ISO 11608-3:2022/FDAmd 1
(Amendment)Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths — Amendment 1
Needle-based injection systems for medical use — Requirements and test methods — Part 3: 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
General Information
- Status
- Not Published
- Technical Committee
- ISO/TC 84 - Devices for administration of medicinal products and catheters
- Current Stage
- 5000 - FDIS registered for formal approval
- Start Date
- 19-Dec-2025
- Completion Date
- 02-Mar-2026
Relations
- Effective Date
- 14-Jun-2025
Overview
ISO 11608-3:2022/FDAmd 1 is an important international standard specifying requirements and test methods for needle-based injection systems (NIS) used in medical applications, focusing specifically on containers and integrated fluid paths. This amendment updates and refines the criteria for fluid delivery components in injection devices, emphasizing particulate matter limits to ensure patient safety and device reliability.
Developed by ISO Technical Committee ISO/TC 84 in conjunction with CEN/TC 205, the standard aligns with global regulatory expectations and harmonizes testing protocols for injectable medical devices. It addresses risk management, design verification, and control strategies related to particulates in the fluid path, ensuring safer drug delivery.
Key Topics
Particulate Matter Requirements
The standard defines limits for both visible and sub-visible particulates in reservoirs and fluid paths of needle-based injection systems, referencing pharmacopeial guidelines and ISO 11040 series.- Sub-visible particulate limits:
- ≥10 µm: Maximum 600 particles per device
- ≥25 µm: Maximum 60 particles per device
- Visible particulates (>150 µm) must be minimized and prevented if they interfere with device function or patient safety.
- Sub-visible particulate limits:
Risk-Based Approach
Manufacturers are required to assess particulate contamination risk using a risk-based methodology. Design specifications for particulate limits must be established through collaboration between drug and device manufacturers to ensure compatibility.Design Verification and Testing Methods
The amendment introduces rigorous design verification testing for particulate presence, leveraging particle-free water flush methods and pharmacopeial testing procedures such as USP <788>. Testing is part of design validation, not lot release.Patient Safety Considerations
Detailed guidance covers the impact of particulates on patient health, emphasizing biocompatibility, sterility, and administration route relevance. It acknowledges that while particulates may occur, their size, quantity, and nature must not pose a risk, especially in vulnerable populations.Control and Monitoring Strategies
To maintain compliance, manufacturers are guided to implement:- Lot testing protocols during initial and periodic production phases.
- Environmental and supplier process controls to reduce particulate contamination.
- Reverification procedures following design or process changes to maintain particulate limits.
Updated Normative References
ISO 10555-1:2023 replaces the 2013 version, reflecting the latest requirements for intravascular catheter devices, harmonizing standards within medical device sectors.
Applications
ISO 11608-3:2022/FDAmd 1 applies broadly to needle-based injection systems used for subcutaneous, intramuscular, and intradermal drug administration, including:
- Prefilled syringes and cartridges used with reusable or disposable pen injectors
- Integrated reservoirs and fluid paths in autoinjectors and infusion devices
- Medical devices where sterile, particulate-controlled fluid handling is critical for patient safety
The standard supports manufacturers in developing safer, more consistent devices by ensuring the fluid delivery components maintain strict particulate control, thereby reducing risks such as injection site reactions, device malfunction, or potential patient harm.
Related Standards
- ISO 11608 Series – Comprehensive requirements for needle-based injection systems, with Part 1 covering general requirements and Parts 2 and 4 covering needle and injection pen devices respectively.
- ISO 10555-1:2023 – Specifies requirements for intravascular catheters, relevant for soft cannula references and fluid path compatibility.
- USP <788> – United States Pharmacopeia guidance on particulate testing methodologies for injections.
- ISO 11040-4:2024 and ISO 11040-6 – Standards related to prefillable syringe barrels, used as a reference for particulate limits and testing methods.
- ISO 8536-4 – Standard for infusion sets that relates partially to particulate contamination control and testing.
- ICH Guidelines M7(R2) and Q3D(R1) – Guidance on control of impurities and elemental contaminants relevant for risk assessment of particulates.
- ISO/TR 8417 – Risk management framework for particulate contamination in intravascular device access.
For developers and manufacturers of needle-based injection systems, adherence to ISO 11608-3:2022/FDAmd 1 ensures compliance with global safety benchmarks, improving product quality and patient outcomes through meticulous control of particulate matter in medical injection devices.
ISO 11608-3:2022/FDAmd 1 - Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths — Amendment 1 Released:15. 01. 2026
REDLINE ISO 11608-3:2022/FDAmd 1 - Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths — Amendment 1 Released:15. 01. 2026
Frequently Asked Questions
ISO 11608-3:2022/FDAmd 1 is a draft published by the International Organization for Standardization (ISO). Its full title is "Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths — Amendment 1". This standard covers: Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths — Amendment 1
Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths — Amendment 1
ISO 11608-3:2022/FDAmd 1 is classified under the following ICS (International Classification for Standards) categories: 11.040.25 - Syringes, needles an catheters. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 11608-3:2022/FDAmd 1 has the following relationships with other standards: It is inter standard links to ISO 11608-3:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 11608-3:2022/FDAmd 1 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
FINAL DRAFT
Amendment
ISO 11608-3:2022/
FDAM 1
ISO/TC 84
Needle-based injection systems for
Secretariat: DS
medical use — Requirements and
Voting begins on:
test methods —
2026-01-29
Part 3:
Voting terminates on:
2026-03-26
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
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
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING 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.
Reference number
ISO 11608-3:2022/FDAM 1:2026(en) © ISO 2026
FINAL DRAFT
ISO 11608-3:2022/FDAM 1:2026(en)
Amendment
ISO 11608-3:2022/
FDAM 1
ISO/TC 84
Needle-based injection systems for
Secretariat: DS
medical use — Requirements and
Voting begins on:
test methods —
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
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.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO 11608-3:2022/FDAM 1:2026(en) © ISO 2026
ii
ISO 11608-3:2022/FDAM 1:2026(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, 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.
iii
ISO 11608-3:2022/FDAM 1:2026(en)
Needle-based injection systems for medical use —
Requirements and test methods —
Part 3:
Containers and integrated fluid paths
AMENDMENT 1
Clause 2 Normative references
Replace “ISO 10555-1:2013” with “ISO 10555-1:2023”.
4.3.2 Soft cannulas
Replace “ISO 10555-1:2013, 4.6” with “ISO 10555-1:2023, 4.9”.
4.5.3.1 General
Replace the content of 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
Replace the content of the subclause with the following:
Unless otherwise justified, limits for the NIS 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 unless otherwise negotiated with the
drug manufacturer and device manufacturer.
ISO 11608-3:2022/FDAM 1:2026(en)
4.5.3.3 Visible
Replace the content of the subclause with the following:
Visible particulate matter (>150 µm) 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.
Annex A
Change the first and third rows in Table A.1 to read:
Table A.1 — Medicinal product compatibility references
Item Reference Comment
Particulates - Visible Pharmacopoeia standards (USP, PhEur, JP) See Annex G for more guidance
ISO 8536-4
USP<1790>
Particulates - Subvisible Pharmacopoeia standards (USP, PhEur, JP) Use methodology from USP <788> (or
Eur. Ph. 2.9.19, which is harmonized
ISO 8536-4
with other pharmacopoeia) or a meth-
odology similar to ISO 8536-4
Annex G
Add the following new annex after Annex F, before the Bibliography.
ISO 11608-3:2022/FDAM 1:2026(en)
Annex G
(informative)
Particulates in the NIS
G.1 General
This document intentionally differentiates methods of determination and limits for the particulates that are
allowable to be in the NIS from the pharmacopeial requirements that specify the metho
...
ISO 11608-3:2022/DAMFDAmd 1:2025(en)
ISO/TC 84/WG 3 N 726
Replaces N 702
Secretariat: DS
Date: 2025-122026-01-15
Needle-based injection systems for medical use — Requirements and
test methods —
Part 3:
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
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FDIS stage
© ISO #### – All rights reserved
ISO 11608-3:2022/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
Contents
iv
ISO 11608-3:2022/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 11608-3:2022/DAM 1:2025(en)
Needle-based injection systems for medical use — Requirements and
test methods — —
Part 3:
Containers and integrated fluid paths
AMENDMENT 1
Clause 2 Normative references
Replace “ISO 10555-1:2013” with “ISO 10555-1:2023”.
4.3.2 Soft cannulas
Replace “ISO 10555-1:2013, 4.6” with “ISO 10555-1:2023, 4.9”.
4.5.3.1 General
Replace the content of 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
Replace the content of the subclause with the following:
Unless otherwise justified, limits for the NIS 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 unless otherwise negotiated with the drug
manufacturer and device manufacturer.
NOTE These above listed limits are taken from ISO 11040-4:2024 unless otherwise negotiated
with the drug manufacturer and device manufacturer.
4.5.3.3 Visible
Replace the content of the subclause with the following:
Visible particulate matter (>150 µm) 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.
Annex A
Change the first and third rows in Table A.1 to read:
Table A.1 — Medicinal product compatibility references
Item Reference Comment
Particulates - Visible Pharmacopoeia standards (USP, PhEur, See Annex G for more guidance
JP)
ISO 8536-4
USP<1790>
Particulates - Subvisible Pharmacopoeia standards (USP, PhEur, Use methodology from USP <788>
JP) (or Eur. Ph. 2.9.19, which is
harmonized with other
ISO 8536-4
pharmacopoeia) or a methodology
similar to ISO 8536-4
Annex G
Add the following new annex after Annex F, before the Bibliography.
ISO 11608-3:2022/DAMFDAmd 1:2025(en)
Annex G
(informative)
Particulates in the NIS
G.1 General
This document intentionally differentiates methods of determination and limits for the particulates that are
allowable to be in the NIS from the pharmacopeial requirements that specify the methods of determination
and limits for the particulates that are allowable in the medicinal product when stored in its primary container
closure.
The document advises a risk based approach to the establishment of limits for particulates in recognition that,
particularly for visible particulates in NIS products where the reservoir/fluid path designs and manufacturing
processes are more complex and diverse, minimizing them has been, and will continue to be, important; but
elimination of visible particulates is not always possible, practical, or necessary unl
...
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