SIST EN ISO 11608-3:2022/A1:2026

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/Amd 1:2026)

General Information

• Status: Published
• Public Enquiry End Date: 30-Oct-2025
• Publication Date: 17-May-2026
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 07-May-2026
• Due Date: 12-Jul-2026
• Completion Date: 18-May-2026
• Ref Project: 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)

Relations

• Amends: SIST 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)
• Effective Date: 01-Jun-2026

Overview

SIST EN ISO 11608-3:2022/kFprA1:2026 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
01-junij-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/Amd 1:2026)
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)
Ta slovenski standard je istoveten z: EN ISO 11608-3:2022/A1:2026
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.

EN ISO 11608-3:2022/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2026
EUROPÄISCHE NORM
ICS 11.040.25
English Version
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)
Systèmes d'injection à aiguille pour usage médical - Kanülenbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 3: Conteneurs et Verwendung - Anforderungen und Prüfverfahren - Teil
chemins de fluide intégrés - Amendement 1 (ISO 3: Behälter und integrierte Flüssigkeitsbahnen -
11608-3:2022/Amd 1:2026) Änderung 1 (ISO 11608-3:2022/Amd 1:2026)
This amendment A1 modifies the European Standard EN ISO 11608-3:2022; it was approved by CEN on 27 April 2026.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11608-3:2022/A1:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11608-3:2022/A1:2026) has been prepared by Technical Committee ISO/TC 84
"Devices for administration of medicinal products and catheters" in collaboration with Technical
Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
This Amendment to the European Standard EN ISO 11608-3:2022 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by October 2026,
and conflicting national standards shall be withdrawn at the latest by October 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 11608-3:2022/Amd 1:2026 has been approved by CEN as EN ISO 11608-
3:2022/A1:2026 without any modification.

International
Standard
ISO 11608-3
Third edition
Needle-based injection systems for
2022-04
medical use — Requirements and
test methods —
AMENDMENT 1
2026-04
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
Reference number
ISO 11608-3:2022/Amd.1:2026(en) © ISO 2026

ISO 11608-3:2022/Amd.1:2026(en)
© ISO 2026
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 11608-3:2022/Amd.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/Amd.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
...