NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 18113-1 [CURRENT] references following documents:

Document number Edition Title
DIN EN ISO 17511 2021-11 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020); German version EN ISO 17511:2021 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 20417 2022-03 Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12); German version EN ISO 20417:2021 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 EN ISO 80000-1 2023-08 Quantities and units - Part 1: General (ISO 80000-1:2022); German version EN ISO 80000-1:2022 More 
DIN EN 60359 2002-09 Electrical and electronic measurement equipment - Expression of the performance (IEC 60359:2001); German version EN 60359:2002 More 
DIN EN 62366-1 ; VDE 0750-241-1:2021-08 2021-08 Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016 + A1:2020); German version EN 62366-1:2015 + AC:2015 + A1:2020 More 
DIN EN 80416-1 2009-11 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration (IEC 80416-1:2008); German version EN 80416-1:2009 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 
DIN ISO 3534-2 2013-12 Statistics - Vocabulary and symbols - Part 2: Applied statistics (ISO 3534-2:2006); Text in German and English More