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GA 472-2004Serum product of anti-human hemoglobin (English PDF)

抗人血红蛋白血清试剂

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Issued by

Ministry of Public Security of the People Republic of China

Level / Type

National · Mandatory

Issue date

March 16, 2004

Implementation date

July 1, 2004

Scope

GA 472-2004 is the English-translated version of 抗人血红蛋白血清试剂.

GA 472-2004 — This standard specifies the quality requirements, testing methods and testing rules for anti-human hemoglobin serum reagents used in the examination of medical doctor samples.

This standard is applicable to the production, inspection and trade of special reagents for human blood (plaque) species test of medical doctors.

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Document preview — GA 472-2004

National Standard of the People's Republic of China

ICS
13.310
Classification
A 92

Issued by: Ministry of Public Security of the People Republic of China

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 4 Reagent classification
  • 5 Quality requirements
  • 5.1 Appearance characteristics
  • 5.2 Cyclic precipitation test serum titer
  • 5.3 Specificity
  • 5.4 Pathogenic microorganisms
  • 6 Marking, packaging, transportation, storage
  • 6.1 Mark

Foreword

The full technical content of this standard is mandatory.

This standard is proposed and managed by the National Criminal Technology Standardization Committee.

This standard was drafted. Ministry of Public Security Material Identification Center.

Drafters of this standard. Wen Peizhong, Cheng Weiwei, Xie Qun, Zhang Chunhuan, Zhang Haibing, Li Zhaolong, Zhang Yinglan, and Ying Yingsong.

Anti-human hemoglobin serum reagent

1 Scope

This standard specifies the quality requirements, testing methods and testing rules for anti-human hemoglobin serum reagents used in the examination of medical doctor samples.

This standard is applicable to the production, inspection and trade of special reagents for human blood (plaque) species test of medical doctors.

2 Normative references

The terms in the following documents become the terms of this standard by reference to this standard. All dated references, followed by all Modifications (not including errata content) or revisions do not apply to this standard, however, parties to agreements based on this standard are encouraged to study is it possible to use the latest version of these files? For undated references, the latest edition applies to this standard.

GB/T 2828.1-2003 - Sampling procedures for sampling by sampling - Part 1 Plan (ISO 2859-1:1999, IDT)

3 Terms and definitions

This standard uses the following terms and definitions.

An agent for testing blood-stained species to determine whether a biological sample to be tested contains human hemoglobin.

4 Reagent classification

4.1 Lyophilization reagent.

4.2 Liquid reagents.

5 Quality requirements

5.1 Appearance characteristics

5.1.1 Anti-human hemoglobin serum reagent is a light yellow transparent liquid.

5.1.2 Freeze-dried anti-human hemoglobin serum reagent is light yellow loose body. After adding the labeled amount of solution, it should be completely dissolved in 2min.

Yellow transparent liquid.

5.2 Cyclic precipitation test serum titer

The anti-human hemoglobin serum reagent titer should reach 10,000 times within 60 minutes.

5.3 Specificity

Within 60 min, there was no precipitation ring in the.200-fold hemoglobin dilution of common animals such as dogs, cattle, sheep, horses, chickens, and the like.

5.4 Pathogenic microorganisms

There should be no hepatitis B virus, syphilis, and HIV pollution.

6 Marking, packaging, transportation, storage

6.1 Mark

The packaging should have the following signs.

a) the name of the reagent;

b) potency;

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 4 pages — is available in the English PDF.

Referenced standards

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