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INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 23217
ISO/TC 84
Injection systems for self-
Secretariat: DS
administration by paediatric
Voting begins on:
2023-11-15 patients — Requirements and
guidelines for design
Voting terminates on:
2024-01-10
Systèmes d'injection pour auto-administration par des patients
pédiatriques — Exigences et lignes directrices relatives à la
conception
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 23217:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023
---------------------- Page: 1 ----------------------
ISO/FDIS 23217:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 23217
ISO/TC 84
Injection systems for self-
Secretariat: DS
administration by paediatric
Voting begins on:
patients — Requirements and
guidelines for design
Voting terminates on:
Systèmes d'injection pour auto-administration par des patients
pédiatriques — Exigences et lignes directrices relatives à la
conception
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: [email protected]
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/FDIS 23217:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
© ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023
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ISO/FDIS 23217:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Considerations for design inputs .5
4.1 General . 5
4.2 Risk assessment and usability engineering . 5
4.2.1 Risk assessment . 5
4.2.2 Usability engineering . 5
4.3 Considerations for the determination of requirements for the design of medical
devices specific to paediatric users .
...