Norm

NPR-ISO/TR 18112:2006 en

Klinische laboratoriumbeproeving en In vitro diagnostische beproevingssystemen - In vitro diagnostische medische hulpmiddelen voor professioneel gebruik - Samenvatting van eisen die gesteld worden aan de door de fabrikant te verstrekken informatie

179,33

Over deze norm

Status Definitief
Aantal pagina's 120
Commissie In vitro diagnostica
Gepubliceerd op 01-02-2006
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 Harmonization Task Force and proposed labelling regulations from Australia are included for comparison. IVD medical devices for self-testing are excluded.

Details

ICS-code 11.100.10
Nederlandse titel Klinische laboratoriumbeproeving en In vitro diagnostische beproevingssystemen - In vitro diagnostische medische hulpmiddelen voor professioneel gebruik - Samenvatting van eisen die gesteld worden aan de door de fabrikant te verstrekken informatie
Engelse titel Clinical laboratory testing and in vitro diagnostic test systems - In vitro diagnostic medical devices for professional use - Summary of regulatory requirements for information supplied by the manufacturer

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