ISO 11040-4:2024

ISO 11040-4:2024

June 2024
International standard Current

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

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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Main informations

Collections

International ISO standards

Publication date

June 2024

Number of pages

57 p.

Reference

ISO 11040-4:2024

ICS Codes

11.040.25   Syringes, needles and catheters

Print number

1
Sumary
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

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.

Replaced standards (1)
ISO 11040-4:2015
April 2015
International standard Cancelled
Prefilled syringes - Part 4 : glass barrels for injectables and sterilized subassembled syringes ready for filling

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.

Standard replaced by (1)
ISO 11040-4:2015
April 2015
International standard Cancelled
Prefilled syringes - Part 4 : glass barrels for injectables and sterilized subassembled syringes ready for filling

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.

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