ISO 11608-1:2022/FDAmd 1

ISO 11608-1:2022/DAMFDAmd 1:2025(en)
ISO/TC 84/WG 3 N 723
Replaces N 722
Secretariat: DS
Date: 2025-12-152026-01-09
Needle-based injection systems for medical use — Requirements and
test methods —
Part 1:
Needle-based injection systems
AMENDMENT 1
Systèmes d'injection à aiguille pour usage médical — Exigences et méthodes d'essai — —
Partie 1: Systèmes d'injection à aiguille
AMENDEMENT 1
TTTTTTTThhhhhhhhiiiiiiiis drs drs drs drs drs drs drs draaaaaaaafffffffftttttttt i i i i i i i is s s s s s s s susususususususubbbbbbbbmimmmmmmmiiiiiiitttttttttttttttteeeeeeeed d d d d d d d ttttttttoooooooo    aaaaaaaa    ppppppppaaaaaaaarrrrrrrraaaaaaaallellellellellellellellel l l l l l l l vvvvvvvvooooooootttttttteeeeeeee i i i i i i i innnnnnnn    IIIIIIIISSSSSSSSOOOOOOOO,,,,,,,,    CCCCCCCCEEEEEEEEN.N.N.N.N.N.N.N.

ISO #####-#:####(X)
FDIS stage
© ISO #### – All rights reserved

ISO 11608-1:2022/DAMFDAmd 1:2025(en)
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
iii
ISO #####-#:####(X 11608-1:2022/FDAmd 1(en)
Contents
© ISO #### 2026 – All rights reserved
iv
ISO 11608-1:2022/DAMFDAmd 1:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of
ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO'sISO’s adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and catheters, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 11608 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
ISO 11608-1:2022/DAM 1:2025(en)
Needle-based injection systems for medical use — Requirements and
test methods — —
Part 1:
Needle-based injection systems
AMENDMENT 1
5.7.2  Primary functions requirements
Replace the first paragraph with the following:
Primary functions shall be identified through an assessment of each design specification (see Figure H.2
for an example assessment process). At minimum, primary functions shall include the dose delivery
function, as specified by the dose accuracy requirements.

6.1 General
Replace the first paragraph and the NOTE with the following:
Any suitable test system can be used for the measurement of primary functions of the NIS, when the

required accuracy (calibration) and precision (Gauge R&R) can be obtained. The repeatability and
reproducibility (Gauge R&R) of the test apparatus shall be no greater than 20 % of the specification range
for any given measurement. For one-sided specifications, the other endpoint shall be established to create
a specification range for the assessment of the apparatus (i.e. not as a specification limit). For destructive
test measurements, the Gauge R&R shall be no greater than 30 % of the specification range. At a
minimum, the Gauge R&R should cover ±2 standard deviations (thereby covering approximately 95 % of
the variation).
NOTE     An extra endpoint for one-sided specifications can be based on physical limitations of the NIS or the
measurement system (e.g. noting that a duration of time cannot be negative), or be based on the distribution of
the measurement results (e.g. setting the end-point six times the standard deviation from the mean).
NOTE An extra endpoint for one-sided specifications can be based on physical limitations of
the NIS or the measurement system (e.g. noting that a duration of time cannot be negative), or it can be
based on the distribution of the measurement results (e.g. setting the end-point six times the standard
deviation from the mean).
7.2.2  Dosing regions
Replace NOTE 1 with:
NOTE 1 If the sum of the doses set is greater than or equal to half the deliverable volume of the
container, the container can be divided i
...