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CEN

EN ISO 5840-3:2021/FprA1:2024

(Amendment)

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840-3:2021/FDAmd1:2024)

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840-3:2021/FDAmd1:2024)

Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 3: Durch Minimal-Invasive Methoden Implantierter Herzklappenersatz - Änderung 1 (ISO 5840 3:2021/FDAmd 1:2024)

Implants cardiovasculaires - Prothèses valvulaires - Partie 3: Valves cardiaques de substitution implantées par des techniques transcathéter - Amendement 1 (ISO 5840-3:2021/FDAmd1:2024)

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/DAM 1:2024)

General Information

Status
Not Published
Publication Date
11-May-2025
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/TC 285 - Non-active surgical implants
Current Stage
4599 - Dispatch of FV draft to CMC - Finalization for Vote
Start Date
27-Nov-2024
Completion Date
27-Nov-2024
Ref Project
SIST EN ISO 5840-3:2021/oprA1:2024 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840 3:2021/DAM 1:2024)

Relations

Amends
EN ISO 5840-3:2021 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021)
Effective Date
22-Nov-2023

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EN ISO 5840-3:2021/oprA1:2024EN ISO 5840-3:2021/oprA1:2024
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EN ISO 5840-3:2021/oprA1:2024
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Standards Content (Sample)


SLOVENSKI STANDARD
01-april-2024
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/DAM 1:2024)
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes
implanted by transcatheter techniques - Amendment 1 (ISO 5840 3:2021/DAM 1:2024)
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 3: Durch Minimal-Invasive
Methoden Implantierter Herzklappenersatz - Änderung 1 (ISO 5840 3:2021/DAM 1:2024)
Implants cardiovasculaires - Prothèses valvulaires - Partie 3: Valves cardiaques de
substitution implantées par des techniques transcathéter - Amendement 1 (ISO 5840
3:2021/DAM 1:2024)
Ta slovenski standard je istoveten z: EN ISO 5840-3:2021/prA1
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.

DRAFT
Amendment
ISO 5840-3:2021/
DAM 1
ISO/TC 150/SC 2
Cardiovascular implants — Cardiac
Secretariat: ANSI
valve prostheses —
Voting begins on:
Part 3:
2024-02-06
Heart valve substitutes implanted
Voting terminates on:
by transcatheter techniques 2024-04-30
AMENDMENT 1
Implants cardiovasculaires — Prothèses valvulaires —
Partie 3: Valves cardiaques de substitution implantées par des
techniques transcathéter
AMENDEMENT 1
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO 5840-3:2021/DAM 1:2024(en)
DRAFT
ISO 5840-3:2021/DAM 1:2024(en)
Amendment
ISO 5840-3:2021/
DAM 1
ISO/TC 150/SC 2
Cardiovascular implants — Cardiac
Secretariat: ANSI
valve prostheses —
Voting begins on:
Part 3:
Heart valve substitutes implanted
Voting terminates on:
by transcatheter techniques
AMENDMENT 1
Implants cardiovasculaires — Prothèses valvulaires —
Partie 3: Valves cardiaques de substitution implantées par des
techniques transcathéter
AMENDEMENT 1
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO 5840-3:2021/DAM 1:2023(en)
ii
ISO 5840-3:2021/DAM 1:2023(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives,
...

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