ISO 19001:2013 Preview

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

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
  • Edition : 2
    Number of pages : 14
  • :
    ISO/TC 212
    Clinical laboratory testing and in vitro diagnostic test systems
  • 11.040.55
    Diagnostic equipment
    11.100.10
    In vitro diagnostic test systems

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