ISO 13926-1:2026

• Abstract:

  This document specifies the material, performance requirements and labelling, and gives recommendations for shape and dimensions of glass cylinders used in cartridge-type needle-based injection systems (NIS) for medical use, according to ISO 11608-3. This document applies to the glass cylinders as supplied by the manufacturer.

• Status: Published
• Publication Date: 25-Aug-2026
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Drafting Committee: ISO/TC 76/WG 2 - Rigid container systems and related accessories for parenterals and injectables
• Current Stage: 6060 - International Standard published
• Start Date: 26-Aug-2026
• Due Date: 25-Mar-2027
• Completion Date: 26-Aug-2026

• Revises: ISO 13926-1:2018 - Pen systems — Part 1: Glass cylinders for pen-injectors for medical use
• Effective Date: 08-Jul-2024

ISO 13926-1:2026, published by ISO, specifies material, performance and labelling requirements for glass cylinders used in cartridge-type needle-based injection systems (NIS) for medical use. It also gives recommended shapes and dimensions for the cylinders as supplied by the manufacturer. The standard is aimed at manufacturers, customers and others who need cartridge cylinders that can be checked as part of an ISO 11608-3 system.

What does ISO 13926-1:2026 specify?

ISO 13926-1:2026 covers the glass cylinders used in cartridge-type NIS for medical use, including their material, performance, labelling and recommended dimensions. It applies to the cylinders as delivered by the manufacturer, so it is relevant at supply, receiving inspection and component qualification.

The document is organized into Clauses 1 to 7:

• Scope
• Normative references
• Terms and definitions
• Dimensions
• Requirements
• Designation
• Labelling

Figures 1 and 2 show the two flange configurations, and Tables 1 and 2 give the corresponding dimension sets.

What are the key requirements of ISO 13926-1:2026?

ISO 13926-1:2026 focuses on compatibility, material quality, surface condition, hydrolytic resistance, annealing quality and traceable identification. In practice, that means the cylinder has to fit the other cartridge parts, withstand the relevant glass tests and be marked in a way that supports handling and control.

Dimensions and compatibility

The cylinder dimensions are specified by the figures and tables, with separate configurations for cartridge flange and vial flange designs. Lengths l1 and l2 are agreed between manufacturer and customer, while the inner bore dimension d has to work with the selected plunger stopper and seal so the system can be verified in accordance with ISO 11608-3.

The bore depth area may be either cylindrical or slightly conical within the stated limit. That matters because the internal shape affects sealing, movement of the plunger stopper and the overall cartridge fit.

Material and appearance

ISO 13926-1:2026 requires colourless or amber glass of hydrolytic resistance grain glass to ISO 720 - HGA 1, and the glass shall correspond to Type I glass of the relevant pharmacopoeia. The material must not contain seeds or bubbles to an extent that interferes with visual examination of the contents.

A change in glass chemical composition has to be notified to the user at least nine months in advance. This is important for change control, requalification and supply-chain communication.

Performance

The sealing surface shall be flat and free from ripples or undulations. That requirement supports reliable sealing at the end of the cartridge.

Hydrolytic resistance of the internal surface is tested to ISO 4802-1 or ISO 4802-2 and shall meet the HC 1 container class. Before testing, either opening of the cylinder is sealed with a suitable closure element, such as silicone rubber.

After annealing, the maximum residual stress shall not create optical retardation above 40 nm per millimetre of glass thickness when viewed in a strain viewer. The test method is agreed between manufacturer and customer, so the control method should be defined in the quality agreement.

Designation and labelling

The designation combines the standard reference, glass colour, nominal volume, nominal inner diameter and type. That gives a short identification code for ordering, records and specification control.

Package marking shall include the designation, an identifying number such as a lot or batch number, the number of cylinders in the package, the manufacturer name or symbol, and the date of manufacture. This supports traceability and stock control.

What terms does ISO 13926-1:2026 define?

ISO 13926-1:2026 defines the key roles and parts used in cartridge systems.

• cartridge - the container for the medicinal product, closed by a seal at one end and a plunger stopper at the other.
• customer - the business entity that purchases cartridges and carries out further processing or filling when needed.
• manufacturer - the business entity responsible for making the cartridges for the customer.
• plunger stopper - the component that seals one end of the cartridge and moves to displace or accommodate the medicinal product.
• seal - the end component, made from a disc, septum or elastomeric closure with an aluminium cap, that closes the access end of the cartridge.

Who uses ISO 13926-1:2026?

ISO 13926-1:2026 is used by glass-cylinder manufacturers, cartridge suppliers, and businesses that purchase and fill cartridges. It also supports quality managers, product engineers and buyers who need to check dimensions, material quality, hydrolytic resistance and labelling.

It is also relevant to teams validating compatibility between the glass cylinder, plunger stopper and seal under ISO 11608-3. In practice, that means it helps with design review, incoming inspection, supplier qualification and product release decisions.

What changed in ISO 13926-1:2026 from the previous edition?

ISO 13926-1:2026 is the fifth edition and cancels and replaces ISO 13926-1:2018. The foreword states that it is technically revised.

The listed changes are:

• the title and scope were broadened to needle-based injection system general application
• the terms and definitions were updated
• Table 1 was updated for dimensions and for the new designation format using nominal volume and inner diameter
• the d1, d2 and d3 dimensions in Table 1 were changed from informative to normative
• the designation was updated to match Table 1
• Figure 2 and Table 2 were added for cartridges with vial flange configuration

Which standards are used with ISO 13926-1:2026?

ISO 13926-1:2026 refers to several standards that support testing, compatibility and related component design.

• ISO 720 - gives the hydrolytic resistance test for glass grains and the related classification
• ISO 4802-1 - gives one method for hydrolytic resistance testing of internal glass surfaces by titration
• ISO 4802-2 - gives another hydrolytic resistance method using flame spectrometry
• ISO 8362-1 - supports the vial flange configuration shown for one cylinder design
• ISO 8536-2 - is named for closures for infusion bottles, relevant to related closure components
• ISO 11608-3 - provides the verification basis for the cartridge system, including containers and integrated fluid paths
• ISO/DIS 13926-2:- - covers plunger stoppers for pen-injectors for medical use
• ISO 13926-3 - covers seals for pen-injectors for medical use

What does the ISO 13926-1:2026 document contain?

ISO 13926-1:2026 contains dimensional drawings, dimensional tables and worked designation guidance for glass cylinders used in cartridge-type NIS. It also includes material, performance and labelling requirements that are used for specification writing, supplier checks and compatibility validation.

The document’s figures and tables distinguish cartridge flange and vial flange configurations and show the market-known dimension sets. It also includes a designation example and package marking rules so users can identify the cylinder type consistently in records and on packs.

International
Standard
ISO 13926-1
Fifth edition
Cartridge systems —
2026-08
Part 1:
Glass cylinders for cartridge-type
needle-based injection systems
(NIS) for medical use
Systèmes à cartouche —
Partie 1: Flacons en verre pour systèmes d'injection à aiguille
(NIS) de type cartouche à usage médical
Reference number
© 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
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Dimensions . 2
5 Requirements . 8
5.1 Material .8
5.2 Performance .8
5.2.1 Sealing surface .8
5.2.2 Hydrolytic resistance .8
5.2.3 Annealing quality .8
6 Designation . 8
7 Labelling . 9
Bibliography .10

iii
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
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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 76, Transfusion, infusion and injection, and
blood processing equipment for medical and pharmaceutical use.
This fifth edition cancels and replaces the fourth edition (ISO 13926-1:2018), which has been technically
revised.
The main changes are as follows:
— changing the title extending glass cylinders application to needle-based injection system general
application;
— changing the scope extending glass cylinders application to needle-based injection system general
application;
— updating the terms and definitions;
— updating Table 1 for dimension and introduction of designation using nominal volume (ml)/inner
diameter (mm);
— changing the dimensions d , d and d in Table 1 from informative to normative;
1 2 3
— updating designation according to Table 1;
— adding Figure 2 and Table 2 for cartridges with vial flange configuration.
A list of all parts in the ISO 13926 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.

iv
Introduction
Primary packaging components made of glass materials are an integral part of medicinal products and
thus, the principles of current Good Manufacturing Practices (cGMP) apply to the manufacturing of these
components.
[6],[7]
Principles of cGMP are described in, for example, ISO 15378 or GMP Guidelines .

v
International Standard ISO 13926-1:2026(en)
Cartridge systems —
Part 1:
Glass cylinders for cartridge-type needle-based injection
systems (NIS) for medical use
1 Scope
This document specifies the material, performance requirements and labelling, and gives recommendations
for shape and dimensions of glass cylinders used in cartridge-type needle-based injection systems (NIS)
for medical use, according to ISO 11608-3. This document applies to the glass cylinders as supplied by the
manufacturer.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 720, Glass — Hydrolytic resistance of glass grains at 121 °C — Method of test and classification
ISO 4802-1, Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1:
Determination by titration method and classification
ISO 4802-2, Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2:
Determination by flame spectrometry and classification
ISO 8362-1, Injection containers and accessories — Part 1: Injection vials made of glass tubing
ISO 8536-2, Infusion equi
...