In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Terminology and general requirements for nucleic acid quality evaluation1 Scope This document provides the terms and general requirements for the evaluation of the quality of nucleic acids as the analytes for multiplex molecular tests, which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex molecular methods used for examination using in vitro diagnostic (IVD) medical devices and laboratory developed tests (LDTs). It provides information for both

What is ISO/IEC 29101 about

1 Frequencies

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it is necessary to include normative requirements (such as target and limit values for the analysis) into a document

It varies depending on the type of structure

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7 Sampling device preparation and assembly

BS ISO/IEC 24713-3:2009 Information technology