NF EN ISO 18113-4

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.

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Main informations

Collections

National standards and national normative documents

Publication date

March 2010

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 - 11/03/2010

International kinship

ISO 18113-4:2009

European kinship

EN ISO 18113-4:2009
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 376
June 2002
Standard Cancelled
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing

Le présent document spécifie les exigences relatives aux informations fournies par le fabricant avec les réactifs de diagnostic in vitro pour auto-test.

Standard replaced by (1)
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

<p>ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of <i>in vitro</i> diagnostic (IVD) reagents for self-testing.</p> <p>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.</p> <p>ISO 18113-4:2009 can also be applied to accessories, where appropriate.</p> <p>ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.</p>

Table of contents
View the extract
  • 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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