ISO 5840-2:2021/Amd 1:2025
(Amendment)Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes — Amendment 1
Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes — Amendment 1
Implants cardiovasculaires — Prothèses valvulaires — Partie 2: Prothèses valvulaires implantées chirurgicalement — 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
- 12-Feb-2026
- Effective Date
- 25-Nov-2023
Overview
ISO 5840-2:2021/Amd 1:2025 is an important International Standard amendment that addresses updates to the requirements for cardiovascular implants-specifically, surgically implanted heart valve prostheses. Developed by ISO Technical Committee 150/SC 2 (Cardiovascular implants and extracorporeal systems), this standard amendment ensures that manufacturers, clinicians, and regulators have access to the latest harmonized guidelines and terminology in the rapidly evolving field of cardiac valve substitutes.
With a focus on practical and technical updates, this amendment refines the terminology, normative references, measurement protocols, and labelling requirements for surgically implanted heart valve prostheses. By maintaining alignment with global practices, ISO 5840-2:2021/Amd 1:2025 enhances patient safety, device performance, and market access.
Key Topics
This amendment covers several key updates, including:
- Normative References: Incorporation of ISO/PAS 7020:2023, detailing sizing parameters for surgical valve prostheses and requirements regarding the application of ISO 5840-2.
- Terminology Updates: Revisions such as replacing "supra-annulus" with "supra-annular region" to improve clarity and harmonize anatomical descriptions.
- Measurement Protocols: Updated technical requirements for pressure and flow measurements in valve testing, specifying upper frequency limits and measurement accuracy.
- Table Revisions: Revised parameters for cardiac cycle testing, including beat rates, systolic duration, and conditions (hypotensive, normotensive, severe hypertensive).
- Reporting Requirements: Refined expectations for reporting regurgitant volume, differentiating between closing volume, leakage volume, and associated differential pressure.
- Labelling and Documentation: Alignment of labelling requirements with ISO 5840-1:2021 and ISO/PAS 7020:2023, ensuring consistency in device identification and model description.
Applications
Implementing ISO 5840-2:2021/Amd 1:2025 provides practical benefits across the global medical device industry:
- Medical Device Manufacturers: Ensures cardiac valve prostheses meet the latest safety, performance, and labelling requirements, streamlining regulatory approval and market access globally.
- Regulatory Authorities: Offers a harmonized foundation for reviewing and approving surgically implanted heart valve substitutes, ensuring patient safety through adherence to internationally recognized standards.
- Clinical Laboratories and Test Facilities: Supports accurate and repeatable measurement procedures for device testing, facilitating compliance with updated validation criteria.
- Clinicians and Healthcare Providers: Provides clear device labelling and terminology, improving communication, device selection, and patient care management.
By adhering to ISO 5840-2:2021/Amd 1:2025, organizations can support product quality, reduce compliance risks, and foster trust with stakeholders.
Related Standards
Professionals working with surgically implanted heart valve substitutes should also be aware of related standards that form the foundation of best practices in cardiovascular implants:
- ISO 5840 Series: Comprehensive family of standards covering all aspects of cardiac valve prostheses.
- ISO 5840-1:2021: Heart valve substitutes implanted by any technique-General requirements.
- ISO 5840-2:2021: Surgically implanted heart valve substitutes-Main standard framework.
- ISO/PAS 7020:2023: Details on sizing parameters and application requirements for surgical valve prostheses.
- Other Related ISO Standards: Various standards addressing design, performance, testing, and labelling for implants for surgery.
Staying updated with these standards is essential for regulatory compliance, innovation, and optimal patient outcomes in cardiovascular device development and implantation.
Buy Documents
ISO 5840-2:2021/Amd 1:2025 - Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes — Amendment 1 Released:3/4/2025
ISO 5840-2:2021/Amd 1:2025 - Implants cardiovasculaires — Protheses valvulaires — Partie 2: Protheses valvulaires implantées chirurgicalement — Amendement 1 Released:3/4/2025
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Frequently Asked Questions
ISO 5840-2:2021/Amd 1:2025 is a standard published by the International Organization for Standardization (ISO). Its full title is "Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes — Amendment 1". This standard covers: Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes — Amendment 1
Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes — Amendment 1
ISO 5840-2:2021/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 5840-2:2021/Amd 1:2025 has the following relationships with other standards: It is inter standard links to EN ISO 5840-2:2021/A1:2025, ISO 5840-2:2021. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 5840-2:2021/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 5840-2
Second edition
Cardiovascular implants — Cardiac
2021-01
valve prostheses —
AMENDMENT 1
Part 2:
2025-03
Surgically implanted heart valve
substitutes
AMENDMENT 1
Implants cardiovasculaires — Prothèses valvulaires —
Partie 2: Prothèses valvulaires implantées chirurgicalement
AMENDEMENT 1
Reference number
ISO 5840-2:2021/Amd.1:2025(en) © ISO 2025
ISO 5840-2:2021/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 5840-2:2021/Amd.1:2025(en)
Foreword
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Norme
internationale
ISO 5840-2
Deuxième édition
Implants cardiovasculaires —
2021-01
Prothèses valvulaires —
AMENDEMENT 1
Partie 2:
2025-03
Prothèses valvulaires implantées
chirurgicalement
AMENDEMENT 1
Cardiovascular implants — Cardiac valve prostheses —
Part 2: Surgically implanted heart valve substitutes
AMENDMENT 1
Numéro de référence
ISO 5840-2:2021/Amd.1:2025(fr) © ISO 2025
ISO 5840-2:2021/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 5840-2:2021/Amd.1:2025(fr)
Avant-propos
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