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Standard
ISO 11040-4
Fourth edition
Prefilled syringes —
2024-06
Part 4:
Glass barrels for injectables and
sterilized subassembled syringes
ready for filling
Seringues préremplies —
Partie 4: Cylindres en verre pour produits injectables et seringues
pré-assemblées stérilisées préremplissables
Reference number
ISO 11040-4:2024(en) © ISO 2024
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ISO 11040-4:2024(en)
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Published in Switzerland
© ISO 2024 – All rights reserved
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ISO 11040-4:2024(en)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 4
4.1 Quality systems .4
4.2 Testing .4
4.3 Documentation .4
5 Syringe barrel . 4
5.1 Design including dimensions .4
5.1.1 Dimensions for 6 % Luer slip and 6 % Luer slip for Luer lock adapter front end
syringes .4
5.1.2 Specific dimensions for front end design for 6 % Luer slip and 6 % Luer slip for
Luer lock adapter .6
5.1.3 Dimensions for staked needle (SN) syringes .7
5.1.4 Front end design for staked needle syringe .9
5.2 Functional testing of Luer connection .10
5.3 Material .
...