EN ISO 5840-1:2021/FprA1:2024

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements - Amendment 1 (ISO 5840-1:2021/FDAmd1:2024)

Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 1: Allgemeine Anforderungen - Änderung 1 (ISO 5840-1:2021/FDAmd 1:2024)

Implants cardiovasculaires - Prothèses valvulaires - Partie 1: Exigences générales - Amendement 1 (ISO 5840-1:2021/FDAmd1:2024)

Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 1. del: Splošne zahteve - Dopolnilo A1 (ISO 5840-1:2021/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 5840-1:2021/oprA1:2024 - Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements - Amendment 1 (ISO 5840-1:2021/DAM 1:2024)

Relations

• Amends: EN ISO 5840-1:2021 - Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021)
• Effective Date: 22-Nov-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2024
Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 1. del: Splošne
zahteve - Dopolnilo A1 (ISO 5840-1:2021/DAM 1:2024)
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements -
Amendment 1 (ISO 5840-1:2021/DAM 1:2024)
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 1: Allgemeine Anforderungen -
Änderung 1 (ISO 5840-1:2021/DAM 1:2024)
Implants cardiovasculaires - Prothèses valvulaires - Partie 1: Exigences générales -
Amendement 1 (ISO 5840-1:2021/DAM 1:2024)
Ta slovenski standard je istoveten z: EN ISO 5840-1:2021/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 5840-1:2021/
DAM 1
ISO/TC 150/SC 2
Cardiovascular implants — Cardiac
Secretariat: ANSI
valve prostheses —
Voting begins on:
Part 1:
2024-02-07
General requirements
Voting terminates on:
2024-05-01
AMENDMENT 1
Implants cardiovasculaires — Prothèses valvulaires —
Partie 1: Exigences générales
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 5840-1:2021/DAM 1:2024(en)
DRAFT
ISO 5840-1:2021/DAM 1:2024(en)
Amendment
ISO 5840-1:2021/
DAM 1
ISO/TC 150/SC 2
Cardiovascular implants — Cardiac
Secretariat: ANSI
valve prostheses —
Voting begins on:
Part 1:
General requirements
Voting terminates on:
AMENDMENT 1
Implants cardiovasculaires — Prothèses valvulaires —
Partie 1: Exigences générales
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: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO 5840-1:2021/DAM 1:2023(en)
ii
ISO 5840-1:2021/DAM 1:2023(en)
Foreword
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The procedures used to develop this document and those intended for its further maintenance are described
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This document was prepared by ISO/TC 150, Implants for surgery, Subcommittee 2, Cardiovascular implants
and extracorporeal system.
The main changes are as follows:
— Corrections and clarifications to ISO 5840-1:2021
A list of all parts in the ISO 5840 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iii
ISO 5840-1:2021/DAM 1:2023(en)
Cardiovascular implants — Cardiac valve prostheses —
Part 1:
General requirements
AMENDMENT 1
Terms and definitions
3.1
Replace the definition of accessory with the
...