Norm

NEN-EN 13641:2002 en

Eliminatie of reductie van risico van infectie met betrekking tot in-vitro-diagnostische reagentia

35,02 42,37 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 8
Commissie In vitro diagnostica
Gepubliceerd op 01-06-2002
Taal Engels
Specifies requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrations, control materials and kits. The standard is applicable to in vitro diagnostic reagents containing material of human origin. The standard is also applicable to in vitro diagnostic reagents containing materials obtained by biotechnology processes or materials of animal origin, in particular in view of relevant zoonoses, when the results of a risk analysis reveal that there is a risk of human infection.

Details

ICS-code 11.100
Nederlandse titel Eliminatie of reductie van risico van infectie met betrekking tot in-vitro-diagnostische reagentia
Engelse titel Elimination or reduction of risk of infection related to in vitro diagnostic reagents
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