YY/T 1592-2018 in English

VALID

ABO forward blood grouping and RhD typing reagents(column agglutination technique,CAT)

Issued on:2018-02-24
Implemented on:2019-03-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $160.00
$156.00

Standard No:	YY/T 1592-2018
Document status:	VALID
Title in English:	ABO forward blood grouping and RhD typing reagents(column agglutination technique,CAT)
Title in Chinese:	ABO正定型和RhD血型定型检测卡（柱凝集法）
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2018-02-24
Implemented on:	2019-03-01
ICS Classification:	11.040.30-Surgical instruments and materials
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	YY-Pharmaceutics
Related Keywords:	rhd blood typing cards column agglutination technique column agglutination method blood typing cards blood transfusion
Related Topics:	Serotype detection method Formal Periodic Testing Gel column peak type calibration set test set Hemagglutination test cup calibration set test set Blood typing reagents abo blood type Four coagulation tests Blood typing reagents blood clot detection Calibration set Test set abo blood type according to rhd rhd blood type Human abo blood type detection coagulation test blood blood group agglutination test blood group agglutination test abo blood type abo blood type test blood type test card Blood fluoride test The positive and negative stereotypes of blood types do not match Method for determination of minimum concentration of lectin agglutination Blood type identification industry Blood type test fee Coagulometer testing methods do not include Blood coagulation cup test ny/t 1592 yy/t1630-2018 Bombay blood group identification method Principle of reverse typing blood typing method yy/t 1592-2018 yy/t1615-2018

本标准规定了ABO正定型和RhD血型定型检测卡（柱凝集法）的要求、试验方法、标识、标签、使用说明书、包装、运输和贮存。
本标准适用于使用凝胶、玻璃微珠等材料进行填充微柱，以免疫血液学、颗粒过筛和离心技术三者结合为原理，进行临床红细胞ABO血型系统的正定型鉴定和Rh系统中正常D抗原的检测。
本标准不适用于血源筛查进行ABO正定型和RhD血型鉴别的诊断试剂。

Introduction

This standard specifies the requirements for the performance, design, labeling, and testing of ABO and RhD blood typing cards using the column agglutination method. It covers aspects such as the materials used, the accuracy of the test results, the stability of the product under various storage conditions, and the instructions for use. The standard also outlines the methods for validation and verification of the blood typing cards to ensure their reliability and consistency. It provides detailed guidelines for manufacturers to ensure that their products meet the necessary quality and safety standards for use in blood transfusion and related clinical applications. The scope includes the entire lifecycle of the product from development through to post-market surveillance.

*** Please note: This description may not be accurate, please refer to the official documentation.

More samples: GB 50021-2001(2009) DL/T 368-2010 NB/T 47013.2-2015

Sample only — not a preview of YY/T 1592-2018

Loading PDF document...

Error loading PDF. Please make sure the file is valid and try again.

We also recommend

YY/T 1940-2024 in English

Medical Nitinol Powders for Additive Manufacturing
2024-09-29
YY/T 1214-2019 in English

Human chorionic gonadotrophin detection kit
2019-07-24
YY/T 0993-2015 in English

Biological evaluation of medical devices―Nanomaterial:In vitro cytotoxicity tests(MTT assay and LDH assay)
2015-03-02