NF ISO 11040-6

NF ISO 11040-6

July 2019
Standard Current

Prefilled syringes - Part 6 : plastic barrels for injectables and sterilized subassembled syringes ready for filling

This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for single use only. This document also specifies those components that are part of the sterilized subassembled syringe ready for filling. Polymer 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 and rod, are not specified in this document. Prefilled syringes can be produced on dedicated and specifically designed processing equipment such as inline moulding and filling. This document does not apply but can be used also for such dedicated prefilled syringes.

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Main informations

Collections

National standards and national normative documents

Publication date

July 2019

Number of pages

59 p.

Reference

NF ISO 11040-6

ICS Codes

11.040.25   Syringes, needles and catheters

Classification index

S93-006-6

Print number

1

International kinship

ISO 11040-3:2019
Sumary
Prefilled syringes - Part 6 : plastic barrels for injectables and sterilized subassembled syringes ready for filling

This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for single use only.

This document also specifies those components that are part of the sterilized subassembled syringe ready for filling.

Polymer 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 and rod, are not specified in this document.

Prefilled syringes can be produced on dedicated and specifically designed processing equipment such as inline moulding and filling. This document does not apply but can be used also for such dedicated prefilled syringes.

Replaced standards (1)
NF ISO 11040-6
August 2012
Standard Cancelled
Prefilled syringes - Part 6 : plastic barrels for injectables

Le présent document spécifie les matériaux, les dimensions et les exigences pour les corps de seringue en matière plastique (à un compartiment) pour préparations d'injection, qui sont destinés par la suite à être remplis et assemblés à l'aide d'un matériel de fabrication normalisé. Il est applicable aux seringues préremplies en matière plastique non réutilisables. Certaines seringues préremplies peuvent être préparées à l'aide d'un équipement dédié et spécialement conçu. Le présent document ne s'applique pas à ce type de seringues préremplies dédiées. Avant que l'homologation finale pour l'usage humain ne puisse être accordée, il est procédé à des essais de compatibilité sur les produits pharmaceutiques visés. Le présent document ne spécifie pas les modes opératoires pour ces essais de compatibilité.

Table of contents
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  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Dimensions et désignation
  • 6 Exigences
  • 7 Graduation
  • 8 Emballage et étiquetage
  • Annexe C (normative) Méthodes d'essai des corps de seringue
  • Annexe G (normative) Méthodes d'essai des systèmes de fermeture des seringues
  • Annexe A (informative) Exemples de types de seringues pré-assemblées stérilisées préremplissables
  • Annexe B (informative) Exemples de configurations d'embout de seringue
  • Annexe D (informative) Préparation d'échantillons pour la quantification des endotoxines et des particules
  • Annexe E (informative) Évaluation de la lubrification des seringues par méthode d'essai relative à la force de glissement
  • Annexe F (informative) Essai de pénétration de l'aiguille
  • Annexe H (informative) Essai d'étanchéité avec solution colorante
  • Annexe I (informative) Recommandations relatives aux matériaux
  • Bibliographie
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