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YY/T 0456.2-2014: Reagents for hematology analyzer. Part 2: Hemolysin
Status: Valid YY/T 0456.2: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0456.2-2014 | English | 169 |
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Reagents for hematology analyzer. Part 2: Hemolysin
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YY/T 0456.2-2014
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| YY/T 0456.2-2003 | English | 319 |
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Regents for hematology analyzer use-Part 2: Hemolysin
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YY/T 0456.2-2003
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PDF similar to YY/T 0456.2-2014
Basic data | Standard ID | YY/T 0456.2-2014 (YY/T0456.2-2014) | | Description (Translated English) | Reagents for hematology analyzer. Part 2: Hemolysin | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 7,767 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Older Standard (superseded by this standard) | YY/T 0456.2-2003 | | Quoted Standard | GB/T 191 | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to a blood analyzer hemolytic agent. This Standard specifies the hematology analyzer hemolytic agent requirements, test methods, marking, labeling and instructions for use, packaging, transport and storage and so on. | YY/T 0456.2-2014: Reagents for hematology analyzer. Part 2: Hemolysin---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Reagents for hematology analyzer.Part 2. Hemolysin
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0456.2-2003
Blood analyzer reagent
Part 2. hemolytic agent
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
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 × 109/L" changed to "≤0.5 × 109/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. ΔpH≤0.20" was changed to "the difference between the pH of the batch should be consistent. ΔpH≤1.0".
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This part is proposed by the China Food and Drug Administration.
This part of the National Medical clinical testing laboratory and in-vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This section is drafted. Beijing Medical Device Testing, Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Jiang Xi Tekang science and technology have
Limited, Beckman Coulter, Inc., Panyu District, Guangzhou City Science and Technology Co., Ltd. Huaxin.
The main drafters of this section. Yang Zongbing, Xuwen Juan, Zhang Zhao Park, Xiao Yan, Yin Qi Man, Zhanghao Jia.
This section was first released in 2003.
Blood analyzer reagent
Part 2. hemolytic agent
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
3.1 Appearance
It should be a clear liquid, without precipitation, particles or floc.
3.2 PACKING
It should not be less than the nominal value.
3.3 pH
The pH should be within ± 0.50 in nominal value range.
3.4 absorption peak wavelength
After hemolysis hemolytic agent, a characteristic absorption peak wavelength λmax should be within ± 10nm nominal value range.
3.5 Blank Count
Blank count shall conform to the requirements of Table 1.
Table 1 count blank
Test project requirements
White blood cell count (WBC) ≤0.5 × 109/L
Hemoglobin (HGB) ≤2g/L
3.6 accuracy
Deviation of the test results shall comply with the requirements of Table 2.
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