SIST EN ISO 11608-1:2022/A1:2026

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)

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 1. del: Peresa za injiciranje - Dopolnilo A1 (ISO 11608-1:2022/Amd1:2026)

General Information

• Status: Published
• Public Enquiry End Date: 29-Sep-2025
• Publication Date: 20-May-2026
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 15-May-2026
• Due Date: 20-Jul-2026
• Completion Date: 21-May-2026
• Ref Project: 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)

Relations

• Amends: SIST 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: 01-Jul-2026

Overview

SIST EN ISO 11608-1:2022/A1:2026 is an international amendment standard specifying requirements and test methods for needle-based injection systems (NIS) used in medical settings. This amendment aligns with ISO 11608-1:2022/Amd1:2026 and has been harmonized across European standards, enhancing consistency and patient safety in the design, performance, and testing of injection pens and similar devices.

The standard is a crucial reference for manufacturers, regulators, and medical device professionals involved in the development, assessment, and approval of NIS for healthcare applications. With a strong focus on functional stability, measurement accuracy, and proper test procedures, this amendment provides a rigorous framework to verify that medical injection systems reliably deliver their intended therapeutic functions throughout their defined lifecycle.

Key Topics

• Primary Functions Definition
  The standard clarifies that all essential performance functions required for safety and effectiveness, particularly dose delivery and dose accuracy, must be identified early in the design phase and stringently verified during testing.

• Test Methods and Equipment
  Detailed requirements establish that primary functions should be tested using suitably calibrated and precise systems. Gauge R&R (Repeatability and Reproducibility) for test apparatus is specified to ensure credible measurement results, with clear limits for acceptable variability.

• Lifecycle and Functional Stability
  The amendment mandates that needle-based injection systems retain their functionality not only throughout their anticipated in-use period but also after exposure to stress conditions (such as transport simulation or environmental challenges) and at the end of their shelf-life.

• Inspection and Testing Sequences
  Comprehensive guidance is provided for performing inspections and functional tests after subjecting devices to stressed or normal conditions, simulating real-world handling and use, and ensuring safety before patient administration.

• Risk Assessment Process
  Enhanced procedures outline how to distinguish between primary functions (associated with unacceptable harm severity) and essential performance (considering both harm probability and severity), framing a robust approach to risk management in medical device development.

Applications

This standard is applied across the lifecycle of needle-based injection systems, with practical benefits including:

• Medical Device Development: Guiding design teams in identifying critical system functions and validating device performance under both normal and stressed conditions.
• Regulatory Compliance: Supporting conformity with European and international regulations for non-active medical devices, facilitating market access and patient safety.
• Quality Assurance: Ensuring that NIS products consistently meet defined requirements for functional stability, dose accuracy, and usability throughout their labeled shelf-life and in-use duration.
• Testing Laboratories: Providing detailed instructions for configuring test environments, calibrating equipment, and performing comprehensive product verification.
• Risk Management: Enabling a structured assessment of design and operational risks to mitigate potential harm associated with NIS failures or inaccuracies.

Related Standards

• ISO 11608 Series: This amendment is part of the broader ISO 11608 family, which addresses various aspects of needle-based injection systems, including component compatibility and electronic controls.
• EN ISO 11608-1:2022: The base standard specifying requirements and testing for NIS, with which this amendment must be used.
• ISO 14971: Standard for the application of risk management to medical devices, often referenced when identifying and mitigating risks highlighted in ISO 11608-1.
• CEN/TC 205 Standards: Additional European standards for non-active medical devices, supporting harmonization and safe use across clinical settings.

By integrating SIST EN ISO 11608-1:2022/A1:2026 into product development and compliance processes, stakeholders contribute to higher safety, reliability, and clinical effectiveness of medical injection systems used in patient care.

Key SEO terms: needle-based injection systems, medical injection pens standard, ISO 11608-1, requirements for NIS, test methods for medical devices, functional stability, dose accuracy, non-active medical devices, regulatory compliance, risk management.

Standards Content (Sample)

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
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
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Phone: [phone]
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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