NF ISO 11040-4

NF ISO 11040-4

June 2024
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

National standards and national normative documents

Publication date

June 2024

Number of pages

64 p.

Reference

NF ISO 11040-4

ICS Codes

11.040.25   Syringes, needles and catheters

Classification index

S93-006-4

Print number

1

International kinship

ISO 11040-4:2024
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 (2)
NF ISO 11040-4
June 2015
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.

NF ISO 11040-4/A1
June 2020
Standard Cancelled
Prefilled syringes - Part 4 : glass barrels for injectables and sterilized subassembled syringes ready for filling - Amendment 1

Le présent amendement complète la norme NF ISO 11040-4, de juin 2015, en apportant un certain nombre de modifications sur l'ensemble du corps du texte.

Standard replaced by (2)
NF ISO 11040-4
June 2015
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.

NF ISO 11040-4/A1
June 2020
Standard Cancelled
Prefilled syringes - Part 4 : glass barrels for injectables and sterilized subassembled syringes ready for filling - Amendment 1

Le présent amendement complète la norme NF ISO 11040-4, de juin 2015, en apportant un certain nombre de modifications sur l'ensemble du corps du texte.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Corps de seringue
  • 6 Seringues pré-assemblées stérilisées préremplissables
  • 7 Emballage
  • 8 Étiquetage
  • Annexe A Exemples de types de seringues pré-assemblées stérilisées préremplissables
  • Annexe B Composants supplémentaires pour une seringue prête à l'emploi préremplissable
  • Annexe C Méthodes d'essai des corps de seringue
  • Annexe D Préparation d'échantillons pour la mesure des endotoxines et des particules
  • Annexe E Méthode d'essai relative à la force de glissement
  • Annexe F Essai de pénétration de l'aiguille
  • Annexe G Méthodes d'essai pour les composants à l'extrémité de la seringue
  • Annexe H Essai d'étanchéité
  • Bibliographie
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