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eLibrary > BS ISO 21474-3:2024 In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Interpretation and reports >

BS ISO 21474-3:2024 In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Interpretation and reports, 2024

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Interpretation of results [Go to Page]
5.1 General
5.2 Methods for interpretation of results
5.3 Documentation on bioinformatics analysis
5.4 Monitoring of bioinformatics analysis
5.5 Genomic databases
5.6 Reference sequence databases
5.7 Variant identification and annotation
5.8 Categorization of variants
6 Reporting of test results [Go to Page]
6.1 General
6.2 Reporting elements
6.3 Test report content
6.4 Reporting detected variants
6.5 Reporting of secondary findings
6.6 Reporting method
Annex A (informative) Multiplex molecular test for cancer
Annex B (informative) Multivariable molecular tests
Annex C (informative) Chromosome microarray analysis test reports
Bibliography [Go to Page]

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