ISO 13926-1:2026

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
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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
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bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
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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
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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
...