YY/T 1549-2024
Calibrators for biochemical analyzers (English Version)

Standard No.
YY/T 1549-2024
Language
Chinese, Available in English version
Release Date
2024
Published By
Professional Standard - Medicine
Latest
YY/T 1549-2024
Replace
YY/T 1549-2017
 
Scope
This document specifies the requirements, labels, instructions for use, packaging, transportation and storage of calibrators for biochemical analyzers, and describes the corresponding test methods. This document is applicable to calibrators used on fully automatic biochemical analyzers and semi-automatic biochemical analyzers for analysis of clinical testing items. This document does not apply to calibrators for electrolyte modules of biochemical analyzers.

YY/T 1549-2024 history

Topics on standards and specifications

The calibration methods of biochemical analyzers are divided into Biochemical instrument Biochemical instrument+ Biochemical instrument Portable Biochemical Analyzer Biological automatic analyzer Biochemical Analyzer Biochemical Analyzer Four-way UV analyzer calibration Three-purpose UV analyzer calibration Grain Quality Analyzer Calibration Zhongyuan biochemical analyzer exc800 biochemical analyzer

Standard and Specification

GB/T 21415-2008 In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of values assigned to calibrators and control materials YY/T 0638-2008 In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials WS/T 356-2011 Guideline for evaluation of matrix effects and commutability YY/T 1789.6-2023 In vitro diagnostic testing system performance evaluation methods Part 6: Precision, diagnostic sensitivity and specificity of qualitative reagents YY/T 1789.1-2021 Methods for performance evaluation of in vitro diagnostic test systems Part 1: Precision YY/T 1789.3-2022 In vitro diagnostic testing system performance evaluation methods Part 3: Detection limit and quantitation limit YY/T 1789.4-2022 In vitro diagnostic testing system performance evaluation methods Part 4: Linear intervals and reportable intervals YY/T 1789.2-2021 Methods for performance evaluation of in vitro diagnostic test systems Part 2: Accuracy GB/T 19703-2020 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation GB/T 19702-2021 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for content and presentation of reference measurement procedures YY/T 1652-2019 General technical requirements for quality control materials for in vitro diagnostic reagents


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