ISO/FDIS 11040-4
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
06-03-2024
English, French
02-29-2024
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
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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