GA 475-2004Serum product of anti-human serum (English PDF)
抗人血清试剂
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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 475-2004 is the English-translated version of 抗人血清试剂.
GA 475-2004 — This standard stipulates the quality requirements, testing methods and testing rules of anti-human serum reagents used by the doctors for physical and mental testing.
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 475-2004
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, Xie Qun, Zhang Haibing, Li Zhaolong, Zhang Yinglan, Qi Yingsong, Wu Bozhen.
Anti-human serum reagent
1 Scope
This standard stipulates the quality requirements, testing methods and testing rules of anti-human serum reagents used by the doctors for physical and mental testing.
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 a serum species to determine whether a biological sample to be tested contains human serum.
4 Reagent classification
4.1 Lyophilization reagent.
4.2 Liquid reagents.
5 Quality requirements
5.1 Appearance characteristics
5.1.1 Anti-human serum reagent is a light yellow transparent liquid.
5.1.2 Freeze-dried anti-human serum reagent is light yellow loose body. After adding the indicated amount of dissolved solution, it should be completely dissolved into light yellow transparent within 2 minutes.
liquid.
5.2 Cyclic precipitation test serum titer
The anti-human serum reagent should reach 10,000 times in 60 minutes.
5.3 Specificity
Within 60 min, no precipitation ring appeared in.200-fold serum dilutions 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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