NF EN ISO 18113-3

NF EN ISO 18113-3

March 2010
Standard Cancelled

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 : in vitro diagnostic instruments for professional use

ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use.ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use.ISO 18113-3:2009 can also be applied to accessories, where appropriate.

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Main informations

Collections

National standards and national normative documents

Publication date

March 2010

Number of pages

19 p.

Reference

NF EN ISO 18113-3

ICS Codes

11.100.10   In vitro diagnostic test systems

Classification index

S92-010-3

Print number

1 - 11/03/2010

International kinship

ISO 18113-3:2009

European kinship

EN ISO 18113-3:2009
Sumary
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 : in vitro diagnostic instruments for professional use

ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use.

ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use.

ISO 18113-3:2009 can also be applied to accessories, where appropriate.

Replaced standards (1)
NF EN 591
May 2001
Standard Cancelled
Instructions for use for in vitro diagnostic instruments for professional use

Le présent document spécifie les exigences s'appliquant au contenu des notices d'utilisation pour les instruments de diagnostic in vitro incluant les appareils, les équipements, les calibrateurs et les matériaux de contrôle à usage professionnel.

Standard replaced by (1)
NF EN ISO 18113-3
May 2012
Standard Current
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 : in vitro diagnostic instruments for professional use

ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use. ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. ISO 18113-3:2009 can also be applied to accessories, where appropriate.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Exigences essentielles
    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 Principe de fonctionnement
    5
  • 7.8 Fonctions
    6
  • 7.9 Performance de l'instrument de DIV
    6
  • 7.10 Limites d'utilisation
    6
  • 7.11 Préparation avant utilisation
    6
  • 7.12 Mode opératoire d'execution
    6
  • 7.13 Mode opératoire de contrôle
    7
  • 7.14 Calcul des résultats d'analyse
    7
  • 7.15 Fonctions spéciales
    7
  • 7.16 Échantillons primaires d'urgence
    7
  • 7.17 Mode opératoire d'arrêt
    7
  • 7.18 Instructions relatives à la mise au rebut
    7
  • 7.19 Maintenance
    8
  • 7.20 Dépannage
    8
  • Bibliographie
    9
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