Norm

NEN-EN-ISO 15195:2000 Ontw. en

Clinical laboratory medicine - Requirements for reference measurement laboratories

  • Deze norm is ingetrokken sinds 05-11-2003

25,62

Over deze norm

Status Ingetrokken
Aantal pagina's 12
Commissie In vitro diagnostica
Gepubliceerd op 01-10-2000
Taal Engels
This Technical Report 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 Har monization Task Force and proposed labelling regulations from Austra lia are included for comparison. IVD medical devices for self-testing are excluded.

Details

ICS-code 11.100.99
Nederlandse titel Clinical laboratory medicine - Requirements for reference measurement laboratories
Engelse titel Clinical laboratory medicine - Requirements for reference measurement laboratories
Vervangen door
Normatieve verwijzingen
  • 768/2008/EG,

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