Norm

NEN-EN-ISO 18113-1:2007 Ontw. en

Klinische laboratoriumbeproeving en in-vitro-diagnostische medische systemen - Informatie te verstrekken door de fabrikant (merking) - Deel 1: Termen, definities en algemene eisen

  • Deze norm is ingetrokken sinds 11-01-2010

38,91

Over deze norm

Status Ingetrokken
Aantal pagina's 38
Commissie In vitro diagnostica
Gepubliceerd op 01-01-2007
Taal Engels
This International Standard specifies requirements for information supplied by the manufacturer of IVD medical devices. It consists of five parts as follows: Part 1 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. Part 2 specifies the requirements for labels and instructions for use supplied with IVD reagents, calibrators and control materials for professional use. Part 3 specifies the requirements for instructions for use supplied with IVD instruments for professional use. Part 4 specifies the requirements for labels and instructions for use supplied with IVD reagents, calibrators and control materials for self-testing. Part 5 specifies the requirements for instructions for use supplied wit h IVD instruments for self-testing.

Details

ICS-code 11.100.10
Nederlandse titel Klinische laboratoriumbeproeving en in-vitro-diagnostische medische systemen - Informatie te verstrekken door de fabrikant (merking) - Deel 1: Termen, definities en algemene eisen
Engelse titel Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
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Normatieve verwijzingen
  • 2007/47/EG,

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