Reference number
ISO 19001:2013
© ISO 2025
International Standard
ISO 19001:2013
In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
Edition 2
2013-03
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Published (Edition 2, 2013)
This publication was last reviewed and confirmed in 2024. Therefore this version remains current.

ISO 19001:2013

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Format
CHF 98
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Abstract

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.

General information

  • Status
     : Published
    Publication date
     : 2013-03
    Stage
    : International Standard confirmed [90.93]
  • Edition
     : 2
    Number of pages
     : 14
  • Technical Committee :
    ISO/TC 212
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