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  CN  /  TUANTI
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

Definitions of Method Validation and Method Validation About Method Validation and Method Validation 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 CLSI C28-A3-2010 Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition 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 SFS-EN 62563-1:2010 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods LST EN 62563-1:2010 Medical electrical equipment - Medical image display systems -- Part 1: Evaluation methods (IEC 62563-1:2009 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 UNE-EN 62563-1:2010 Medical electrical equipment - Medical image display systems -- Part 1: Evaluation methods (Endorsed by AENOR in June of 2010 BS EN 62563-1:2010 Medical electrical equipment - Medical image display systems - Evaluation methods


Copyright ©2026 All Rights Reserved
Update: Tue, 14 Apr 2026 05:29:34 +0000