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YY/T 0456.5-2014 PDF English

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YY/T 0456.5-2014: Reagents for hematology analyzer. Part 5: Reticulocyte enumeration reagents
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YY/T 0456.5-2014English169 Add to Cart 3 days [Need to translate] Reagents for hematology analyzer. Part 5: Reticulocyte enumeration reagents

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Basic data

Standard ID YY/T 0456.5-2014 (YY/T0456.5-2014)
Description (Translated English) Reagents for hematology analyzer. Part 5: Reticulocyte enumeration reagents
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 7,748
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 hematology analyzer with reticulocyte detection reagent. This Standard specifies the hematology analyzer with reticulocyte detection reagents classification, requirements, test methods, marking, labeling and instructions for use,

YY/T 0456.5-2014: Reagents for hematology analyzer. Part 5: Reticulocyte 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 5. Reticulocyte enumeration reagents ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Blood analyzer reagent Part 5. reticulocyte detection reagents 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 50456 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, the United States Beckman Coulter Special Limited Jiang Xi Tekang Technology Co., Ltd., Sysmex Medical Electronics (Shanghai) Co., Ltd. The main drafters of this section. Xuwen Juan, Yangzong Bing, Yin Qi Man, Duhai Ou, Xiao Yan, Li Ling. Blood analyzer reagent Part 5. reticulocyte detection reagents

1 Scope

YY/T 0456 provisions of this part of the hematology analyzer with reticulocyte 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 reticulocyte detection reagent.

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 Reticulocyte detection reagent may be a reagent, the reagent may be necessary to use a set, according to the detection principle of differential Divided into. a) non-staining French reticulocyte detection reagents; b) staining French reticulocyte detection reagents; c) staining French reticulocyte detection reagent.

4 Requirements

4.1 Appearance It should be a clear liquid, without precipitation, 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 action reticulocyte detection reagents, pH should be in the range of ± 0.20 nominal value. 4.4 osmolality Having a diluted sample or sample processing action reticulocyte detection reagent concentration should permeate the nominal value ± 20mmol/L Internal (mOsm/kg) range. ...

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