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
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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.
To find similar documents by classification:
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