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

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)

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)

General Information

• Status: Not Published
• Public Enquiry End Date: 30-Jul-2024
• ICS: 01.080.20 - Graphical symbols for use on specific equipment
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 03-Jun-2024
• Due Date: 21-Oct-2024
• Ref Project: EN ISO 15223-1:2021/prA1 - 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)

Relations

• Amends: SIST EN ISO 15223-1:2021 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
• Effective Date: 28-Dec-2022

Standards Content (Sample)

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.
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 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.
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 15223-1:2021/DAM 1:2024(en)
ii
ISO 15223-1:2021/DAM 1:2024(en)
Foreword
ISO (the Internat
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