2015
English Version
Cardiovascular implants - Cardiac valve prostheses - Part
2: Surgically implanted heart valve substitutes (ISO 5840-
2:2021)

Implants cardiovasculaires - Prothèses valvulaires - Herz- und Gefäßimplantate - Herzklappenprothesen -

Partie 2: Prothèse valvulaires implantées Teil 2: Chirurgisch implantierter Herzklappenersatz

chirurgicalement (ISO 5840-2:2021) (ISO 5840-2:2021)
This European Standard was approved by CEN on 21 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 5840-2:2021 E

worldwide for CEN national Members.
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SIST EN ISO 5840-2:2021
EN ISO 5840-2:2021 (E)
Contents Page

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

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SIST EN ISO 5840-2:2021
EN ISO 5840-2:2021 (E)
European foreword

This document (EN ISO 5840-2:2021) 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 5840-2:2015.

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 5840-2:2021 has been approved by CEN as EN ISO 5840-2:2021 without any

modification.
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SIST EN ISO 5840-2:2021
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SIST EN ISO 5840-2:2021
INTERNATIONAL ISO
STANDARD 5840-2
Second edition
2021-01
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 5840-2:2021(E)
ISO 2021
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SIST EN ISO 5840-2:2021
ISO 5840-2:2021(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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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SIST EN ISO 5840-2:2021
ISO 5840-2:2021(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Abbreviations........................................................................................................................................................................................................... 3

5 Fundamental requirements ...................................................................................................................................................................... 4

6 Device description .............................................................................................................................................................................................. 4

6.1 General ........................................................................................................................................................................................................... 4

6.2 Intended use .............................................................................................................................................................................................. 4

6.3 Design inputs ............................................................................................................................................................................................ 4

6.3.1 Operational specifications ....................................................................................................................................... 4

6.3.2 Performance specifications .................................................................................................................................... 4

6.3.3 Packaging, labelling, and sterilization ........................................................................................................... 5

6.4 Design outputs ........................................................................................................................................................................................ 5

6.5 Design transfer (manufacturing verification/validation) .................................................................................. 5

6.6 Risk management ................................................................................................................................................................................. 6

7 Design verification and validation ..................................................................................................................................................... 6

7.1 General requirements ....................................................................................................................................................................... 6

7.2 In vitro assessment ............................................................................................................................................................................ 6

7.2.1 General...................................................................................................................................................................................... 6

7.2.2 Test conditions, sample selection, and reporting requirements ............................................ 6

7.2.3 Material property assessment ............................................................................................................................. 6

7.2.4 Hydrodynamic performance assessment ................................................................................................... 6

7.2.5 Structural performance assessment ............................................................................................................... 7

7.2.6 Design- or procedure-specific testing............................................................................................................ 8

7.2.7 Device MRI compatibility ......................................................................................................................................... 8

7.2.8 Simulated use...................................................................................................................................................................... 8

7.2.9 Human factors/usability assessment ............................................................................................................ 8

7.2.10 Implant thrombogenic and haemolytic potential assessment ................................................. 8

7.3 Preclinical in vivo evaluation ..................................................................................................................................................... 8

7.3.1 General...................................................................................................................................................................................... 8

7.3.2 Overall requirements ................................................................................................................................................... 8

7.3.3 Methods ................................................................................................................................................................................... 9

7.3.4 Test report ..........................................................................................................................................................................10

7.4 Clinical investigations ....................................................................................................................................................................11

7.4.1 General...................................................................................................................................................................................11

7.4.2 Study considerations .................................................................................................................................................12

7.4.3 Study endpoints .............................................................................................................................................................13

7.4.4 Ethical considerations ..............................................................................................................................................14

7.4.5 Pivotal studies: Distribution of subjects and investigators ......................................................14

7.4.6 Statistical considerations including sample size and duration ............................................15

7.4.7 Patient selection criteria ........................................................................................................................................16

7.4.8 Valve thrombosis prevention .............................................................................................................................17

7.4.9 Clinical data requirements ...................................................................................................................................17

Annex A (informative) Surgical heart valve substitute hazard analysis example ...............................................22

Annex B (informative) In vitro procedures for testing unstented or similar valves in

compliant chambers ......................................................................................................................................................................................24

Annex C (informative) Preclinical in vivo evaluation .......................................................................................................................26

Annex D (informative) Description of the surgical heart valve substitute and system.................................29

© ISO 2021 – All rights reserved iii
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SIST EN ISO 5840-2:2021
ISO 5840-2:2021(E)

Annex E (informative) Examples of components of some surgical heart valve substitutes

and systems .............................................................................................................................................................................................................31

Annex F (informative) Guidelines for verification of hydrodynamic performance —

Pulsatile flow testing .....................................................................................................................................................................................37

Annex G (informative) Examples of design specific testing .......................................................................................................41

Annex H (informative) Fatigue assessment ................................................................................................................................................43

Annex I (normative) Methods of evaluating clinical data against objective performance criteria ..45

Annex J (normative) Adverse event classification during clinical investigation .................................................46

Bibliography .............................................................................................................................................................................................................................51

iv © ISO 2021 – All rights reserved
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SIST EN ISO 5840-2:2021
ISO 5840-2:2021(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 5840-2:2015), 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 of its 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 5840-2:2021
ISO 5840-2:2021(E)
Introduction

This document has been prepared for surgical heart valve substitutes with emphasis on providing

guidance for 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 document is used in conjunction with ISO 5840-1 and ISO 5840-3.
vi © ISO 2021 – All rights reserved
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SIST EN ISO 5840-2:2021
INTERNATIONAL STANDARD ISO 5840-2:2021(E)
Cardiovascular implants — Cardiac valve prostheses —
Part 2:
Surgically implanted heart valve substitutes
1 Scope

This document is applicable to heart valve substitutes intended for implantation in human hearts,

generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for

examples of surgical heart valve substitutes and their components.

This document is applicable to both newly developed and modified surgical heart valve substitutes and

to the accessory devices, packaging, and labelling required for their implantation and for determining

the appropriate size of the surgical heart valve substitute to be implanted.

This document establishes an approach for verifying/validating 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 can include those to assess the

physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of

their materials and components. The tests can also include those for pre-clinical in vivo evaluation and

clinical evaluation of the finished surgical heart valve substitute.

This document defines operational conditions and performance requirements for surgical heart valve

substitutes where adequate scientific and/or clinical evidence exists for their justification.

For some heart valve substitutes (e.g. sutureless), the requirements of both this document and

ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are

based on the results of the risk analysis.
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 5840-1:2021, Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements

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

implanted by transcatheter techniques

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 16061, Instrumentation for use in association with non-active surgical implants — General requirements

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 5840-1:2021 and the

following apply.
© ISO 2021 – All rights reserved 1
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SIST EN ISO 5840-2:2021
ISO 5840-2:2021(E)

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
acute assessment

intra-procedural and immediate post-procedural results used to assess in vivo safety and performance

Note 1 to entry: All animals entered into acute short-term assessment shall remain under general anaesthesia for

the duration of the study.
3.2
chronic assessment

long-term results following the procedure used to assess chronic in vivo safety and performance after

the animal has recovered from anaesthesia

Note 1 to entry: The endpoints and durations of these studies should be determined by risk analysis.

3.3
component-joining material

material such as a suture, adhesive, or welding compound used to assemble the components of a heart

valve system
[SOURCE: ISO 5840-1:2021, 3.31]
3.4
external sewing ring diameter
ESRD
outside diameter in millimetres of the sewing ring at the largest point
Note 1 to entry: See Figure 1.
Note 2 to entry: See also 3.5, 3.7 and 3.8.
3.5
prosthesis minimum internal diameter

numerical indication of the minimum diameter within a fully assembled

flexible surgical heart valve substitute and which is measured with a standard validated procedure,

taking the entire flow channel into consideration
Note 1 to entry: See Figure 1.
Note 2 to entry: See also 3.2 and 3.4.
3.6
prosthesis minimum internal diameter

measurement of the prosthesis minimum internal housing diameter

Note 1 to entry: See Figure 1.
Note 2 to entry: See also 3.2 and 3.4.
3.7
intra-annular
wholly or partially within the patient’s annulus
Note 1 to entry: See Figure 1.
Note 2 to entry: See also 3.4, 3.5 and 3.8.
2 © ISO 2021 – All rights reserved
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SIST EN ISO 5840-2:2021
ISO 5840-2:2021(E)
a) Aortic/pulmonic b) Aortic/pulmonic c) Mitral/tricuspid
intra-annular supra-annular intra-annular
Key
1 prosthesis minimum internal diameter
2 patient annulus diameter
3 external sewing ring diameter

Figure 1 — Designation of dimensions of surgical heart valve substitute sewing ring

configurations
3.8
supra-annulus
region wholly above the patient’s annulus
Note 1 to entry: See Figure 1.
Note 2 to entry: See also 3.4, 3.5, and 3.7.
3.9
patient annulus diameter
PAD

diameter in millimetres of the smallest flow area within the patient’s valve annulus

Note 1 to entry: See Figure 1.
3.10
valve size
designated valve size

manufacturer's designation of a surgical heart valve substitute which indicates the intended patient

annulus diameter
Note 1 to entry: The valve size is equivalent to the PAD (3.9).

Note 2 to entry: This takes into consideration the manufacturer's recommended implant position relative to the

annulus and the suture technique.
4 Abbreviations
For the purposes of this document, the following abbreviations apply.
AE adverse event
CIP clinical investigation plan
CRF case report form
© ISO 2021 – All rights reserved 3
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SIST EN ISO 5840-2:2021
ISO 5840-2:2021(E)
CT computed tomography
EOA effective orifice area
FEA finite element analysis
IFU instructions for use
LVOT left ventricular outflow tract
MRI magnetic resonance imaging
OPC objective performance criteria
PMCF post-market clinical follow-up
PVL paravalvular leak
RMS root mean square
SAE serious adverse event
TEE transoesophageal echo
TTE transthoracic echo
5 Fundamental requirements
Refer to ISO 5840-1:2021, Clause 5.
6 Device description
6.1 General
Refer to ISO 5840-1:2021, 6.1.
6.2 Intended use
Refer to ISO 5840-1:2021, 6.2.
6.3 Design inputs
6.3.1 Operational specifications
Refer to ISO 5840-1:2021, 6.3.1.
6.3.2 Performance specifications
6.3.2.1 General
Refer to ISO 5840-1:2021, 6.1 for general requirements.
6.3.2.2 Surgical heart valve substitute minimum performance requirements

Surgical heart valves shall meet the following minimum performance specifications:

— allow forward flow with acceptably small mean pressure difference;
4 © ISO 2021 – All rights reserved
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SIST EN ISO 5840-2:2021
ISO 5840-2:2021(E)
— prevent retrograde flow with acceptably small regurgitation;
— resist embolization;
— avoid haemolysis;
— resist thrombus formation;
— be biocompatible;
— be compatible with in vivo diagnostic techniques;
— be deliverable and implantable in the target population;
— be able to ensure effective fixation within the target implant site;
— have an acceptable noise level;
— have reproducible function;

— maintain structural and functional integrity during the expected lifetime of the device;

— maintain its functionality and sterility for a reasonable shelf life prior to implantation.

6.3.2.3 Accessories

The requirements of ISO 16061 for instruments used with surgical implants shall apply. Surgical heart

valve accessories shall mitigate the risk of the valve being inadvertently implanted upside down.

Examples of surgical valve accessories, including sizing tools and valve handles, are shown in Annex E.

6.3.2.4 Implant procedure
Refer to ISO 5840-1:2021, 6.3.3.
6.3.3 Packaging, labelling, and sterilization
Refer to ISO 5840-1:2021, 6.3.4.

In addition to the items specified in ISO 5840-1:2021, C.1.3, outer container labelling for the valve

implant shall include in diagrammatic and/or tabular form the following items:
— intended valve to be replaced;
— intended position in relation to the annulus;
— inflow internal orifice diameter;
— prosthesis minimum internal diameter;
— external sewing ring diameter (ESRD).

Annex D contains a list of terms that may be used in describing various valve models.

6.4 Design outputs
Refer to ISO 5840-1:2021, 6.4.
6.5 Design transfer (manufacturing verification/validation)
Refer to ISO 5840-1:2021, 6.5.
© ISO 2021 – All rights reserved 5
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SIST EN ISO 5840-2:2021
ISO 5840-2:2021(E)
6.6 Risk management
Refer to ISO 5840-1:2021, 6.6.

Annex A contains a list of potential hazards specific to surgical heart valve substitutes that can serve as

the basis for a risk analysis.
7 Design verification and validation
7.1 General requirements

In vitro assessment shall be used to mitigate the risks identified in the risk analysis. General

requirem
...

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