Esileht»E-pood»EVS-EN 13641:2002

EVS-EN 13641:2002

Alusta uut otsingut

Osta standard

Staatus: Kehtiv

Hind: 6,47 EUR

Sirvi standardit

Tervikteksti sirvimine

Hind: 2,00 EUR

Lisa monitooringusse

In vitro diagnostiliste reaktiividega seotud infektsiooniriski kõrvaldamine või vähendamine

This European Standard 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, calibrators, control materials and kits, hereinafter called IVD reagents. 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.

Anna tagasisidet selle standardi sisu kohta