ISO 13926-1:2018

Pen systems — Part 1: Glass cylinders for pen-injectors for medical use

This document specifies the design, materials, performance and test methods, and gives recommendations for dimensions for glass cylinders used with pen-injectors for medical use. It applies to the primary containers used in direct contact with the drug.

Systèmes de stylos-injecteurs — Partie 1: Cylindres en verre pour des stylos-injecteurs à usage médical

General Information

• Status: Published
• Publication Date: 14-Oct-2018
• 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: 9060 - Close of review
• Start Date: 04-Jun-2029

Relations

• Revises: ISO 13926-1:2004 - Pen systems — Part 1: Glass cylinders for pen-injectors for medical use
• Effective Date: 18-Mar-2017

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 13926-1
Fourth edition
2018-11
Pen systems —
Part 1:
Glass cylinders for pen-injectors for
medical use
Systèmes de stylos-injecteurs —
Partie 1: Cylindres en verre pour des stylos-injecteurs à usage médical
Reference number
ISO 13926-1:2018(E)
©
ISO 2018

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ISO 13926-1:2018(E)

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ii © ISO 2018 – All rights reserved

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ISO 13926-1:2018(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Dimensions . 1
5 Requirements . 3
5.1 Material . 3
5.2 Performance . 3
5.2.1 Sealing surface . 3
5.2.2 Hydrolytic resistance . 3
5.2.3 Annealing quality . 3
6 Designation . 4
7 Package marking . 4
Bibliography . 5
© ISO 2018 – All rights reserved iii

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ISO 13926-1:2018(E)

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
...