YY/T 0456.4-2014Reagents for hematology analyzer - Part 4: Nucleated red blood cell enumeration reagents (English PDF)
血液分析仪用试剂 第4部分:有核红细胞检测试剂
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 0456.4-2014 is the English-translated version of 血液分析仪用试剂 第4部分:有核红细胞检测试剂.
YY/T 0456.4-2014 is the Chinese pharmaceutical industry standard for the reagent used with a haematology analyzer to enumerate nucleated red blood cells.
It is the fourth part of the YY/T 0456 series and specifies the classification, the requirements, the test methods, the marking, the labelling, the instructions and the rules for packaging, transport and storage, covering the appearance, the accuracy and repeatability of the count, the agreement with the reference method, the carry-over and the stability. Issued on 17 June 2014, it has applied since 1 July 2015.
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Document preview — YY/T 0456.4-2014
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 4 Requirements
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.
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
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Related Standards
GB/T 191-2000 — Packaging-Pictorial marking for handling of goods
GB/T 191-2008 — Packaging - Pictorial marking for handling of goods
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
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