EN ISO 11608-3:2022/A1:2026

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths - Amendment 1 (ISO 11608-3:2022/Amd 1:2026)

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 3: Behälter und integrierte Flüssigkeitsbahnen - Änderung 1 (ISO 11608-3:2022/Amd 1:2026)

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/Amd 1:2026)

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 3. del: Vsebniki in integrirane fluidne poti - Dopolnilo A1 (ISO 11608-3:2022/FDAmd1:2026)

General Information

• Status: Not Published
• Publication Date: 28-Apr-2026
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 11 - Transfusion, infusion and injection equipment
• Current Stage: 6055 - CEN Ratification completed (DOR) - Publishing
• Start Date: 27-Apr-2026
• Completion Date: 27-Apr-2026
• Ref Project: SIST EN ISO 11608-3:2022/kFprA1:2026 - Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths - Amendment 1 (ISO 11608-3:2022/FDAmd1:2026)

Relations

• Consolidated By: ISO 11608-3:2022/Amd 1:2026 - Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths — Amendment 1
• Effective Date: 12-Feb-2026
• Amends: EN ISO 11608-3:2022 - Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01)
• Effective Date: 18-Jun-2025

Overview

EN ISO 11608-3:2022/A1:2026 specifies updated requirements and test methods for containers and integrated fluid paths in needle-based injection systems (NIS) for medical use. Issued by CEN as an amendment to ISO 11608-3:2022, this standard focuses on the assessment and management of particulate matter within the reservoir and fluid path, with a sustained emphasis on patient safety and product functionality. The document addresses harmonization with relevant pharmacopoeial standards and incorporates a new Annex to clarify particulate requirements and their underlying rationale.

Key Topics

• Particulate Matter Requirements:

  • Updates criteria for both sub-visible and visible particulates in the NIS reservoir and fluid path.
  • Sets maximum limits for sub-visible particles per device, referencing ISO 11040-4.
  • Calls for risk-based determination of limits adapted to product design and end-use.

• Visual and Sub-Visual Particulate Limits:

  • Sub-visible: Strict numeric limits for particles ≥10 µm and ≥25 µm.
  • Visible: Mandates minimization and assessment to ensure particulates do not interfere with device function or patient safety.

• Design Verification & Risk Assessment:

  • Manufacturers must validate particulate controls through design verification, not routine lot release, emphasizing risk assessment tailored to intended use and patient population.

• Control Strategies:

  • Detailed approaches for environmental, supplier, and component controls.
  • Periodic re-verification after design changes or process adjustments.

• Harmonization:

  • Cross-references key pharmacopeial and related ISO standards, aligning test methods and specifications for medicinal product safety and compatibility.

Applications

This standard is vital for manufacturers and suppliers of needle-based injection systems, including pen injectors, auto-injectors, and similar drug delivery devices. Key practical applications include:

• Product Development:

  • Ensuring new devices meet up-to-date particulate control and safety benchmarks.
  • Supporting risk management throughout the design phase to minimize particulates.

• Quality Assurance:

  • Implementing appropriate test methods for particulate assessment in compliance with international guidelines.
  • Creating control programs for manufacturing processes to sustain environmental cleanliness and supplier conformity.

• Regulatory Compliance:

  • Demonstrating adherence to harmonized international standards, which can strengthen submissions to authorities and enable market access.

• Patient Safety:

  • Minimizing risks associated with particulate contamination in injectable therapies, especially for vulnerable patient groups.

This amendment provides essential guidance for both technical and regulatory teams responsible for ensuring the safety and efficacy of injection systems, helping foster reliable medical products and improved patient outcomes.

Related Standards

• ISO 11608 Series: General requirements for needle-based injection systems.
• ISO 11040-4: Prefilled glass syringes-test methods and specifications for sub-visible particulate matter.
• ISO 8536-4: Infusion sets for medical use-requirements for particulate matter.
• USP <788>, <790>, <1790>: US Pharmacopeia test methods and guidelines for particulate matter in injections.
• ICH Q3D, M7: International guidelines addressing elemental and mutagenic impurities in pharmaceuticals.

For manufacturers and stakeholders, familiarity with these related standards supports integrated compliance and robust product development strategies aligned with global best practices in medical device and medicine administration safety.

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11608-3:2022/oprA1:2025
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
SIST EN ISO 11608-3:2022/oprA1:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN ISO 11608-3:2022/oprA1:2025

SIST EN ISO 11608-3:2022/oprA1:2025
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)

SIST EN ISO 11608-3:2022/oprA1:2025
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
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO 11608-3:2022/DAM 1:2025(en)

ii
SIST EN ISO 11608-3:2022/oprA1:2025
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.
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'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
SIST EN ISO 11608-3:2022/oprA1:2025

SIST EN ISO 11608-3:2022/oprA1:2025
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.

SIST EN ISO 11608-3:2022/oprA1:2025
ISO 11608-3:2022/DAM 1:2025(en)

Annex A
Change Lines 1 and 3 in Table A.1 to read:
Table A
...