HOME   Cart(0)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189759 (19 Oct 2025)

YY/T 1592-2018 English PDF

US$179.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1592-2018: ABO forward blood grouping and RhD typing reagents(column agglutination technique, CAT)
Status: Valid
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 1592-2018English179 Add to Cart 3 days [Need to translate] ABO forward blood grouping and RhD typing reagents(column agglutination technique, CAT) Valid YY/T 1592-2018

PDF similar to YY/T 1592-2018


Standard similar to YY/T 1592-2018

YY/T 1651.1   YY/T 1630   YY/T 1555.2   YY/T 1593   YY/T 1591   

Basic data

Standard ID YY/T 1592-2018 (YY/T1592-2018)
Description (Translated English) ABO forward blood grouping and RhD typing reagents(column agglutination technique, CAT)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.30
Word Count Estimation 9,940
Date of Issue 2018-02-24
Date of Implementation 2019-03-01
Quoted Standard GB/T 191; GB/T 29791.2
Regulation (derived from) China Food and Drug Administration announced No. 27 of 2018
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the requirements, test methods, labels and instructions, packaging, transportation, and storage of the ABO positive and RhD blood typing test cards (column agglutination method). This standard applies to the use of gels, glass beads and other materials to fill the micro-column, immunohistochemistry, particle screening and centrifugation techniques for the principle of positive red blood cell ABO blood type system identification and Rh system normal D antigen detection. This standard does not apply to blood source screening for ABO positive and RhD blood type diagnostic reagents.

YY/T 1592-2018: ABO forward blood grouping and RhD typing reagents(column agglutination technique, CAT)


---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.
ABO forward blood grouping and RhD typing reagents (column agglutination technique, CAT) ICS 11.040.30 C30 People's Republic of China Pharmaceutical Industry Standard ABO positive stereotype and RhD blood type stereotype test card (column agglutination method) (columnagglutinationtechnique, CAT) Published on.2018-02-24 2019-03-01 implementation State Food and Drug Administration issued

Content

Foreword I 1 Scope 1 2 Normative references 1 3 Requirements 1 4 Test method 2 5 Labels and instructions 3 6 Packaging, transportation and storage 3 Appendix A (normative appendix) ABO positive-type and RhD blood type stereotype test card (colum agglutination method) raw material data requirements 4 Appendix B (informative) A1 type, A2 type, B type, O type, RhD positive and RhD negative reagent red blood cell quality requirements 5 Reference 6

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136). This standard was drafted. China Food and Drug Control Research Institute, Shanghai Blood Biomedical Co., Ltd., Jiangyin Libo Pharmaceutical Technology Co., Ltd., Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd., Changchun Boxun Biotechnology Co., Ltd. The main drafters of this standard. Shen Shu, Zhang Chuntao, Zhan Shenhong, Chen Yuping, Yan Xin, Chen Weijia. ABO positive stereotype and RhD blood type stereotype test card (column agglutination method)

1 Scope

This standard specifies the requirements, test methods, labels and instructions for the ABO positive stereotype and RhD blood type stereotype test card (column agglutination method). Packaging, transportation and storage. This standard applies to the use of gels, glass beads and other materials to fill the microcolumn, immunological hematology, particle sieving and centrifugation technology Based on the principle, positive identification of the clinical red blood cell ABO blood group system and detection of normal D antigen in the Rh system were performed. This standard does not apply to blood source screening for diagnostic reagents for ABO positive typing and RhD blood type identification.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191 packaging storage and transportation icon GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents

3 requirements

3.1 Appearance The anti-A column should be blue, the anti-B column should be yellow, and the anti-D column should be colorless or yellowish; each column should be free of cracks, and the surface of the inner filling should be There is a liquid layer, and there should be no impurities in the column packing and liquid; after centrifugation, there should be no air bubbles, and the surface of the filler should not be significantly inclined. 3.2 Specificity Each column of the test card shall comply with the following regulations. a) Anti-A column should be positively reacted with A1 type, A2 type, A2B type reagent red blood cells, and negative with B type and O type reagent red blood cells reaction. b) Anti-B column should be positively reacted with B-type and A2B-type reagent red blood cells, and negative with A1 type, A2 type, O-type reagent red blood cells reaction. c) Anti-D column should be positively reacted with normal RhD positive reagent red blood cells, and negative reaction with RhD negative reagent red blood cells. d) All positive reactions should not have a mixed reaction such as a double group phenomenon. All negative reactions should not be difficult to distinguish by agglutination, hemolysis, etc. Note 1. Normal RhD-positive red blood cells refer to RhD-positive red blood cells that do not include RhD antigen variants. The same below. Note 2. The indistinguishable phenomenon of the negative reaction includes red blood cell tailing visible to the naked eye in the column. 3.3 Sensitivity Each column of the test card shall comply with the following regulations. a) When the anti-A column and the A1 type reagent red blood cells agglutinate, the reaction intensity should be not less than 4; with the A2 type and AB type reagent red When the cells undergo agglutination, the reaction intensity should be not less than 3. b) When the anti-B column and the B-type reagent red blood cells agglutinate, the reaction intensity should be not less than 4; and the AB-type reagent red blood cells occur

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1592-2018_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1592-2018_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1592-2018_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1592-2018_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.