T/CAQI 366-2024
Clinical testing quantitative project method confirmation (English Version)

Standard No.: T/CAQI 366-2024
Language: Chinese, Available in English version
Release Date: 2024
Published By: Group Standards of the People's Republic of China
Latest: T/CAQI 366-2024

Scope: Preface 1 Scope 2 Normative references 3 Terms and definitions 4 Precision 5 Correctness 6 Measurement uncertainty 7 Analytical specificity 8 Blank limit 9 Detection limit 10 Quantitation limit 11 Measurement interval 12 Reference interval 13 Ethics and information security appendix A (Normative) Subject Sample Questionnaire References

T/CAQI 366-2024 history

2024 T/CAQI 366-2024 Clinical testing quantitative project method confirmation

Topics on standards and specifications

Detection method and method confirmation Which test methods are not sure Detection limit plan in test method validation Detection method validation and method validation Project re-do clinical Clinical Trial Project Review, confirmation and validation of test methods clinical confirmation

Standard and Specification

CNAS-GL037-2019 Guidelines for performance verification of quantitative assay procedures in clinical chemistry EN 62563-1:2010/A1:2016 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods EN 62563-1:2010 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods GSO IEC 62563-1:2013 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods IEC 62563-1:2009 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods BS EN 62563-1:2010 Medical electrical equipment - Medical image display systems - Evaluation methods IEC 62563-1:2016 Medical electrical equipment - Medical image display systems - Part1: Evaluation methods CONSOLIDATED EDITION CLSI C28-A3c-2008 Defining, Establishing, and Verifying Reference Intervals in the Clinical laboratory KS C 1221-2014 Polygraphs for clinical use CNAS-TRL-011-2020 Guidelines for Validation and Validation of Chemical Analysis Methods for Light Industrial Products

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