ISO 15193:2009 - $138.00   BUY NOW

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures

ISO 15193:2009 Publication Description:

ISO 15193:2009 specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.

ISO 15193:2009 applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.

ISO 15193:2009 is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure.

International Classification for Standards (ICS)

ICS Classification Field ICS Field Sub-Group and Number
ICS-11-Health ICS In Vitro Diagnostic Test Systems (11.100.10)

ICS Related Standards

Cart Document Number Document Title
$103.00 ISO 13079:2011 Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method
$103.00 ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
$185.00 ISO 15197:2013 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
$68.00 ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
$103.00 ISO 16256:2012 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
$138.00 ISO 17511:2003 In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials
$275.00 ISO/TR 18112:2006 Clinical laboratory testing and in vitro diagnostic test systems - In vitro diagnostic medical devices for professional use - Summary of regulatory requirements for information supplied by the manufacturer
$185.00 ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
$68.00 ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
$68.00 ISO 18113-3:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
$68.00 ISO 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
$68.00 ISO 18113-5:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
$68.00 ISO 18153:2003 In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
$103.00 ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
$68.00 ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
$138.00 ISO 29701:2010 Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test