In vitro diagnostic medical devices. Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples Ingestion-build-58863 ISO 3746[7] and ISO 9614

ISO 3746[7] and ISO 9614 (all parts)[14]

The additional aerospace requirements are shown in bold

It is advisable to check these samples using large sampling procedure to prevent cross contamination of the glass fibre during the migration procedure

The effect of the thermal barrier material on the dimensional tolerances is covered by BS EN 12020-2 although the actual thermal barrier material itself is not (see BS EN 14024)

In vitro diagnostic medical devices. Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples Ingestion-build-58863 ISO 3746[7] and ISO 9614What is ISO 21151 about? ISO 21151 discusses the metrological traceability of values assigned to calibrators and human samples for In vitro diagnostic medical devices (IVDMD). ISO 21151 outlines requirements for a protocol implemented by an international body to achieve equivalent results among two or more IVD MDs for the same measurand for cases where there are no reference measurement procedures. And not fit for purpose certified reference materials