Numéro de référence
ISO/TR 18112:2006
Rapport technique
ISO/TR 18112:2006
Essais cliniques de laboratoire et systèmes d'essai de diagnostic in vitro — Dispositifs de diagnostic médical in vitro à usage professionnel — Résumé des exigences de régulation pour les informations fournies par le fabricant
Edition 1
2006-01
Annulée
ISO/TR 18112:2006
38590
Annulée (Edition 1, 2006)

Résumé

ISO/TR 18112:2006 summarizes regulatory requirements and associated guidance for information supplied by the manufacturer with IVD medical devices intended for professional use.

Information supplied by the manufacturer includes labels on the outer and immediate container as well as instructions for use.

Current labelling regulations and regulatory guidance from Canada, the European Union, Japan and the United States are included.

Labelling guidance from the Global Harmonization Task Force and proposed labelling regulations from Australia are included for comparison.

IVD medical devices for self-testing are excluded.

Informations générales

  •  : Annulée
     : 2006-01
    : Annulation de la Norme internationale [95.99]
  •  : 1
  • ISO/TC 212
    11.100.10 
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