Path: Home > YY/T > Page2 > YY/T 0456.3-2014

Price & Delivery

US$169.00 · In stock · Download in 9 seconds
YY/T 0456.3-2014: Reagents for hematology analyzer. Part 3: Diluent
Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure
Status: Valid

Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 0456.3-2014	English	169	Add to Cart	3 days [Need to translate]	Reagents for hematology analyzer. Part 3: Diluent
YY/T 0456.3-2003	English	319	Add to Cart	3 days [Need to translate]	Regents for hematology analyzer use-Part 3: Diluent

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 ...