ISO-19001 › In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

ISO-19001 - 2ND EDITION - CURRENT -- See the following: EN-375 EN-376
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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.

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11.040.55 (Diagnostic equipment Including medical monitoring equipment, medical thermometers and related materials)

11.100.10 (In vitro diagnostic test systems)

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Document Number

ISO 19001:2013

Revision Level

2ND EDITION

Status

Current

Publication Date

March 15, 2013

Committee Number

ISO/TC 212