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YY/T 0456.1-2014: Reagents for hematology analyzer. Part 1: Rinse
Status: Obsolete YY/T 0456.1: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0456.1-2014 | English | 239 |
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Reagents for hematology analyzer. Part 1: Rinse
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YY/T 0456.1-2014
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| YY/T 0456.1-2003 | English | 319 |
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Regents for hematology analyzer use-Part 1: Rinse
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YY/T 0456.1-2003
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PDF similar to YY/T 0456.1-2014
Basic data | Standard ID | YY/T 0456.1-2014 (YY/T0456.1-2014) | | Description (Translated English) | Reagents for hematology analyzer. Part 1: Rinse | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 6,631 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Older Standard (superseded by this standard) | YY/T 0456.1-2003 | | Quoted Standard | GB/T 191 | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30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 cleaning fluid. This Standard specifies the hematology analyzer with cleaning fluid requirements, test methods, marking, labeling and instructions for use, packaging, transport and storage and so on. | YY/T 0456.1-2014: Reagents for hematology analyzer. Part 1: Rinse---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 1. Rinse
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0456.1-2003
Blood analyzer reagent
Part 1. cleaning solution
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 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 × 109/L" changed to "≤0.5 × 109/L", red blood cell count "≤0.10 ×
1012/L "changed to" ≤0.05 × 1012/L ", platelet count" ≤20 × 109/L "changed to" ≤10 × 109/L ", adds
Hemoglobin "≤2g/L" requirement;
--- Remove the cleaning rate;
--- Batch difference between claims "ΔpH≤0.50" changed to "ΔpH≤0.60".
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.
The main drafters of this section. Yang Zongbing, Xuwen Juan, Zhang Zhao Park, Xiao Yan, Yin Qi Man.
This section was first released in 2003.
Blood analyzer reagent
Part 1. cleaning solution
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
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 ± 0.30 in nominal value range.
3.4 Blank Count
Blank count shall conform to the requirements of Table 1.
Table 1 Blank count requirements
Test project requirements
White blood cell count (WBC) ≤0.5 × 109/L
Red blood cell count (RBC) ≤0.05 × 1012/L
Hemoglobin (HGB) ≤2g/L
Platelet count (PLT) ≤10 × 109/L
3.5 Batch difference between
ΔpH difference between the pH of the batch should be less than 0.60.
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