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YY/T 1238-2014 PDF English

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YY/T 1238-2014: RhD(IgM) blood grouping reagent (monoclonal antibody)
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YY/T 1238-2014English189 Add to Cart 3 days [Need to translate] RhD(IgM) blood grouping reagent (monoclonal antibody)

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Basic data

Standard ID YY/T 1238-2014 (YY/T1238-2014)
Description (Translated English) RhD(IgM) blood grouping reagent (monoclonal antibody)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 8,818
Date of Issue 6/17/2014
Date of Implementation 7/1/2015
Quoted Standard PRC Pharmacopoeia 2010 edition (Volume 3)
Adopted Standard PRC Pharmacopoeia 2010 edition (Volume 3)
Regulation (derived from) China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies) State Food and Drug Administration
Summary This Standard applies to RhD (IgM) blood grouping reagents (monoclonal antibody). This Standard specifies the RhD (IgM) blood grouping reagents (monoclonal antibody) test project and requirements.

YY/T 1238-2014: RhD(IgM) blood grouping reagent (monoclonal antibody)


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
RhD (IgM) blood grouping reagent (monoclonal antibody) ICS 11.100 C44 People's Republic of China pharmaceutical industry standards RhD (IgM) blood grouping reagents (monoclonal antibody) Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Distribution of this document Institutions do not assume the responsibility to identify these patents. This standard was proposed by the China Food and Drug Administration. This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized. This standard drafting unit. China Academy of Food and Drug test. The main drafters of this standard. Ma Qiuping, tube Lei Tung, Hou Jifeng. RhD (IgM) blood grouping reagents (monoclonal antibody)

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. ...

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