NF EN ISO 11608-1

NF EN ISO 11608-1

February 2015
Standard Current

Needle-based injection systems for medical use - Requirements and test methods - Part 1 : needle-based injection systems

ISO 11608-1:2014 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in ISO 11608-1:2014 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user.

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Main informations

Collections

National standards and national normative documents

Publication date

February 2015

Release date

mai 2025 par NF EN ISO 11608-1 de 2015

Number of pages

52 p.

Reference

NF EN ISO 11608-1

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-020-1

Print number

1

International kinship

ISO 11608-1:2014

European kinship

EN ISO 11608-1:2015
Sumary
Needle-based injection systems for medical use - Requirements and test methods - Part 1 : needle-based injection systems

ISO 11608-1:2014 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in ISO 11608-1:2014 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user.

Replaced standards (1)
NF EN ISO 11608-1
July 2012
Standard Cancelled
Needle-based injection systems for medical use - Requirements and test methods - Part 1 : needle-based injection systems

Le présent document spécifie les exigences et les méthodes d'essai des systèmes d'injection à aiguille (NIS) destinés à être utilisés avec des aiguilles et des conteneurs remplaçables ou non remplaçables. Les conteneurs couverts par la présente partie de l'ISO 11608 comprennent les systèmes à seringue et à cartouche à dose unique ou à doses multiples, qu'ils soient remplis par le fabricant ou par l'utilisateur final.

Table of contents
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  • Avant-propos
    v
  • Introduction
    vii
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Symboles et abréviations
    3
  • 5 Exigences
    5
  • 6 Réactifs et appareillage
    7
  • 7 Détermination de la précision de dosage
    8
  • 8 Préparation et fonctionnement des NIS
    14
  • 9 Matrice d'essai
    14
  • 10 Description des essais
    14
  • 11 Inspection
    22
  • 12 Rapport d'essai
    23
  • 13 Informations fournies par le fabricant
    24
  • Annexe A (informative) Justification des séries de doses répétitives, de la précision et des essais recommandés
    27
  • Annexe B (normative) Facteurs de limite de dispersion unilatéraux et bilatéraux, k
    31
  • Bibliographie
    42
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