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SIST

SIST 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: Prothèse 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

Status
Published
Public Enquiry End Date
29-Apr-2024
Publication Date
02-Apr-2025
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
VAZ - Healthcare
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
27-Mar-2025
Due Date
01-Jun-2025
Completion Date
03-Apr-2025
Ref Project
EN ISO 5840-2:2021/A1:2025 - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/Amd 1:2025)

Relations

Amends
SIST EN ISO 5840-2:2021 - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)
Effective Date
01-May-2025

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EN ISO 5840-2:2021/A1:2025
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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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