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YY/T 0456.3-2014Reagents for hematology analyzer - Part 3: Diluent (English PDF)

血液分析仪用试剂 第3部分:稀释液

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 17, 2014

Implementation date

July 1, 2015

Scope

YY/T 0456.3-2014 is the English-translated version of 血液分析仪用试剂 第3部分:稀释液.

YY/T 0456.3-2014 is the Chinese standard "Reagents for hematology analyzer - Part 3: Diluent". Its scope clause reads: 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. Its clauses include requirements.

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Document preview — YY/T 0456.3-2014

National Standard of the People's Republic of China

ICS
11.100
Classification
C 44
Replacing
YY/T 0456.3-2003

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • 1 Scope
  • 2 Normative references
  • 3 Requirements
  • 3.1 Appearance
  • 3.2 PACKING
  • 3.3 pH
  • 3.4 Conductivity
  • 3.5 osmolality
  • 3.6 Particle Counting

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 (rho) 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 […]

......
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

Similar standards

Editions of YY/T 0456.3

EditionTitleRevisionStatus
YY/T 0456.3-2014Reagents for hematology analyzer - Part 3: Diluentcurrent editionCurrent
YY/T 0456.3-2003Reagents for hematology analyzer - Part 3: Diluentprevious editionSuperseded

This page sells the current edition, YY/T 0456.3-2014. Earlier editions are listed for reference only.

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