YY/T 0701-2021Calibrator for hematology analyzer (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces YY/T 0701-2008 "Calibrators (products) for blood cell analyzers", compared with YY/T 0701-2008, except for editing The main changes in addition to the sexual modifications are as follows:

--- Modify the standard name to calibrator for blood analyzers;

---The text description in the normative reference document is written according to GB/T 1.1-2009;

--- Normative reference document changes;

--- Increase the terms and definitions "accuracy" and "correctness";

--- Modification of appearance description;

--- Modification of uniformity requirements;

--- Traceability requirements modification;

--- The accuracy of assignment requires modification;

--- remove biosecurity;

--- Stability requirements modification;

--- Modification of uniformity method;

--- Traceability method modification;

--- Assignment accuracy method modification;

--- Removal of biosecurity methods;

--- Increase accuracy requirements and methods;

--- Modification of stability testing method;

--- Logos, labels, and instruction manuals are modified as usual;

---Packaging, transportation and storage are modified as usual.

1 Scope

This standard specifies the terms and definitions, technical requirements, test methods, signs, Labels and instructions, packaging, transportation and storage.

This standard applies to calibrators for blood analyzers. This calibrator is only used for calibrating the white blood cells of a blood analyzer (also known as a blood cell analyzer).

Cell count (WBC), red blood cell count (RBC), hemoglobin determination (HGB), mean hematocrit volume (MCV)/hematocrit determination (HCT), platelet count (PLT) five parameters, so as to establish the metrological traceability of the measurement results of the blood analyzer.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 191-2008 Graphical signs of packaging, storage and transportation

GB/T 29791.2-2013 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) - Part 2. In vitro diagnostics for professional use break reagent

3 Terms and Definitions

The following terms and definitions apply to this document.