ISO 11040:2024
ISO 11040:2024 Prefilled syringes – Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
CDN $351.00
Description
This document specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.
This document also specifies components that are part of the sterilized subassembled syringe ready for filling.
This document is applicable to
–¬†¬†¬†¬† tubing-glass barrels (single-chamber design) for injection preparations, and
–¬†¬†¬†¬† sterilized subassembled syringes ready for filling.
Glass barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only.
Components to complete the subassembled syringe, such as plunger stopper and plunger rod, are outside the scope of this document.
NOTE            National or regional regulations such as Ph.Eur., USP, or JP can apply.
Edition
4
Published Date
2024-06-03
Status
PUBLISHED
Pages
53
Language
English
Format
Secure PDF
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Abstract
This document specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.
This document also specifies components that are part of the sterilized subassembled syringe ready for filling.
This document is applicable to
-     tubing-glass barrels (single-chamber design) for injection preparations, and
-     sterilized subassembled syringes ready for filling.
Glass barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only.
Components to complete the subassembled syringe, such as plunger stopper and plunger rod, are outside the scope of this document.
NOTE            National or regional regulations such as Ph.Eur., USP, or JP can apply.
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