ISO 11040-4:2015

Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

Publication date: Apr 2, 2015

95.99 Withdrawal of Standard Jun 3, 2024

General information

Current stage: 95.99 Effective date: Jun 3, 2024

Originator: ISO

Owner: ISO/TC 76

Type: International Standard

ICS: 11.040.25

Languages: English French

Buying

Status: Withdrawn

PDF - ALL 7,350

Paper - ALL 7,350

CD - ALL 7,350

Language

Language in which you want to receive the document.

Scope

ISO 11040-4:2015 applies to

tubing-glass barrels (single-chamber design) for injection preparations, and
sterilized subassembled syringes ready for filling.

It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.
ISO 11040-4:2015 also specifies those components that are part of the sterilized subassembled syringe ready for filling.
Glass barrels and sterilized subassembled syringes ready for filling in accordance with ISO 11040-4:2015 are intended for single use only.
Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040‑4:2015.