HRN EN 13640:2008
Ispitivanje postojanosti in vitro dijagnostičkih reagensa (EN 13640:2002)
| Oznaka: | HRN EN 13640:2008 |
| Naslov (HR): | Ispitivanje postojanosti in vitro dijagnostičkih reagensa (EN 13640:2002) |
| Naslov (EN): | Stability testing of in vitro diagnostic reagents (EN 13640:2002) |
| Područje primjene (EN): | This standard is applicable to the stability testing of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. It specifies general requirements for stability testing and gives specific requirements for real-time testing and accelerated testing when generating stability data in the - determination of IVD reagent shelf-life including transport stability; - determination of stability of the IVD reagent in use after the first opening of the primary container (e. g. on-board stability); - monitoring of stability of IVD reagents already placed on the market; - verification of stability after IVD reagent modifications that may affect stability. This standard does not apply to instruments, apparatus, equipment, systems, or specimen receptacles. |
| Izdanje: | 1 |
| ICS: | 11.100 Laboratorijska medicina |
| Tehnički odbor/pododbor: | TO 555, Medicinski proizvodi |
| Oznaka faze: | 95.99 - povlačenje HRN |
| Glasilo (rasprava): | HZN Glasilo 5/2008 () |
| Glasilo (objava): | HZN Glasilo 6/2008 () |
| Glasilo (povlačenje): | HZN e-Glasilo 6/2016 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 25,00 € | Jezik: en | Cjenovni razred: C | Broj stranica: 11 |
| Izvornik: | EN 13640:2002 |
| Zamjenjena s: | HRN EN ISO 23640:2012 |
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