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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) EN ISO 19001:2013

Publication date:   Apr 17, 2013

General information

60.60 Standard published   Mar 20, 2013

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.040.55   Diagnostic equipment | 11.100.10   In vitro diagnostic test systems

Buying

Published

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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

PREVIOUSLY

WITHDRAWN
EN 12376:1999

NOW

PUBLISHED
EN ISO 19001:2013
60.60 Standard published
Mar 20, 2013