SIST EN ISO 15223-1:2021/oprA1:2024

SLOVENSKI STANDARD
01-julij-2024
Medicinski pripomočki - Simboli za označevanje podatkov, ki jih mora zagotoviti
dobavitelj - 1. del: Splošne zahteve - Dopolnilo 1: Dodajanje opredeljenega izraza
za pooblaščenega zastopnika in sprememba simbola EC REP, ne da bi bil ta vezan
na točno določeno državo ali regijo (ISO 15223 1:2021/DAM 1:2024)
Medical devices - Symbols to be used with information to be supplied by the
manufacturer - Part 1: General requirements - Amendment 1: Addition of defined term for
authorized representative and Modified EC REP symbol to not be country or region
specific (ISO 15223 1:2021/DAM 1:2024)
Medizinprodukte - Symbole zur Verwendung im Rahmen der vom Hersteller
bereitzustellenden Informationen - Teil 1: Allgemeine Anforderungen - Änderung 1 (ISO
15223 1:2021/DAM 1:2024)
Dispositifs médicaux - Symboles à utiliser avec les informations à fournir par le fabricant
- Partie 1: Exigences générales - Amendement 1: Ajout du terme défini représentant
autorisé (mandataire) et modification du symbole EC REP pour ne pas être spécifique
d’un pays ou d’une région (ISO 15223 1:2021/DAM 1:2024)
Ta slovenski standard je istoveten z: EN ISO 15223-1:2021/prA1
ICS:
01.080.20 Grafični simboli za posebno Graphical symbols for use on
opremo specific equipment
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
Amendment
ISO 15223-1:2021/
DAM 1
ISO/TC 210
Medical devices — Symbols to
Secretariat: ANSI
be used with information to be
supplied by the manufacturer —
Voting begins on:
2024-05-23
Part 1:
Voting terminates on:
General requirements 2024-08-15
AMENDMENT 1: Addition of defined
term for authorized representative
and Modified EC REP symbol to not be
country or region specific
ICS: 01.080.20; 11.040.01
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.
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RECIPIENTS OF THIS DRAFT ARE INVITED
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Reference number
ISO 15223-1:2021/DAM 1:2024(en)
DRAFT
ISO 15223-1:2021/DAM 1:2024(en)
Amendment
ISO 15223-1:2021/
DAM 1
ISO/TC 210
Medical devices — Symbols to
Secretariat: ANSI
be used with information to be
supplied by the manufacturer —
Voting begins on:
Part 1:
Voting terminates on:
General requirements
AMENDMENT 1: Addition of defined
term for authorized representative
and Modified EC REP symbol to not be
country or region specific
ICS: 01.080.20; 11.040.01
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.
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PROVIDE SUPPORTING DOCUMENTATION.
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Website: www.iso.org
Published in Switzerland Reference number
ISO 15223-1:2021/DAM 1:2024(en)
ii
ISO 15223-1:2021/DAM 1:2024(en)
Foreword
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