YY/T 1238-2014RhD(IgM) blood grouping reagent(monoclonal antibody) (English PDF)
RhD（IgM)血型定型试剂（单克隆抗体）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 1238-2014 is the English-translated version of RhD（IgM)血型定型试剂（单克隆抗体）.
YY/T 1238-2014 is the Chinese pharmaceutical industry standard for the RhD blood grouping reagent of the IgM monoclonal antibody type.
It specifies the composition of the reagent, the requirements, the test methods, the marking, the instructions for use and the rules for packaging, transport and storage, covering the appearance, the specificity and the avidity, the titre and the reaction time, the absence of unwanted antibodies, the agreement with the national reference materials and the stability. Issued on 17 June 2014, it has applied since 1 July 2015.
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Document preview — YY/T 1238-2014
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
- 3 Reagent Composition
- 4 Requirements
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
1 Scope
This standard specifies the RhD (IgM) blood grouping reagents (monoclonal antibody) reagent composition, requirements, test methods, marking, instructions for use Books, packaging, transportation and storage.
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. Three Chinese Pharmacopoeia 2010 Edition
3 Reagent Composition
Reagent by the RhD (IgM) blood grouping reagents (monoclonal antibodies) components.
4 Requirements
4.1 Appearance
It should be colorless or light yellow transparent liquid without shaking ghost precipitation and foreign matter.
4.2 PACKING
It should not be less than the labeled amount.
4.3 pH
It should be 6.0 to 9.0.
4.4 Specific
Use standard spectrum erythrocytes (containing at least two cases of Rh-negative cells) detected with RhD-positive red blood cells should appear agglutination with RhD Agglutination of red blood cells should not be negative.
4.5 Titer
Not less than 1.64.
4.6 Affinity
Agglutination time should not exceed 15s; 3min within aggregates should be not less than 1mm².
4.7 Thermal Stability
This test should be carried out before the product is shipped, the results should meet the requirements of 4.4,4.5,4.6.
......
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
PRC Pharmacopoeia 2010 edition (Volume 3)
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