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YY/T 1883-2023 English PDF

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YY/T 1883-2023: Rh blood system C, c, E, e blood grouping reagents(Column agglutination technique, CAT)
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YY/T 1883-2023English189 Add to Cart 3 days [Need to translate] Rh blood system C, c, E, e blood grouping reagents(Column agglutination technique, CAT) Valid YY/T 1883-2023

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Basic data

Standard ID YY/T 1883-2023 (YY/T1883-2023)
Description (Translated English) Rh blood system C, c, E, e blood grouping reagents(Column agglutination technique, CAT)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100.10
Word Count Estimation 10,110
Date of Issue 2023-03-14
Date of Implementation 2024-05-01
Issuing agency(ies) State Drug Administration
Summary This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of Rh blood group C, c, E, e antigen test card (column agglutination method). This document is applicable to microcolumns filled with materials such as gel and glass microspheres. Anti-C, c, E, and e in the microcolumns are IgM-type monoclonal antibodies. Based on the principle of the combination of the former and the four antigens of C, c, E and e in the Rh blood group system for qualitative detection. This document does not apply to diagnostic reagents for Rh blood group C, c, E, e antigen detection for blood source screening.

YY/T 1883-2023: Rh blood system C, c, E, e blood grouping reagents(Column agglutination technique, CAT)


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ICS11:100:10 CCSC44 Pharmaceutical Industry Standard of the People's Republic of China Rh blood group C, c, E, e antigen test card (column agglutination method) technique, CAT) Released on 2023-03-14 2024-05-01 Implementation Released by the State Drug Administration

foreword

This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents" drafting: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by the State Drug Administration: This document is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136): This document was drafted by: China Institute for Food and Drug Control, Jilin Provincial Institute for Medical Device Testing, Changchun Boxun Biotechnology Co:, Ltd: The responsible company, Jiangsu Libo Pharmaceutical Biotechnology Co:, Ltd:, Mike Biological Co:, Ltd:, Bole Life Medical Products (Shanghai) Co:, Ltd: Co:, Ltd:, Osendo Medical Devices Trading (China) Co:, Ltd:, Beijing Jiuqiang Biotechnology Co:, Ltd: The main drafters of this document: Hu Zebin, Chen Lijuan, Chen Weijia, Wang Buqiang, Wang Xiaobo, Hou Lei, Lu Xiongzhang, Liu He, Huang Jie: Rh blood group C, c, E, e antigen test card (column agglutination method)

1 Scope

This document specifies the requirements, test methods, labels and instructions for use of the Rh blood group C, c, E, e antigen test card (column agglutination method), package Packing, transportation and storage etc: This document is applicable to micro-columns filled with materials such as gel and glass microbeads: Antibody, using the combination of immunohematology, particle sieving and centrifugation technology, for qualitative detection of C, c, E, Reagents for the detection of e4 antigens: This document does not apply to diagnostic reagents for Rh blood group C, c, E, e antigen detection for blood source screening:

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document: GB/T 191 Packaging, storage and transportation icon marks GB/T 29791:2 Information provided by manufacturers of in vitro diagnostic medical devices (labelling) Part 2: In vitro diagnostic reagents for professional use

3 Terms and Definitions

This document does not have terms and definitions that need to be defined:

4 requirements

4:1 Appearance The anti-C column, anti-E column, anti-c column, anti-e column and quality control column in the test card should be colorless, light yellow or uniform milky white; each column should be dry There should be a liquid layer on the surface of the inner filling, and the filling and liquid of each column should be uniform without foreign matter; after centrifugation, there should be no air bubbles, and the surface of the filling should not There should be a clear slope: 4:2 Specificity Each column of the test card shall meet the following requirements: a) The anti-C column should undergo agglutination reaction with normal RhC-positive red blood cells (including C antigen homozygous and heterozygous), and with RhC-negative Red blood cells were negative: b) The anti-c column should undergo agglutination with normal Rhc-positive red blood cells (including homozygous and heterozygous c antigens), and with Rhc-negative red blood cells: Cells were negative: c) The anti-E column should undergo agglutination reaction with normal RhE positive red blood cells (including E antigen homozygous and heterozygous), and with RhE negative Red blood cells were negative: d) The anti-e column should undergo agglutination reaction with normal Rhe-positive red blood cells (including e-antigen homozygotes and heterozygotes), and with Rhe-negative red blood cells: Cells were negative:

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