Norm

NEN-EN 1041:1998 en

Informatie die door de fabrikant bij medische hulpmiddelen wordt geleverd

  • Deze norm is ingetrokken sinds 21-08-2008

61,30

Over deze norm

Status Ingetrokken
Aantal pagina's 24
Commissie Medische hulpmiddelen - horizontale onderwerpen
Gepubliceerd op 01-03-1998
Taal Engels
Specifies requirements on information to be supplied by a manufacturer for different categories of medical devices, as required by the relevant EU Directives. It does not specify the language to be used for such information. It is intended to complement the specific requirements of the EU Directives on medical devices in the context of specifying means by which certain requirements can be met. If these means are followed by a manufacturer, they will provide presumption of conformity with the relevant essential requirements regarding information to be supplied.

Details

ICS-code 01.110
11.040.01
11.120.01
Nederlandse titel Informatie die door de fabrikant bij medische hulpmiddelen wordt geleverd
Engelse titel Information supplied by the manufacturer with medical devices
Vervangt
Vervangen door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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