ISO 19001:2013Published

In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

Dispositifs médicaux de diagnostic in vitro — Informations fournies par le fabricant avec les réactifs de coloration de diagnostic in vitro utilisés en biologie

Abstract / scope

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.

Life cycle

Replaces

ISO 19001:2002WithdrawnIn vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biologyInternational Standard · Published 15 Nov 2002 · ISO/TC 212