NF EN ISO 11608-3

NF EN ISO 11608-3

December 2012
Standard Cancelled

Needle-based injection systems for medical use - Requirements and test methods - Part 3 : finished containers

This part of ISO 11608 specifies the functional and design considerations for containers to be used withneedle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It is applicable to single andmulti-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the enduserintegrated in the NIS or assembled with the NIS at the time of use.This part of ISO 11608 includes specifications and test methods to describe and evaluate cartridges for usein NIS with pen needles (as defined in ISO 11608-2) and outlines design considerations for other potentialcontainers, including syringes to be used with a NIS.This part of ISO 11608 is not applicable to cartridges intended for dental use.Syringes and needles that are sold separately and not intended for use in a NIS are outside the scope of thispart of ISO 11608.NOTE See ISO 7864 (needles), ISO 8537 (insulin syringes) and ISO 7886-1 (manual syringes).

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

December 2012

Number of pages

18 p.

Reference

NF EN ISO 11608-3

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-020-3

Print number

1 - 28/11/2012

International kinship

ISO 11608-3:2012

European kinship

EN ISO 11608-3:2012
Sumary
Needle-based injection systems for medical use - Requirements and test methods - Part 3 : finished containers

This part of ISO 11608 specifies the functional and design considerations for containers to be used with

needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It is applicable to single and

multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the enduser

integrated in the NIS or assembled with the NIS at the time of use.

This part of ISO 11608 includes specifications and test methods to describe and evaluate cartridges for use

in NIS with pen needles (as defined in ISO 11608-2) and outlines design considerations for other potential

containers, including syringes to be used with a NIS.

This part of ISO 11608 is not applicable to cartridges intended for dental use.

Syringes and needles that are sold separately and not intended for use in a NIS are outside the scope of this

part of ISO 11608.

NOTE See ISO 7864 (needles), ISO 8537 (insulin syringes) and ISO 7886-1 (manual syringes).

Replaced standards (1)
NF EN ISO 11608-3
July 2001
Standard Cancelled
Pen-injectors for medical use - Part 3 : finished cartridges - Requirements and test methods

La présente partie de l'ISO 11608 spécifie les performances et les méthodes d'essai relatives aux cartouches préremplies multidoses à chambre simple servant d'emballages primaires dans les stylos-injecteurs conformes aux spécifications de l'ISO 11608. Elle spécifie la conception et les dimensions relatives aux cartouches de type A. La présente partie de l'ISO 11608 ne s'applique pas aux cartouches multichambres, les cartouches que l'utilisateur remplit lui-même ni les cartouches pour usage dentaire.

Standard replaced by (1)
NF EN ISO 11608-3
May 2022
Standard Current
Needle-based injection systems for medical use - Requirements and test methods - Part 3 : containers and integrated fluid paths

This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1. It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture. This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022). This document is not applicable to the following products: —    sterile hypodermic needles; —    sterile hypodermic syringes; —    sterile single-use syringes, with or without needle, for insulin; —    containers that can be refilled multiple times; —    containers intended for dental use; —    catheters or infusion sets that are attached or assembled separately by the user.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Exigences
    3
  • 4.1 Généralités
    3
  • 4.2 Absence de fuites
    4
  • 4.3 Force du piston
    4
  • 4.4 Dimensions
    4
  • 4.5 Excentricité
    5
  • 4.6 Visibilité du produit médical - Tous les conteneurs
    5
  • 4.7 Ménisque - Cartouche uniquement
    5
  • 4.8 Étanchéité - Tous les conteneurs
    5
  • 4.9 Particules (fragmentation)
    6
  • 4.10 Matériaux du conteneur
    6
  • 4.11 Capsule - Cartouche uniquement
    6
  • 4.12 Piston et disque - Cartouche uniquement
    6
  • 4.13 Particules - Tous les conteneurs
    6
  • 4.14 Précision de dosage - Tous les conteneurs
    6
  • 4.15 Volume injectable - Tous les conteneurs
    6
  • 4.16 Absence de dommages - Tous les conteneurs
    6
  • 5 Méthodes d'essai
    7
  • 5.1 Appareillage d'essai
    7
  • 5.2 Conditions d'essai
    7
  • 5.3 Liquide d'essai
    7
  • 5.4 Force du piston
    7
  • 5.5 Fuites (essai aux attributs)
    7
  • 5.6 Dimensions
    8
  • 6 Informations fournies par le fabricant
    9
  • Bibliographie
    10
ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
What is the Redline format?
The Redline + service - standards comparator allows you to easily and simply identify major changes between the current standard and its last canceled version.

At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula.
At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula

The Redlines + service is offered to you on the collection of French standards in force, in French language and in HTML and PDF format.

For an overview of the service, click on View a standard in redline format
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ