NF ISO 11040-4

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 totubing-glass barrels (single-chamber design) for injection preparations, andsterilized 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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Main informations

Collections

National standards and national normative documents

Publication date

June 2015

Number of pages

62 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 11040-4:2015
Sumary
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.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Corps de la seringue
  • 6 Seringues pré-assemblées stérilisées préremplissables
  • 7 Emballage
  • 8 Étiquetage
  • Annexe A Exemples de types de seringues pré-assemblées stérilisées préremplissables
  • Annexe B Conceptions d'embouts
  • 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 destinée à l'évaluation de la lubrification des seringues
  • Annexe F Essai de pénétration de l'aiguille
  • Annexe G Méthodes d'essai des systèmes de fermeture
  • Annexe H Essai d'étanchéité avec solution colorante
  • Bibliographie
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