NF EN ISO 11608-5

NF EN ISO 11608-5

December 2012
Standard Cancelled

Needle-based injection systems for medical use - Requirements and test methods - Part 5 : automated functions

ISO 11608-5:2012 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans.

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Main informations

Collections

National standards and national normative documents

Publication date

December 2012

Number of pages

25 p.

Reference

NF EN ISO 11608-5

ICS Codes

11.040.25   Syringes, needles and catheters

Classification index

S93-020-5

Print number

1 - 28/11/2012

International kinship

ISO 11608-5:2012

European kinship

EN ISO 11608-5:2012
Sumary
Needle-based injection systems for medical use - Requirements and test methods - Part 5 : automated functions

ISO 11608-5:2012 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans.

Standard replaced by (1)
NF EN ISO 11608-5
March 2023
Standard Current
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Exigences
    3
  • 4.1 Exigences générales
    3
  • 4.2 Préparation
    4
  • 4.3 Injection
    5
  • 4.4 Exigences en matière d'analyse des risques
    8
  • 5 Méthodes d'essai
    8
  • 5.1 Généralités
    8
  • 5.2 Exigences de spécification de dose
    12
  • 5.3 Incertitude des mesures et conformité aux spécifications
    12
  • 6 Rapport d'essai
    12
  • 7 Informations à fournir par le fabricant
    12
  • Annexe A (informative) Justificatif
    13
  • Bibliographie
    15
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