NF EN 13532

NF EN 13532

November 2002
Standard Current

General requirements for in vitro diagnostic medical devices for self-testing

Le présent document spécifie les exigences générales relatives aux dispositifs médicaux de diagnostic in vitro pour auto-test.

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Main informations

Collections

National standards and national normative documents

Publication date

November 2002

Number of pages

10 p.

Reference

NF EN 13532

ICS Codes

11.100.10   In vitro diagnostic test systems

Classification index

S92-024

Print number

1 - 07/12/2002

European kinship

EN 13532:2002
Sumary
General requirements for in vitro diagnostic medical devices for self-testing

Le présent document spécifie les exigences générales relatives aux dispositifs médicaux de diagnostic in vitro pour auto-test.
Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Critères de conception
  • 5 Marquage et informations fournies par le fabricant
  • 6 Évaluation des performances
  • 7 Vérification par l'utilisateur
  • ZA Articles de la présente Norme européenne concernant les exigences essentielles ou d'autres dispositions des Directives UE
  • Bibliographie
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