EN ISO 11608-3:2022/prA1:2025
(Amendment)Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths - Amendment 1 (ISO 11608-3:2022/DAmd1:2025)
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths - Amendment 1 (ISO 11608-3:2022/DAmd1:2025)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 3: Conteneurs et chemins de fluide intégrés - Amendement 1 (ISO 11608-3:2022/DAmd 1:2025)
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 3. del: Vsebniki in integrirane fluidne poti - Dopolnilo A1 (ISO 11608-3:2022/DAmd1:2025)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2025
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 3. del:
Vsebniki in integrirane fluidne poti - Dopolnilo A1 (ISO 11608-3:2022/DAmd1:2025)
Needle-based injection systems for medical use - Requirements and test methods - Part
3: Containers and integrated fluid paths - Amendment 1 (ISO 11608-
3:2022/DAmd1:2025)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 3: Conteneurs et chemins de fluide intégrés - Amendement 1 (ISO 11608-
3:2022/DAmd 1:2025)
Ta slovenski standard je istoveten z: EN ISO 11608-3:2022/prA1:2025
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
Amendment
ISO 11608-3:2022/
DAM 1
ISO/TC 84
Needle-based injection systems for
Secretariat: DS
medical use — Requirements and
test methods —
Voting begins on:
2025-08-18
Part 3:
Voting terminates on:
Containers and integrated fluid 2025-11-10
paths
AMENDMENT 1
Systèmes d'injection à aiguille pour usage médical — Exigences
et méthodes d'essai —
Partie 3: Conteneurs et chemins de fluide intégrés
AMENDEMENT 1
ICS: 11.040.25
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 11608-3:2022/DAM 1:2025(en)
DRAFT
ISO 11608-3:2022/DAM 1:2025(en)
Amendment
ISO 11608-3:2022/
DAM 1
ISO/TC 84
Needle-based injection systems for
Secretariat: DS
medical use — Requirements and
test methods —
Voting begins on:
Part 3:
Voting terminates on:
Containers and integrated fluid paths
AMENDMENT 1
Systèmes d'injection à aiguille pour usage médical — Exigences
et méthodes d'essai —
Partie 3: Conteneurs et chemins de fluide intégrés
AMENDEMENT 1
ICS: 11.040.25
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 2025
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
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TO SUBMIT, WITH THEIR COMMENTS,
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PROVIDE SUPPORTING DOCUMENTATION.
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Website: www.iso.org
Published in Switzerland Reference number
ISO 11608-3:2022/DAM 1:2025(en)
ii
ISO 11608-3:2022/DAM 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.
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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'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.
This amendment addresses errors and inconsistencies regarding the identification and assessment of visible
particulates appropriate for the safe and effective delivery routes covered by the ISO 11608 series. It also
includes a new informative Annex (Annex G) that provides explanation and justification for the change to
the particulate requirements for NISs.
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.
iii
ISO 11608-3:2022/DAM 1:2025(en)
Needle-based injection systems for medical use —
Requirements and test methods —
Part 3:
Containers and integrated fluid paths
AMENDMENT 1
4.5.3.1 General
Replace the subclause with the following:
The reservoir and/or integrated fluid path shall be assessed for sub-visible and visible particulate matter.
Applicable pharmacopeia establishes limits for the size and number of particulates allowed for the
medicinal product. Manufacturers shall establish design specifications for particulate matter limits
from the reservoir and/or fluid path based on risk assessment.
It is recommended that the manufacturer and its suppliers agree upon the test methods to be used and
the size and number of sub-visible and visible particulates permissible for the NIS.
Particulates from the NIS, which, due to their size, nature and/or quantity interfere with the function
of the NIS or have a negative impact to patient safety, shall not be acceptable.
NOTE The impact of any particulates on the function of the NIS can be assessed through dose accuracy
testing.
4.5.3.2 Sub-visible
Delete “for example” in the fourth line and update dated reference:
Unless otherwise justified, limits for the NIS reservoir and/or integrated fluid path shall be:
— Particles ≥10 µm: 600 max. per NIS;
— Particles ≥25 µm: 60 max. per NIS;
when tested in accordance with the method described in 5.3.
NOTE These above listed limits are taken from ISO 11040-4:2024.
4.5.3.3 Visible
Replace the subclause with the following:
Visible particulate matter (>150 µm in diameter) other than fragments generated during disc
penetration (which are addressed in 4.2.3) delivered from the NIS reservoir and/or integrated fluid
path when flushed with particle free water in accordance with the method described in 5.4, shall be
minimized such that any visible particulates present do not interfere with the function of the NIS or
have a negative impact on patient safety due to their nature and/or quantity.
ISO 11608-3:2022/DAM 1:2025(en)
Annex A
Change Lines 1 and 3 in Table A.1 to read:
Table A
...
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