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
Relations
Overview
EN ISO 5840-3:2021/A1:2025 is an important amendment to the international standard governing cardiovascular implants, specifically focusing on cardiac valve prostheses implanted by transcatheter techniques. Published by the European Committee for Standardization (CEN) in March 2025, this amendment updates and clarifies requirements for heart valve substitutes delivered via minimally invasive, catheter-based procedures. It sets essential guidelines to ensure safety, performance, and reliability of transcatheter heart valves, associated delivery systems, and accessories. This standard supports medical device manufacturers, healthcare professionals, and regulatory bodies by harmonizing technical expectations for new and modified heart valve implants implanted through transcatheter methods.
Key Topics
- Scope Expansion: Includes newly developed and modified transcatheter heart valve substitutes, delivery systems, accessory devices, packaging, labeling, and sizing guidance.
- Intended Performance Criteria: Defines critical functional attributes such as:
- Accurate loading and safe deployment on delivery systems
- Safe retrieval and repositioning capabilities
- Structural integrity and durability over device lifetime
- Anatomical conformity and interaction within implant sites (aortic, mitral positions, etc.)
- Compatibility with previously implanted devices
- Efficient forward blood flow with low pressure gradient
- Prevention of retrograde flow and paravalvular leakage
- Resistance to migration, embolization, hemolysis, and thrombus formation
- Biocompatibility and stable shelf life prior to implantation
- Reproducibility of device function
- Testing and Measurement Updates: Specifications for pressure and flow measurement accuracy and frequency response to ensure reliable hydrodynamic performance testing.
- Adverse Device Effects Management: Categorization of adverse effects into serious and non-serious, aligned with ISO 14155 clinical investigation standards, emphasizing patient safety and risk management.
- Hydrodynamic Performance Testing: Updated conditions for evaluating valve performance across heart rates and blood pressure scenarios, including hypotensive to severe hypertensive conditions.
Applications
- Medical Device Manufacturing: Supports design and development of transcatheter heart valve prostheses ensuring compliance with harmonized safety and performance standards.
- Quality Assurance and Regulatory Compliance: Provides benchmark criteria for regulatory approvals, clinical evaluation, and post-market surveillance of cardiovascular implants.
- Clinical Practice: Enables cardiologists and cardiac surgeons to select validated transcatheter heart valves with predictable functional outcomes and minimized complications.
- Product Labeling and Packaging: Standardizes information for implant sizing, handling, and implantation procedures to optimize patient outcomes and procedural safety.
- Research and Innovation: Serves as a foundation for developing novel transcatheter valve technologies and accessories with validated performance characteristics.
Related Standards
- ISO 5840 Series: EN ISO 5840-3:2021/A1:2025 is part 3 of this series, which covers cardiac valve prostheses, including surgical and transcatheter implanted heart valves.
- ISO 14155: Clinical investigation of medical devices for human subjects, referenced for adverse device effect reporting and safety monitoring.
- EN ISO 5840-1: General requirements for cardiac valve prostheses, including terminology, functionality, and test methods that complement part 3 specifications.
- CEN/TC 285 Standards: Related non-active surgical implant standards developed in collaboration with ISO technical committees.
This amendment enhances the harmonization and clarity of requirements for transcatheter cardiac valve implants, facilitating innovation, ensuring patient safety, and promoting consistent performance across European and international markets. Manufacturers and healthcare providers are encouraged to align their products and practices with the updated EN ISO 5840-3:2021/A1:2025 to meet evolving clinical and regulatory expectations.
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 EN ISO 5840-3:2021. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN ISO 5840-3:2021/A1:2025 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
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
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...