ISO 5840-3:2021/Amd 1:2025
(Amendment)Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1
Implants cardiovasculaires — Prothèses valvulaires — Partie 3: Valves cardiaques de substitution implantées par des techniques transcathéter — Amendement 1
General Information
- Status
- Published
- Publication Date
- 03-Mar-2025
- Technical Committee
- ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
- Drafting Committee
- ISO/TC 150/SC 2/WG 1 - Cardiac valves
- Current Stage
- 6060 - International Standard published
- Start Date
- 04-Mar-2025
- Due Date
- 20-May-2025
- Completion Date
- 04-Mar-2025
Relations
- Effective Date
- 25-Nov-2023
Overview
ISO 5840-3:2021/Amd 1:2025 is an important amendment to the ISO 5840-3:2021 international standard, which focuses on cardiovascular implants specifically cardiac valve prostheses delivered by transcatheter techniques. This amendment updates regulatory and technical requirements for heart valve substitutes implanted via minimally invasive transcatheter methods. It addresses performance, safety, and compatibility of these advanced cardiac devices, their delivery systems, accessories, packaging, and labelling.
Developed by ISO Technical Committee ISO/TC 150, Subcommittee SC 2, in cooperation with the European Committee for Standardization (CEN), the document embodies the latest best practices and benchmarks to ensure the quality, reliability, and clinical safety of transcatheter heart valve substitutes.
Key Topics
Scope Expansion: Applies to both newly developed and modified transcatheter heart valve substitutes, delivery systems, accessory devices, packaging, and labelling. This ensures comprehensive coverage of all components involved in the implantation process.
Intended Performance Requirements:
- Safe and accurate loading of valves onto delivery systems.
- Reliable deployment and potential retrieval or repositioning.
- Structural and functional integrity durability throughout the expected device lifetime.
- Anatomical conformity to cardiac structures like coronary ostia, mitral leaflet, conduction system, and interactions with previously implanted devices.
- Efficient forward blood flow with minimal pressure difference.
- Prevention of retrograde flow and paravalvular leakage.
- Resistance to migration, embolization, haemolysis, and thrombus formation.
- Maintenance of biocompatibility and sterility.
- Reproducibility of functionality and shelf life stability.
Testing and Measurement Enhancements:
- Defined accuracy criteria for pressure and flow measurements during hydrodynamic testing to ensure device performance matches clinical conditions.
- Updated testing protocols for pressure cycles, cardiac output, and differential pressure across closed valves, including hypotensive and hypertensive scenarios.
- Clear metrics for regurgitant volume and differential pressure, critical for valve efficacy evaluation.
Safety and Adverse Event Categorization:
- Adverse device effects (ADEs) categorized into serious (SADE) and non-serious types following ISO 14155.
- Classification into anticipated or unanticipated consequences enhances vigilance during clinical use.
Applications
ISO 5840-3:2021/Amd 1:2025 applies broadly to manufacturers, healthcare providers, regulatory bodies, and quality assurance professionals involved in the design, testing, approval, and clinical application of transcatheter heart valve prostheses. Key applications include:
- Device Development: Guiding engineering teams on performance and compatibility requirements for next-generation transcatheter valves and delivery systems.
- Regulatory Compliance: Supporting conformant documentation and testing protocols for market authorization and post-market surveillance.
- Clinical Practice: Assisting cardiovascular surgeons and interventional cardiologists in selecting suitable devices with validated safety and efficiency.
- Quality Control: Enhancing manufacturing and packaging standards to ensure device sterility and longevity.
- Safety Monitoring: Aiding in the reporting and classification of adverse events related to implanted transcatheter valve substitutes.
Related Standards
- ISO 5840 Series: Covers comprehensive standards related to cardiac valve prostheses, including surgical valve substitutes and test methods.
- ISO 14155: Specifies clinical investigation standards for medical devices, particularly regarding adverse event categorization.
- ISO/IEC Directives: Provides guidelines on the development, drafting, and maintenance of ISO standards.
For more details and updated information, stakeholders should consult the official ISO website at www.iso.org and national standards bodies. Implementers are encouraged to verify related patent rights and ensure adherence to the regulatory framework driving transcatheter cardiovascular devices.
Keywords: ISO 5840-3 amendment, transcatheter heart valve prostheses, cardiovascular implants, cardiac valve substitutes, valve delivery systems, implant safety standards, hydrodynamic testing, adverse device effects, valve implantation protocols, biocompatibility standards, heart valve regulations.
ISO 5840-3:2021/Amd 1:2025 - Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques — Amendment 1 Released:4. 03. 2025
ISO 5840-3:2021/Amd 1:2025 - Implants cardiovasculaires — Prothèses valvulaires — Partie 3: Valves cardiaques de substitution implantées par des techniques transcathéter — Amendement 1 Released:4. 03. 2025
Frequently Asked Questions
ISO 5840-3:2021/Amd 1:2025 is a standard published by the International Organization for Standardization (ISO). Its full title is "Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1". This standard covers: Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1
ISO 5840-3:2021/Amd 1:2025 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 5840-3:2021/Amd 1:2025 has the following relationships with other standards: It is inter standard links to ISO 5840-3:2021. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 5840-3:2021/Amd 1:2025 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
International
Standard
ISO 5840-3
Second edition
Cardiovascular implants — Cardiac
2021-01
valve prostheses —
AMENDMENT 1
Part 3:
2025-03
Heart valve substitutes implanted
by transcatheter techniques
AMENDMENT 1
Implants cardiovasculaires — Prothèses valvulaires —
Partie 3: Valves cardiaques de substitution implantées par des
techniques transcathéter
AMENDEMENT 1
Reference number
ISO 5840-3:2021/Amd.1:2025(en) © ISO 2025
ISO 5840-3:2021/Amd.1:2025(en)
© ISO 2025
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 5840-3:2021/Amd.1:2025(en)
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,
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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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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).
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.
iii
ISO 5840-3:2021/Amd.1:2025(en)
Cardiovascular implants — Cardiac valve prostheses —
Part 3:
Heart valve su
...
Norme
internationale
ISO 5840-3
Deuxième édition
Implants cardiovasculaires —
2021-01
Prothèses valvulaires —
AMENDEMENT 1
Partie 3:
2025-03
Valves cardiaques de substitution
implantées par des techniques
transcathéter
AMENDEMENT 1
Cardiovascular implants — Cardiac valve prostheses —
Part 3: Heart valve substitutes implanted by transcatheter
techniques
AMENDMENT 1
Numéro de référence
ISO 5840-3:2021/Amd.1:2025(fr) © ISO 2025
ISO 5840-3:2021/Amd.1:2025(fr)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2025
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii
ISO 5840-3:2021/Amd.1:2025(fr)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes nationaux
de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est en général
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critères d'approbation requis pour les différents types de documents ISO. Le présent document a
été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir
www.iso.org/directives).
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d’un ou de plusieurs brevets. L’ISO ne prend pas position quant à la preuve, à la validité et à l’applicabilité de
tout droit de brevet revendiqué à cet égard. À la date de publication du présent document, l’ISO n'avait pas
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spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion de
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commerce (OTC), voir www.iso.org/avant-propos.
Le présent document a été élaboré par le comité technique ISO/TC 150, Implants chirurgicaux, sous-comité
SC 2, Implants cardiovasculaires et circuits extra-corporels, en collaboration avec le comité technique CEN/
TC 285, Implants chirurgicaux non-actifs, du Comité européen de normalisation (CEN), conformément à
l'Accord de coopération technique entre l'ISO et le CEN (Accord de Vienne).
Une liste de toutes les parties de la série ISO 5840 se trouve sur le site web de l’ISO.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes se
trouve à l’adresse www.iso.org/fr/members.html.
iii
ISO 5840-3:2021/Amd.1:2025(fr)
Implants cardiovasculaires — Prothèses valvulaires —
Partie 3:
Valves cardiaques d
...
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