EN ISO 5840-3:2021/A1:2025
(Amendment)Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840-3:2021/Amd 1:2025)
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840-3:2021/Amd 1:2025)
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 3: Durch minimal-invasive Methoden implantierter Herzklappenersatz - Änderung 1 (ISO 5840 3:2021/Amd 1:2025)
Implants cardiovasculaires - Prothèses valvulaires - Partie 3: Valves cardiaques de substitution implantées par des techniques transcathéter - Amendement 1 (ISO 5840-3:2021/Amd 1:2025)
Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 3. del: Nadomestki srčne zaklopke, vsajeni (implantirani) s transkatetrsko metodo - Dopolnilo A1 (ISO 5840-3:2021/Amd 1:2025)
General Information
- Status
- Published
- Publication Date
- 18-Mar-2025
- Technical Committee
- CEN/TC 285 - Non-active surgical implants
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 19-Mar-2025
- Completion Date
- 19-Mar-2025
Relations
- Effective Date
- 12-Feb-2026
- Effective Date
- 22-Nov-2023
Overview
EN ISO 5840-3:2021/A1:2025 is an important European and international standard that specifies requirements for cardiovascular implants, particularly cardiac valve prostheses designed for implantation using transcatheter techniques. This Amendment 1 updates the original EN ISO 5840-3:2021 and reflects the latest consensus and technical advancements related to heart valve substitutes, covering newly developed and modified products, their delivery systems, packaging, labelling, and performance evaluation.
Developed collaboratively by CEN (European Committee for Standardization) and ISO, this standard provides harmonized guidelines essential for medical device manufacturers, healthcare professionals, and regulatory authorities involved with transcatheter heart valve implants. It ensures the safety, quality, and performance of products in this rapidly evolving sector.
Key Topics
The standard amendment addresses several critical areas related to transcatheter heart valve substitutes:
- Applicability: Covers both new and modified transcatheter heart valve devices, including their delivery systems and accessory components.
- Performance Criteria: Establishes key performance requirements, such as:
- Safe, accurate loading and deployment of the valve on the delivery system
- Retrieval and repositioning capabilities (if applicable)
- Long-term structural and functional integrity of the device
- Compatibility and interaction with cardiac anatomical structures and other implants
- Maintenance of forward blood flow with minimal pressure difference
- Effective prevention of backward flow and minimization of leakage
- Resistance to device migration, embolization, hemolysis, and thrombus formation
- Device biocompatibility and sterility
- Reproducibility of functional results
- Testing Methods: Provides clear measurement requirements for pressure and flow, ensuring the precision and reliability of in vitro testing.
- Adverse Events Reporting: Aligns reporting of adverse device effects (ADE) with ISO 14155, distinguishing between serious and non-serious events for clinical risk management.
Applications
The scope of EN ISO 5840-3:2021/A1:2025 covers practical, clinical, and regulatory applications, including:
- Manufacturing & Design: Assists manufacturers in developing and validating transcatheter heart valve prostheses and associated delivery devices to meet recognized international benchmarks.
- Quality Assurance: Facilitates robust quality control, packaging, and labelling processes to ensure product safety and traceability.
- Clinical Evaluation: Supports clinicians and regulatory authorities in assessing device safety, functionality, and performance during pre-clinical and clinical stages.
- Compliance & Approval: Provides a foundation for regulatory submissions, conformity assessment, and CE marking processes in the European and global medical device markets.
Related Standards
For a comprehensive approach to cardiac valve prostheses and cardiovascular implants, consider these related standards:
- EN ISO 5840-1: General requirements for heart valve substitutes
- EN ISO 5840-2: Requirements for surgically implanted heart valve substitutes
- ISO 14155: Clinical investigation of medical devices for human subjects - Good clinical practice
These standards, together with EN ISO 5840-3:2021/A1:2025, help establish a rigorous framework for the design, testing, and clinical use of heart valve substitutes, supporting patient safety and fostering innovation in cardiac care.
Ensure that all device development and evaluation processes are aligned with the latest amendments and harmonized standards to meet global best practices and regulatory requirements in the cardiovascular medical device industry.
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Frequently Asked Questions
EN ISO 5840-3:2021/A1:2025 is a amendment published by the European Committee for Standardization (CEN). Its full title is "Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840-3:2021/Amd 1:2025)". This standard covers: Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840-3:2021/Amd 1:2025)
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840-3:2021/Amd 1:2025)
EN ISO 5840-3:2021/A1:2025 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.
EN ISO 5840-3:2021/A1:2025 has the following relationships with other standards: It is inter standard links to ISO 5840-3:2021/Amd 1:2025, EN ISO 5840-3:2021. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 5840-3:2021/A1:2025 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)
SLOVENSKI STANDARD
01-maj-2025
Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 3. del:
Nadomestki srčne zaklopke, vsajeni (implantirani) s transkatetrsko metodo -
Dopolnilo A1 (ISO 5840-3:2021/Amd 1:2025)
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes
implanted by transcatheter techniques - Amendment 1 (ISO 5840-3:2021/Amd 1:2025)
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 3: Durch Minimal-Invasive
Methoden Implantierter Herzklappenersatz - Änderung 1 (ISO 5840-3:2021/Amd 1:2025)
Implants cardiovasculaires - Prothèses valvulaires - Partie 3: Valves cardiaques de
substitution implantées par des techniques transcathéter - Amendement 1 (ISO 5840-
3:2021/Amd 1:2025)
Ta slovenski standard je istoveten z: EN ISO 5840-3:2021/A1:2025
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 5840-3:2021/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2025
EUROPÄISCHE NORM
ICS 11.040.40
English Version
Cardiovascular implants - Cardiac valve prostheses - Part
3: Heart valve substitutes implanted by transcatheter
techniques - Amendment 1 (ISO 5840-3:2021/Amd
1:2025)
Implants cardiovasculaires - Prothèses valvulaires - Herz- und Gefäßimplantate - Herzklappenprothesen -
Partie 3: Valves cardiaques de substitution implantées Teil 3: Durch Minimal-Invasive Methoden
par des techniques transcathéter - Amendement 1 (ISO Implantierter Herzklappenersatz - Änderung 1 (ISO
5840-3:2021/Amd 1:2025) 5840-3:2021/Amd 1:2025)
This amendment A1 modifies the European Standard EN ISO 5840-3:2021; it was approved by CEN on 12 March 2025.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, Türkiye 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5840-3:2021/A1:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 5840-3:2021/A1:2025) 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 Amendment to the European Standard EN ISO 5840-3:2021 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by September 2025,
and conflicting national standards shall be withdrawn at the latest by September 2025.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 5840-3:2021/Amd 1:2025 has been approved by CEN as EN ISO 5840-3:2021/A1:2025
without any modification.
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
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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
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