ISO 23217:2024
(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
This document provides requirements and guidelines on the development of drug delivery systems intended for self-administration of medicinal products by the specific demographic group of paediatric patients who are performing some or all use steps required for their intended use. Use steps include any handling action performed after the patient has received the product; these can include but are not limited to: — transport – carrying the product while travelling (e.g. by walking, train, airplane, automobile, bus); — storage – storage by the patient in their home, school, office or in temporary storage cases before or between uses; — preparation – steps necessary to place the product in a state where it is ready to be administered; — operation – steps necessary to initiate, adjust, pause, stop, or otherwise manage the delivery of medication using the product; — maintenance – steps necessary to keep the product in good working order; — disposal – steps to ensure safe disposal of the product after use (e.g. placement of the product in a suitable receptacle). This document is applicable to injectable drug delivery systems for administration of medicinal products. Furthermore, this document can be useful for the development of other drug delivery devices or systems if they are intended for use by the paediatric population. Devices not in the scope of this document include catheters, for example those in the scope of ISO 10555 series, and infusion pump systems, e.g. IEC 60601-2-24 and aerosol delivery devices (ISO 20072).
Systèmes d'injection pour auto-administration par des patients pédiatriques — Exigences et lignes directrices relatives à la conception
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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
...
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