YY/T 0456.1-2014Reagents for hematology analyzer - Part 1: Rinse (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 10456 of. This section drafted in accordance with GB/T 1.1-2009 given rules.

This section instead of YY/T 0456.1-2003 "hematology analyzer reagent applications," compared with the YY/T 0456.1-2003, the main technical Surgery changes are as follows.

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

--- Remove the "Classification and Nomenclature";

--- Appearance requirements "should be transparent liquid cleaning solution, without precipitation, floc particles or" to "should be a clear liquid, without Shen Lakes, particles or floc ";

--- Delete requirements "external signs" content;

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

--- PH request to modify the content of "pH should be in the range of ± 0.30 nominal value";

--- Blank WBC count requirements "<=0.3 x 10^9/L" changed to "<=0.5 x 10^9/L", red blood cell count "<=0.10 x 10^12/L "changed to" <=0.05 x 10^12/L ", platelet count" <=20 x 10^9/L "changed to" <=10 x 10^9/L ", adds Hemoglobin "<=2g/L" requirement;

--- Remove the cleaning rate;

--- Batch difference between claims "deltapH<=0.50" changed to "deltapH<=0.60".

1 Scope

YY/T 0456 provisions of this part of the blood analyzer cleaning fluid requirements, test methods, marking, labeling and instructions for use, package Loading, transport and storage and so on.

This section applies to a blood analyzer with a cleaning fluid.

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