NBN EN ISO 19001:2013

In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)

ACTIVE

About this standard

Languages
English and French
Type
NBN
Standards committee
CEN/TC 140
Status
ACTIVE
Publication date
21 June 2013
ICS Code
11.040.55 (Diagnostic equipment)
11.100.10 (In vitro diagnostic test systems)
Withdrawn Date
Price
€ 89,00

About this training

Summary

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.