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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

Publication date:   Mar 7, 2013

General information

90.93 Standard confirmed   Jan 17, 2024

ISO

ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems

International Standard

11.100.10   In vitro diagnostic test systems | 11.040.55   Diagnostic equipment

Buying

Published

Language in which you want to receive the document.

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WITHDRAWN
ISO 19001:2002

NOW

PUBLISHED
ISO 19001:2013
90.93 Standard confirmed
Jan 17, 2024