EN
SR EN ISO 19001:2013
Dispozitive medicale de diagnostic in vitro. Informaţii furnizate de producător cu reactivi de colorare pentru diagnostic in vitro utilizaţi în biologie
ISO 19001:2013 specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in histology and cytology including bacteriology, haematology, histochemistry, as performed in medical laboratories, both routine and research bacteriology. The requirements for information supplied by the manufacturer specified in ISO 19001:2013 are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.
Status :
In vigoare
Data aprobării : 30.08.2013
Număr de pagini : 26
ICS : 11.040.55 Echipament pentru diagnosticare,11.100.10 Sisteme pentru încercari de diagnostic in vitro
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN 12376:2003