EN ISO 5840-2:2021/A1:2025
(Amendment)Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/Amd 1:2025)
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/Amd 1:2025)
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter Herzklappenersatz - Änderung 1 (ISO 5840-2:2021/Amd 1:2025)
Implants cardiovasculaires - Prothèses valvulaires - Partie 2: Prothèses valvulaires implantées chirurgicalement - Amendement 1 (ISO 5840-2:2021/Amd 1:2025)
Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 2. del: Kirurško vsajeni (implantirani) nadomestki srčne zaklopke - Dopolnilo A1 (ISO 5840-2:2021/Amd 1:2025)
General Information
Relations
Overview
EN ISO 5840-2:2021/A1:2025 is a key European amendment to the international standard ISO 5840-2:2021, developed under the collaboration of ISO Technical Committee ISO/TC 150 and CEN Technical Committee CEN/TC 285. This amendment, approved in March 2025, focuses on cardiovascular implants specifically related to surgically implanted cardiac valve prostheses. It provides essential updates for the design, testing, and labeling requirements crucial for ensuring the safety, performance, and reliability of heart valve substitutes used in surgical implantation.
This standard is intended for manufacturers, regulators, and healthcare professionals involved in the development, approval, and clinical use of surgical heart valve prostheses. The amendment brings clarity on terminology, technical specifications, and measurement criteria to align with the latest technological advancements and clinical needs, supporting improved patient outcomes in cardiovascular treatments.
Key Topics
Terminology Updates
The amendment revises and clarifies terms such as replacing "supra-annulus" with "supra-annular region," providing precise anatomical definitions to ensure consistent communication in valve design and testing.Normative References and Labeling
New references include ISO/PAS 7020:2023 relating to sizing parameters of surgical valve prostheses, emphasizing requirements for valve labeling that align with patient safety and regulatory compliance.Measurement and Testing Specifications
Enhanced accuracy and frequency limits for pressure and flow measurements are specified:- Pressure measurements (ventricular, aortic) must meet a minimum accuracy of ±0.26 kPa (±2 mmHg) and an upper frequency limit of at least 30 Hz.
- Flow meters should have an equivalent upper frequency response.
These criteria ensure reliable performance testing under physiologically relevant conditions.
Hemodynamic Performance Assessment
The amendment updates testing protocols including beat rates, systolic durations, cardiac outputs, and differential pressures across the closed valve, reflecting hypotensive to severe hypertensive states to simulate diverse clinical scenarios.Regurgitant Volume Measurement
Specifies requirements for quantifying regurgitant volume, including closing and leakage volumes, expressed both in milliliters and as a percentage of forward flow. This provides precise metrics to assess valve competence.
Applications
Medical Device Manufacturing
Manufacturers of cardiac valve prostheses utilize this amendment to refine design controls, validate valve performance, and develop compliant labeling practices, essential for regulatory approvals and market access in Europe and beyond.Regulatory Compliance
National standards bodies in CEN member countries are mandated to adopt this amendment, ensuring harmonized regulatory requirements for surgical heart valve implants across Europe, supporting patient safety and facilitating international trade.Clinical Engineering and Research
Provides a standardized framework for clinical engineers, researchers, and healthcare providers to evaluate valve substitutes' mechanical and hemodynamic properties under clinically relevant conditions, aiding in device selection and patient-specific treatment planning.Quality Assurance and Testing Laboratories
Testing laboratories apply the detailed measurement accuracy, frequency response, and performance protocols to ensure heart valve devices meet stringent quality and safety benchmarks before clinical use.
Related Standards
EN ISO 5840-1:2021 – Covers general requirements and test methods for cardiac valve prostheses, serving as a complementary reference for surgical valve standards.
ISO/PAS 7020:2023 – Establishes sizing parameters and labeling requirements related to surgical valve prostheses, referenced in this amendment for detailed guidance.
ISO/IEC Directives Part 1 & 2 – Provides editorial and approval procedures supporting the development and maintenance of ISO standards, applicable to this amendment.
Other parts of ISO 5840 series – Address different types of cardiac valve prostheses such as transcatheter heart valves, essential for comprehensive standards coverage in cardiovascular implants.
Keywords: EN ISO 5840-2 amendment 2025, cardiac valve prostheses standard, surgical heart valve substitutes, cardiovascular implants, valve prosthesis testing, heart valve labeling, hemodynamic performance testing, valve regurgitation metrics, CEN standards compliance.
Frequently Asked Questions
EN ISO 5840-2:2021/A1:2025 is a amendment published by the European Committee for Standardization (CEN). Its full title is "Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/Amd 1:2025)". This standard covers: Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/Amd 1:2025)
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/Amd 1:2025)
EN ISO 5840-2:2021/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 5840-2:2021/A1:2025 has the following relationships with other standards: It is inter standard links to EN ISO 5840-2:2021. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN ISO 5840-2:2021/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 - 2. del: Kirurško
vsajeni (implantirani) nadomestki srčne zaklopke - Dopolnilo A1 (ISO 5840-
2:2021/Amd 1:2025)
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart
valve substitutes - Amendment 1 (ISO 5840-2:2021/Amd 1:2025)
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter
Herzklappenersatz - Änderung 1 (ISO 5840-2:2021/Amd 1:2025)
Implants cardiovasculaires - Prothèses valvulaires - Partie 2: Prothèse valvulaires
implantées chirurgicalement - Amendement 1 (ISO 5840-2:2021/Amd 1:2025)
Ta slovenski standard je istoveten z: EN ISO 5840-2:2021/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 5840-2:2021/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2025
EUROPÄISCHE NORM
ICS 11.040.40
English Version
Cardiovascular implants - Cardiac valve prostheses - Part
2: Surgically implanted heart valve substitutes -
Amendment 1 (ISO 5840-2:2021/Amd 1:2025)
Implants cardiovasculaires - Prothèses valvulaires - Herz- und Gefäßimplantate - Herzklappenprothesen -
Partie 2: Prothèses valvulaires implantées Teil 2: Chirurgisch implantierter Herzklappenersatz -
chirurgicalement - Amendement 1 (ISO 5840- Änderung 1 (ISO 5840-2:2021/Amd 1:2025)
2:2021/Amd 1:2025)
This amendment A1 modifies the European Standard EN ISO 5840-2:2021; 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 5840-2:2021/A1:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 5840-2:2021/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 5840-2:2021 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 5840-2:2021/Amd 1:2025 has been approved by CEN as EN ISO 5840-2:2021/A1:2025
without any modification.
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:
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