YY/T 1204-2021 English PDF

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YY/T 1204-2021: Total bile acids assay kit (enzyme cycle method)
Status: Valid

YY/T 1204: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1204-2021	159	Add to Cart	3 days	Total bile acids assay kit (enzyme cycle method)	Valid
YY/T 1204-2013	399	Add to Cart	3 days	Total bile acids assay kit(Enzyme cycle method)	Obsolete

Similar standards

YY/T 1200   YY/T 1200   YY/T 1206   YY/T 1199   

Basic data

Standard ID: YY/T 1204-2021 (YY/T1204-2021)
Description (Translated English): Total bile acids assay kit (enzyme cycle method)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Word Count Estimation: 8,842
Issuing agency(ies): State Drug Administration

YY/T 1204-2021: Total bile acids assay kit (enzyme cycle method)

---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.
Total bile acids assay kit (enzyme cycle method) ICS 11:100:10 CCSC44 People's Republic of China Pharmaceutical Industry Standard Replace YY/T 1204-2013 Total bile acid assay kit (enzyme cycle method) Published on 2021-12-06 2022-12-01 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 of Standardization Documents" drafted: This document replaces YY/T 1204-2013 "Total Bile Acid Determination Kit (Enzyme Cycle Method)", compared with YY/T 1204-2013, the main The technical changes are as follows: --- Added normative reference document GB/T 29791:2 (see Chapter 2); --- Changed the measurement principle (see Chapter 4, Chapter 3 of the:2013 edition); --- Changed the item name of 5:2, and changed "loading amount" to "net content" (see 5:2, 4:2 of the:2013 edition); --- Changed the requirements and corresponding testing methods (see 5:3~5:8 and 6:3~6:8, 4:3~4:8 and 5:8 of the:2013 edition); --- Changed the provisions of labels and instructions for use (see Chapter 7, Chapter 6 of the:2013 edition); --- Changed the regulations on packaging, transportation and storage (see Chapter 8, Chapter 7 of the:2013 edition): Please note that some content of this document may be patented: 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 Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136): This document is drafted by: China National Institute for Food and Drug Control, Henan Medical Device Inspection Institute, Shanghai Clinical Inspection Center, Meikangsheng Biotechnology Co:, Ltd:, Dirui Medical Technology Co:, Ltd:, Beijing Leadman Biochemical Co:, Ltd:, Jiangxi Tekang Technology Co:, Ltd: Company, Shanghai Kehua Bioengineering Co:, Ltd:, Desay Diagnostic System (Shanghai) Co:, Ltd: The main drafters of this document: Yu Ting, Zhang Juanli, Wang Hualiang, Euro Zhu, Shen Min, Chang Shuqin, Ren Yikun, Ouyang Minyong, Chen Hanyan, Zou Yanfang, Li Weijia, Huang Jie, Qu Shoufang, Sun Nan: The previous versions of this document and its superseded documents are as follows: ---First published in:2013 as YY/T 1204-2013; ---This is the first revision: Total bile acid assay kit (enzyme cycle method)

1 Scope

This document specifies the determination principles, requirements, test methods, labels and instructions for use, packaging packaging, transportation and storage: This document applies to the kit for the quantitative determination of total bile acids in human serum or plasma by the enzyme cycle method (hereinafter referred to as the reagent): kits), including reagents used on manual and semi-automatic, fully automatic biochemical analyzers:

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document: GB/T 191 Graphical signs of packaging, storage and transportation GB/T 29791:2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2: In vitro diagnostic reagents for professional use

3 Terms and Definitions

There are no terms and definitions that need to be defined in this document:

4 Measurement principle

Bile acids are characterized by 3α-hydroxysteroid dehydrogenase (3α-HSD) and thiooxidized nicotinamide adenine dinucleotide (Thio-NAD) Heterotropic oxidation produces 3α-ketosteroids (3α-KS) and thioreduced nicotinamide adenine dinucleotide (Thio-NADH): Generated In the presence of 3α-HSD and reduced coenzyme I (NADH), 3α-KS produces bile acid and oxidized coenzyme I (NAD): so cycle A large amount of Thio-NADH is produced by the reciprocation: Thio-NADH has an absorption peak near the wavelength of 405 nm, and within a certain reaction time, its light absorption The change of the calibrator is proportional to the total bile acid concentration, and the total bile acid content is calculated according to the change rate of the absorbance of the calibrator:

5 Requirements

5:1 Appearance The manufacturer should specify the appropriate appearance requirements according to the packaging characteristics of the product: Generally, there should be the composition and properties of each component of the kit; the inner and outer packaging, Requirements for clear labels, etc: 5:2 Net content The net content of liquid reagents should not be less than the marked value: 5:3 Reagent blank 5:3:1 Reagent blank absorbance Under the conditions of the test dominant wavelength (recommended 405nm) and optical diameter of 1:0cm specified by the manufacturer, the blank absorbance should not be greater than 0:80: ......

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