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BS ISO 21474-2:2022

BS ISO 21474-2:2022

$142.49

In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids – Validation and verification

Published By Publication Date Number of Pages
BSI 2022 24
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PDF Catalog

PDF Pages PDF Title
2 National foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 General requirements
4.1 General
4.2 Laboratory requirements
11 4.3 Reagents requirements
4.4 Apparatus and equipment
4.5 Reference and control materials
4.5.1 General
12 4.5.2 Endogenous nucleic acid
4.5.3 Nongenomic reference materials (RMs)
4.6 Calibration of the analysis
4.7 Input range
13 5 Evaluation of performance characteristics
5.1 General
5.2 Analytical specificity
5.2.1 Analytical reactivity
14 5.2.2 Limit of blank
5.2.3 Cross-reactivity
15 5.2.4 Exclusivity
5.2.5 Interfering substances and carryover
5.3 Range of reliable signal, reportable range and reference range
5.4 Limit of detection of multiplex molecular test platform (LODP)
16 5.5 Measurement precision and uncertainty
5.6 Accuracy and method comparison studies
18 Annex A (informative) Certified reference materials (CRMs)
20 Annex B (informative) Example of human genome reference materials (RMs)
23 Bibliography

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BS ISO 21474-2:2022
$142.49