Norm

NEN-EN-ISO 18113-4:2011 en

In-vitro-diagnostische medische systemen - Informatie te verstrekken door de fabrikant (labelling) - Deel 4: In-vitro-diagnostische reagentia voor het zelf-testen

52,53

Over deze norm

Status Definitief
Aantal pagina's 10
Commissie In vitro diagnostica
Gepubliceerd op 01-11-2011
Taal Engels
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to: a) IVD instruments or equipment, b) IVD reagents for professional use.

Details

ICS-code 11.100.10
Nederlandse titel In-vitro-diagnostische medische systemen - Informatie te verstrekken door de fabrikant (labelling) - Deel 4: In-vitro-diagnostische reagentia voor het zelf-testen
Engelse titel In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
Vervangt
Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica

Winkelwagen

Subtotaal:

Ga naar winkelwagen