NF EN ISO 18113-4

NF EN ISO 18113-4

May 2012
Standard Current

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing

ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.ISO 18113-4:2009 can also be applied to accessories, where appropriate.ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.

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Main informations

Collections

National standards and national normative documents

Publication date

May 2012

Release date

juin 2027 par NF EN ISO 18113-4 de 2012

Number of pages

20 p.

Reference

NF EN ISO 18113-4

ICS Codes

11.100.10   In vitro diagnostic test systems

Classification index

S92-010-4

Print number

1 - 13/04/2012

International kinship

ISO 18113-4:2009

European kinship

EN ISO 18113-4:2011
Sumary
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing

ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.

ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.

ISO 18113-4:2009 can also be applied to accessories, where appropriate.

ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.

Replaced standards (1)
NF EN ISO 18113-4
March 2010
Standard Cancelled
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing

ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing. ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. ISO 18113-4:2009 can also be applied to accessories, where appropriate. ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.

Standard replaced by (1)
NF EN ISO 18113-4
March 2010
Standard Cancelled
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing

ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing. ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. ISO 18113-4:2009 can also be applied to accessories, where appropriate. ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Généralités
    2
  • 4.1 Exigences essentielles
    2
  • 4.2 Identification des éléments d'une trousse
    2
  • 4.3 Présentation de la notice d'utilisation
    2
  • 5 Contenu de l'étiquette de l'emballage externe
    2
  • 5.1 Fabricant
    2
  • 5.2 Identification du réactif de DIV
    2
  • 5.3 Contenu
    3
  • 5.4 Utilisation prévue
    3
  • 5.5 Utilisation dans le diagnostic in vitro
    3
  • 5.6 Conditions de stockage et de manipulation
    3
  • 5.7 Date de péremption
    3
  • 5.8 Avertissements et mesures de précaution
    4
  • 6 Contenu de l'étiquette du contenant primaire
    4
  • 6.1 Dispositions générales
    4
  • 6.2 Fabricant
    4
  • 6.3 Identification du réactif de DIV
    4
  • 6.4 Contenu
    4
  • 6.5 Utilisation dans le diagnostic in vitro
    4
  • 6.6 Conditions de stockage et de manipulation
    5
  • 6.7 Date de péremption
    5
  • 6.8 Avertissements et mesures de précaution
    5
  • 7 Contenu de la notice d'utilisation
    5
  • 7.1 Fabricant
    5
  • 7.2 Identification du réactif de DIV
    5
  • 7.3 Utilisation prévue
    5
  • 7.4 Principe de la méthode d'analyse
    6
  • 7.5 Éléments
    6
  • 7.6 Équipement supplémentaire requis
    6
  • 7.7 Préparation des réactifs
    6
  • 7.8 Conservation et durée de vie après la première ouverture du contenant
    6
  • 7.9 Avertissements et mesures de précaution
    6
  • 7.10 Recueil, manipulation et conservation d'échantillon primaire
    7
  • 7.11 Mode opératoire d'analyse
    7
  • 7.12 Mode opératoire de contrôle
    7
  • 7.13 Lecture des résultats d'analyse
    7
  • 7.14 Interprétation des résultats
    7
  • 7.15 Caractéristiques de performance
    8
  • 7.16 Intervalles de référence biologiques
    8
  • 7.17 Limites du mode opératoire d'analyse
    8
  • 7.18 Références bibliographiques
    8
  • Bibliographie
    9
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