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YY/T 0456.3-2014: Reagents for hematology analyzer. Part 3: Diluent
Status: Valid YY/T 0456.3: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0456.3-2014 | English | 169 |
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Reagents for hematology analyzer. Part 3: Diluent
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YY/T 0456.3-2014
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| YY/T 0456.3-2003 | English | 319 |
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Regents for hematology analyzer use-Part 3: Diluent
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YY/T 0456.3-2003
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PDF similar to YY/T 0456.3-2014
Basic data | Standard ID | YY/T 0456.3-2014 (YY/T0456.3-2014) | | Description (Translated English) | Reagents for hematology analyzer. Part 3: Diluent | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 7,776 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Older Standard (superseded by this standard) | YY/T 0456.3-2003 | | Quoted Standard | GB/T 191 | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30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 with dilution. This Standard specifies requirements for blood analyzer with dilution, test methods, marking, labeling and instructions for use, packaging, transport and storage and so on. | YY/T 0456.3-2014: Reagents for hematology analyzer. Part 3: Diluent---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 3. Diluent
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0456.3-2003
Blood analyzer reagent
Part 3. Diluent
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 30456 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This section instead of YY/T 0456.3-2003 "hematology analyzer reagent applications," compared with the YY/T 0456.3-2003, the main technical
Surgery changes are as follows.
--- Standard name "Blood Cell Analyzer agent" to "blood analyzer reagent";
--- "And this section applies to electrical impedance hematology analyzer with diluent" to "this part applies to dilute the blood analyzer
Dilutions ";
--- Appearance requirements changed to "should be a clear liquid, without precipitation, particles or floc";
--- Content removal requests external signs;
--- "Net weight" to "loading capacity", its content was changed to "shall not be less than the nominal value";
--- "Blank count" to "particle counter", modify its content as "≥2.5fL particle count ≤2.5 × 105/L", its square test
Modify the method for testing with a particle counter;
--- Combined accuracy requirements in relation to the original reagents and alternative reagents, the accuracy of the claim was changed to "white blood cell count relative partial
Difference is within the range of ± 7.5% relative standard deviation in the red blood cell count within the range of ± 3.0% relative standard deviation in platelet count
± 12.5% of the relative deviation of hemoglobin within the range of ± 3.5%, mean corpuscular volume/hematocrit relative
Deviation within ± 3.0% range ";
--- Delete "colonies" content;
--- Batch difference between content was revised to "the difference between the pH of the batch should be consistent. ΔpH≤0.40, conductivity difference between batches should be consistent. Δρ≤100mS/m,
Inter-assay osmolality difference should be consistent. ≤20mmol/L (mOsm/kg) ".
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 standard was proposed by the China Food and Drug Administration.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was 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 standard. 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 3. Diluent
1 Scope
YY/T 0456 provisions of this part of the blood analyzer with the requirements of diluent, test methods, marking, labeling and instructions for use, package
Loading, transport and storage and so on.
This section applies to a blood analyzer with dilution.
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 ± 0.20 in nominal value range.
3.4 Conductivity
Conductivity (ρ) shall be the nominal value within ± 50mS/m range.
3.5 osmolality
Osmolarity should be the nominal value within ± 10mmol/L (mOsm/kg) range.
3.6 Particle Counting
Particle counting shall comply with the requirements of Table 1.
Table 1 Particle Counting Requirements
Particle volume particle counting
≥2.5fL ≤2.5 × 105/L
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