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

ISO 19001:2013

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

This international standard 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.

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Publication Details

Date of Publication: March 1, 2013

Order Code PDF: ISO19001E

Order Code Print: print not available

Edition: Second

Pages: 14

ISO 19001:2013 Additional Details

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