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YY/T 0456.4-2014: Reagents for hematology analyzer. Part 4: Nucleated red blood cell enumeration reagents
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0456.4-2014 | English | 169 |
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Reagents for hematology analyzer. Part 4: Nucleated red blood cell enumeration reagents
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YY/T 0456.4-2014
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Basic data | Standard ID | YY/T 0456.4-2014 (YY/T0456.4-2014) | | Description (Translated English) | Reagents for hematology analyzer. Part 4: Nucleated red blood cell enumeration reagents | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 7,798 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | 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 blood analyzers NRBC detection reagent. This Standard specifies the hematology analyzer with NRBC detection reagents classification, requirements, test methods, marking, labeling and instructions for use, packaging, transport and | YY/T 0456.4-2014: Reagents for hematology analyzer. Part 4: Nucleated red blood cell enumeration reagents
---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 4. Nucleated red blood cell enumeration reagents
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Blood analyzer reagent
Part 4. nucleated red blood cell detection reagents
Part 4. Nucleatedredbloodcelenumerationreagents
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 40456 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
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. Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Beijing Medical Device Testing, Jiang Xi Tekang science and technology have
Ltd., Sysmex Medical Electronics (Shanghai) Co., Ltd.
The main drafters of this section. Xuwen Juan, Yang Zongbing, Duhai Ou, Xiao Yan, Li Ling.
Blood analyzer reagent
Part 4. nucleated red blood cell detection reagents
1 Scope
YY/T 0456 provisions of this part of the blood analyzer with NRBC detection reagent classification, requirements, test methods, sign, label
Sign and instructions, packaging, transport and storage and so on.
This section applies to a blood analyzer with NRBC detection reagents.
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
Category 3
3.1 Classification
NRBC detection reagent may be a reagent, can also be supporting the use of a set of reagents required, according to the principle of differential detection
Divided into.
a) non-staining nucleated red blood cell detection reagents;
b) chemical staining nucleated red blood cell detection reagents;
c) staining nucleated red blood cell detection reagent.
4 Requirements
4.1 Appearance
It should be a clear liquid, without precipitation, and particles or floc.
4.2 PACKING
It should not be less than the nominal value.
4.3 pH
Having a diluted sample or sample processing effects NRBC detection reagents, pH should be within ± 0.20 nominal value range.
4.4 osmolality
Having a diluted sample or sample processing effects NRBC detection reagent concentration should permeate the nominal value ± 20mmol/L
Internal (mOsm/kg) range.
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