EN ISO 11608-1:2022/A1:2026

• Status: Published
• Publication Date: 05-May-2026
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 06-May-2026
• Completion Date: 06-May-2026
• Ref Project: SIST EN ISO 11608-1:2022/A1:2026 - Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems - Amendment 1 (ISO 11608-1:2022/Amd1:2026)

• Consolidated By: ISO 11608-1:2022/Amd 1:2026 - Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems — Amendment 1
• Effective Date: 12-Feb-2026
• Amends: EN ISO 11608-1:2022 - Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022)
• Effective Date: 16-Oct-2024

Overview

EN ISO 11608-1:2022/A1:2026 is the latest amendment to the standard for needle-based injection systems (NIS) for medical use, specifically focusing on part 1: requirements and test methods. Published by CEN and developed through collaboration with ISO and technical committee ISO/TC 84, this amendment enhances the clarity and consistency of terminology and updates procedural details related to the testing and evaluation of injection systems. The amendment ensures alignment and precision across documentation, improving how manufacturers and stakeholders approach terminology, inspection, and performance verification for medical injection devices.

Key Topics

• Terminology Consistency: Editorial inconsistencies are addressed, ensuring uniform use of terms such as “anticipated/normal conditions,” “in-use conditions,” “conditioning,” and “preconditioning.”

• Primary Function Identification: Clarified guidelines require the identification of primary functions via assessment of design specifications, emphasizing dose delivery and accuracy.

• Test Methods and Apparatus Requirements: Updated requirements for measurement systems specify accuracy, precision, repeatability, and reproducibility, particularly for high-precision test apparatus used in NIS evaluation.

• Dosing Regions Procedures: Revised notes provide clearer guidance for dividing container contents for dosing evaluation, supporting more accurate system testing.

• Test Case Matrix: The amendment summarizes required tests under different conditions and outlines the sequence for visual inspections and primary function assessments.

• Verification Under Varying Conditions: The amendment strengthens requirements for conducting inspections and assessments both after stressed/challenge conditions and under normal/anticipated conditions.

• Life-cycle and Functional Stability: Life-cycle testing now applies a defined safety factor, and “functional stability” encompasses both shelf-life and in-use life, underscoring the importance of system reliability from manufacture to disposal.

• Risk and Harm Assessment: The amendment clarifies the distinction between evaluating essential performance based on both likelihood and severity of harm, and identifying primary functions based solely on severity.

Applications

This standard amendment is essential for:

• Medical Device Manufacturers: Helps in the development and production of reliable, safe needle-based injection systems such as insulin pens, prefilled syringes, and auto-injectors. The clarified requirements improve the accuracy of design verification and validation processes.

• Regulatory Compliance: Provides a harmonized reference for demonstrating conformity with European and international regulatory requirements, streamlining pathways for product approval and market access.

• Quality Assurance and Testing Laboratories: Enables testing bodies to implement robust, reproducible, and compliant methods for product evaluation, ensuring consistent performance and safety over the product’s lifecycle.

• Healthcare Providers and End-Users: Enhances confidence in the reliability and safety of injection systems, minimizing risks associated with dosing inaccuracies or device failure.

Related Standards

For a comprehensive approach to needle-based injection system safety and performance, consider the following related standards:

• ISO 11608 Series: Covers additional requirements for accessories, drug containers, pen-injectors, and more.
• EN ISO 23908: Focuses on sharps injury protection for medical devices.
• ISO 14971: Medical devices - Application of risk management to medical devices.
• ISO 10993 Series: Biocompatibility evaluation of medical device materials.

By adopting EN ISO 11608-1:2022/A1:2026, stakeholders support consistent terminology, thorough testing, and enhanced safety for needle-based injection systems, ensuring better protection for patients and healthcare professionals.

SLOVENSKI STANDARD
01-julij-2026
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 1. del:
Peresa za injiciranje - Dopolnilo A1 (ISO 11608-1:2022/Amd1:2026)
Needle-based injection systems for medical use - Requirements and test methods - Part
1: Needle-based injection systems - Amendment 1 (ISO 11608-1:2022/Amd1:2026)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 1: Kanülenbasierte Injektionssysteme - Änderung 1 (ISO 11608-
1:2022/Amd1:2026)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 1: Systèmes d'injection à aiguille - Amendement 1 (ISO 11608-
1:2022/Amd1:2026)
Ta slovenski standard je istoveten z: EN ISO 11608-1:2022/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 11608-1:2022/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2026
EUROPÄISCHE NORM
ICS 11.040.25
English Version
Needle-based injection systems for medical use -
Requirements and test methods - Part 1: Needle-based
injection systems - Amendment 1 (ISO 11608-
1:2022/Amd1:2026)
Systèmes d'injection à aiguille pour usage médical - Kanülenbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 1: Systèmes Verwendung - Anforderungen und Prüfverfahren - Teil
d'injection à aiguille - Amendement 1 (ISO 11608- 1: Kanülenbasierte Injektionssysteme - Änderung 1
1:2022/Amd1:2026) (ISO 11608 1:2022/Amd 1:2026)
This amendment A1 modifies the European Standard EN ISO 11608-1:2022; it was approved by CEN on 24 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 11608-1:2022/A1:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11608-1:2022/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 European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2026, and conflicting national standards
shall be withdrawn at the latest by November 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 11608-1:2022/Amd 1:2026 has been approved by CEN as EN ISO 11608-
1:2022/A1:2026 without any modification.

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

ISO 11608-1:2022/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
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ISO copyright office
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Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 11608-1:2022/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,
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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 convenien
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