Norm

NEN-EN-ISO 18113-3:2011 en

In-vitro-diagnostische medische systemen - Informatie te verstrekken door de fabrikant (labelling) - Deel 3: In-vitro-diagnostische instrumenten voor professioneel gebruik

52,53

Over deze norm

Status Definitief
Aantal pagina's 9
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 instruments for professional use. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 does not apply to: a) instructions for instrument servicing or repair, b) IVD reagents, including calibrators and control materials for use in control of the reagent, c) IVD instruments for self-testing.

Details

ICS-code 11.100.10
Nederlandse titel In-vitro-diagnostische medische systemen - Informatie te verstrekken door de fabrikant (labelling) - Deel 3: In-vitro-diagnostische instrumenten voor professioneel gebruik
Engelse titel In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
Vervangt
Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica

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