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

This document specifies requirements and test methods for automated functions in needle-based injection systems with automated functions (NIS-AUTO). General requirements are provided for all automated functions. In addition, specific requirements are provided for the following automated functions: a) medicinal product preparation (e.g. reconstitution); b) needle preparation; c) needle hiding; d) priming; e) dose setting; f) needle insertion; g) injection depth control; h) injection of the medicinal product; i) recording of device functions; NOTE  This document does not cover remote communication from the NIS-AUTO (pertains to wired and wireless communication transfer from the NIS auto). j) disabling the NIS-AUTO; k) needle retraction; l) needle shielding; m) needle removal. All references to "function" in this document are by definition construed as automated functions (see 3.2). This document does not apply to functions that are performed manually 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 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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