NF EN ISO 18113-5

NF EN ISO 18113-5

March 2010
Standard Cancelled

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.ISO 18113-5:2009 can also be applied to accessories.

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Main informations

Collections

National standards and national normative documents

Publication date

March 2010

Number of pages

18 p.

Reference

NF EN ISO 18113-5

ICS Codes

11.100.10   In vitro diagnostic test systems

Classification index

S92-010-5

Print number

1 - 11/03/2010

International kinship

ISO 18113-5:2009

European kinship

EN ISO 18113-5:2009
Sumary
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.

ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.

ISO 18113-5:2009 can also be applied to accessories.

Replaced standards (1)
NF EN 592
June 2002
Standard Cancelled
Instructions for use for in vitro diagnostic instruments for self-testing

Le présent document spécifie le contenu des notices d'utilisation des instruments de diagnostic in vitro pour auto-test.

Standard replaced by (1)
NF EN ISO 18113-5
May 2012
Standard Current
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing. ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. ISO 18113-5:2009 can also be applied to accessories.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Généralités
    2
  • 5 Étiquettes et étiquetage
    2
  • 5.1 Généralités
    2
  • 5.2 Identification de l'instrument de DIV
    2
  • 6 Éléments de la notice d'utilisation
    3
  • 7 Contenu de la notice d'utilisation
    3
  • 7.1 Fabricant
    3
  • 7.2 Identification de l'instrument de DIV
    3
  • 7.3 Utilisation prévue
    4
  • 7.4 Stockage et manipulation
    4
  • 7.5 Avertissements et mesures de précaution
    4
  • 7.6 Installation de l'instrument
    4
  • 7.7 Principes de mesure
    5
  • 7.8 Performance de l'instrument de DIV
    5
  • 7.9 Limites d'utilisation
    5
  • 7.10 Préparation avant utilisation
    5
  • 7.11 Mode opératoire
    5
  • 7.12 Mode opératoire de contrôle
    6
  • 7.13 Lecture des résultats d'analyse
    6
  • 7.14 Fonctions spéciales
    6
  • 7.15 Mode opératoire d'arrét
    6
  • 7.16 Instructions relatives à la mise au rebut
    6
  • 7.17 Maintenance
    7
  • 7.18 Dépannage
    7
  • 7.19 Action de suivi
    7
  • Bibliographie
    8
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