NF EN ISO 18113-2

NF EN ISO 18113-2

May 2012
Standard Current

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use

ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use.ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.ISO 18113-2:2009 can also be applied to accessories.ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

May 2012

Release date

juin 2027 par NF EN ISO 18113-2 de 2012

Number of pages

20 p.

Reference

NF EN ISO 18113-2

ICS Codes

11.100.10   In vitro diagnostic test systems

Classification index

S92-010-2

Print number

1 - 13/04/2012

International kinship

ISO 18113-2:2009

European kinship

EN ISO 18113-2:2011
Sumary
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use

ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use.

ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.

ISO 18113-2:2009 can also be applied to accessories.

ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.

Replaced standards (1)
NF EN ISO 18113-2
March 2010
Standard Cancelled
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use

ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use. ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. ISO 18113-2:2009 can also be applied to accessories. ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.

Standard replaced by (1)
NF EN ISO 18113-2
March 2010
Standard Cancelled
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use

ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use. ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. ISO 18113-2:2009 can also be applied to accessories. ISO 18113-2:2009 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
  • 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
    2
  • 5.4 Utilisation prévue
    2
  • 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
    3
  • 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
    4
  • 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 Traçabilité des valeurs attribuées aux étalons et aux matériaux de contrôle de la justesse
    6
  • 7.6 Éléments
    6
  • 7.7 Équipement supplémentaire requis
    6
  • 7.8 Préparation des réactifs
    6
  • 7.9 Conservation et durée de vie après la première ouverture du récipient
    7
  • 7.10 Avertissements et mesures de précaution
    7
  • 7.11 Recueil, manipulation et conservation d'échantillon primaire
    7
  • 7.12 Procédure d'analyse
    7
  • 7.13 Procédure de contrôle
    7
  • 7.14 Calcul des résultats d'analyse
    8
  • 7.15 Interprétation des résultats
    8
  • 7.16 Caractéristiques de performances
    8
  • 7.17 Intervalles de référence biologiques
    9
  • 7.18 Limites du mode opératoire d'analyse
    9
  • 7.19 Références bibliographiques
    9
  • Bibliographie
    10
ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
What is the Redline format?
The Redline + service - standards comparator allows you to easily and simply identify major changes between the current standard and its last canceled version.

At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula.
At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula

The Redlines + service is offered to you on the collection of French standards in force, in French language and in HTML and PDF format.

For an overview of the service, click on View a standard in redline format
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ