ISO 23217
(Main)Injection systems for self-administration by paediatric patients — Requirements and guidelines for design
Injection systems for self-administration by paediatric patients — Requirements and guidelines for design
Systèmes d'injection pour auto-administration par des patients pédiatriques — Exigences et lignes directrices relatives à la conception
General Information
Relations
Buy Standard
Standards Content (Sample)
FINAL
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: copyright@iso.org
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
---------------------- Page: 2 ----------------------
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 .
...
ISO/DIS FDIS 23217.2:2023(E)
ISO/TC 84/WG 16 N 147
Replaces: N 146
Secretariat: DS
Date: 2023-06-1510-31
Injection systems for self-administration by paediatric patients —
Guidelines — Requirements and guidelines for design
Systèmes d'injection pour auto-administration par des patients pédiatriques — Recommandations de —
Exigences et lignes directrices relatives à la conception
This document contains the result of the check for obvious editorial errors after the meeting in
Washington in June 2023 on ISO/DIS 23217.2.
The comments with Secretariat observations are circulated as document N 145 and a track changes
version of this draft is circulated as N 146.
Project leader: Keith Marin (US)
Next step: Document N 147 will be sent to ISO/CS for initiation of the FDIS procedure.
FDIS stage
---------------------- Page: 1 ----------------------
ISO/DISFDIS 23217.2:2023(E) (N 147)
© 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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2023 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/DISFDIS 23217.2:2023(E) (N 147)
Contents
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 . 6
4.2.1 Risk assessment . 6
4.2.2 Usability engineering . 6
4.3 Considerations for the determination of requirements for the design of medical devices specific to
paediatric users . 6
4.3.1 Considerations in relation to risk (risk-based approach to design) . 6
4.3.2 Considerations in relation to human factors . 6
4.3.3 Considerations for accompanying documentation . 14
5 Development of the design . 14
6 Design verification and validation . 15
6.1 General . 15
6.2 Design verification . 15
6.3 Design validat
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.