BS ISO 21474-1:2020 In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Terminology and general requirements for nucleic acid quality evaluation
What is ISO 21474-1 about?
ISO 21474 discusses In vitro diagnostic medical devices on multiplex molecular testing for nucleic acids. ISO 21474-1 outlines provide 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.
ISO 21474-1 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 qualitative and quantitative detection of nucleic acid target sequences.