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 18113-1 | 2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011 More |
| DIN EN ISO 18113-4 | 2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009); German version EN ISO 18113-4:2011 More |
| DIN EN ISO 18113-5 | 2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011 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 |
