NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 15197 [CURRENT] references following documents:

Document number Edition Title
EN 13612 2002-03 Performance evaluation of in vitro diagnostic medical devices More 
IEC 60068-2-64 2008-04 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broad-band random and guidance More 
IEC 61010-1 2010-06 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements More 
ISO 23640 2011-12 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents More 
DIN EN ISO 15194 2009-10 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009); German version EN ISO 15194:2009 More 
DIN EN ISO 18153 2003-11 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003); German version EN ISO 18153:2003 More 
DIN EN ISO 23640 2015-12 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015 More 
DIN ISO 3534-1 2009-10 Statistics - Vocabulary and symbols - Part 1: General statistical terms and terms used in probability (ISO 3534-1:2006); Text in German and English More 
ISO/IEC Guide 99 2007-12 International vocabulary of metrology - Basic and general concepts and associated terms (VIM) More