NF EN 375

NF EN 375

April 2001
Standard Cancelled

Information supplied by the manufacturer with in vitro diagnostic reagents for professional use

Le présent document spécifie les exigences relatives aux informations fournies par le fabricant de réactifs de diagnostic in vitro incluant les supports de réaction, les calibrateurs, les matériaux de contrôle et les trousses pour usage professionnel.

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Main informations

Collections

National standards and national normative documents

Publication date

April 2001

Number of pages

17 p.

Reference

NF EN 375

ICS Codes

11.100.10   In vitro diagnostic test systems

Classification index

S92-010

Print number

1 - 22/10/2003

European kinship

EN 375:2001
Sumary
Information supplied by the manufacturer with in vitro diagnostic reagents for professional use

Le présent document spécifie les exigences relatives aux informations fournies par le fabricant de réactifs de diagnostic in vitro incluant les supports de réaction, les calibrateurs, les matériaux de contrôle et les trousses pour usage professionnel.
Replaced standards (1)
NF EN 375
October 1992
Standard Cancelled
In vitro diagnostic systems. Requirements for labelling of in vitro diagnostic reagents for professional use.

La présente norme européenne fait partie d'une série de normes sur les systèmes d'analyses médicales in vitro en préparation au Comité Européen de Normalisation (CEN). Elle spécifie les exigences applicables à l'étiquetage des réactifs pour le diagnostic in vitro à usage professionnel.

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
    3
  • 1 Domaine d'application
    4
  • 2 Références normatives
    4
  • 3 Termes et définitions
    4
  • 4 Exigences relatives aux étiquettes
    6
  • 4.1 Emballage externe
    6
  • 4.2 Contenant primaire
    8
  • 5 Exigences relatives aux instructions d'utilisation
    9
  • Annexe ZA (informative) Relation entre le présent document et les Directives CE
    13
  • Bibliographie
    15
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