YY/T 0456.2-2014Reagents for hematology analyzer - Part 2: Hemolysin (English PDF)

Foreword

YY/T 0456 "hematology analyzer reagent" is divided into five parts.

--- Part 1. cleaning solution;

--- Part 2. hemolytic agent;

--- Part 3. dilution;

--- Part 4. nucleated red blood cell detection reagents;

--- Part 5. reticulocyte detection reagent. This section YY/T Section 20456 of. This section drafted in accordance with GB/T 1.1-2009 given rules.

This section instead of YY/T 0456.2-2003 "hematology analyzer reagent applications," compared with the YY/T 0456.2-2003, the main technical Surgery changes are as follows.

--- Standard name "Blood Cell Analyzer agent" to "blood analyzer reagent";

--- Range "This section applies to the principle of electrical impedance of blood cell analyzer hemolytic agent" to "This section applies to blood points Analyzer hemolytic agent ";

--- Remove the "naming and classification";

--- Appearance requirements changed to "should be a clear liquid, without precipitation, particles or floc";

--- Removal requests "external signs", "Manual" contents;

--- "Net weight" to "loading capacity", its content was changed to "shall not be less than the nominal value";

--- Delete "absorbance values" content;

--- Blank WBC count requirements "<=0.3 x 10^9/L" changed to "<=0.5 x 10^9/L";

--- PH requirements "pH hemolytic agent should not exceed the product of the nominal value ± 0.20" changed to "pH should be in the range of the nominal value ± 0.50 Inside";

--- Accuracy requirements combined original reagents and reagent alternative content, content revised to "white blood cell count. relative deviation ± 7.5% Within the scope "," hemoglobin. the relative deviation within ± 3.5% range ";

--- WBC histogram modification of WBC histogram or scatter plot, scatter plot content added on request;

--- Batch difference between the requirements of "the difference between the pH of the batch should be consistent. deltapH<=0.20" was changed to "the difference between the pH of the batch should be consistent. deltapH<=1.0".

1 Scope

YY/T 0456 provisions of this part of the blood analyzer with a hemolytic agent requirements, test methods, marking, labeling and instructions for use, package Loading, transport and storage and so on. This section applies to a blood analyzer hemolytic agent.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 191 Packaging - Pictorial signs

3 Requirements