NF EN 376

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.

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Main informations

Collections

National standards and national normative documents

Publication date

June 2002

Number of pages

16 p.

Reference

NF EN 376

ICS Codes

11.100.10   In vitro diagnostic test systems

Classification index

S92-011

Print number

1 - 07/12/2002

European kinship

EN 376:2002
Sumary
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.
Replaced standards (1)
NF EN 376
October 1992
Standard Cancelled
In vitro diagnostic systems. Requirements for labelling of in vitro diagnostic reagents for self-testing.

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 pour utilisation comme autotest.

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

<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
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  • Avant-propos
    3
  • 1
    Domaine d'application 4
  • 2
    Références normatives 4
  • 3
    Termes et définitions 4
  • 4
    Exigences relatives aux étiquettes 6
  • 5
    Exigences relatives à la notice d'utilisation 9
  • Annexe ZA (informative) Articles de la présente Norme européenne concernant les exigences essentielles ou d'autres dispositions des Directives UE
    12
  • Bibliographie
    14
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