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YY/T 1199-2023: (Triglyceride Determination Kit (Enzymatic Method))
Status: Valid YY/T 1199: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1199-2023 | English | 169 |
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(Triglyceride Determination Kit (Enzymatic Method))
| Valid |
YY/T 1199-2023
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| YY/T 1199-2013 | English | 359 |
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Triglycerides assay kit (Oxidase method)
| Obsolete |
YY/T 1199-2013
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PDF similar to YY/T 1199-2023
Standard similar to YY/T 1199-2023 YY/T 1200 YY/T 1198 YY/T 1197 YY/T 1204 Basic data | Standard ID | YY/T 1199-2023 (YY/T1199-2023) | | Description (Translated English) | (Triglyceride Determination Kit (Enzymatic Method)) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 8,867 | | Date of Issue | 2023-01-13 | | Date of Implementation | 2023-07-15 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, test methods, labels, labels and instructions for use, packaging, transportation and storage of triglyceride determination kits (enzymatic method). This standard applies to the quality control of the triglyceride determination kit (enzymatic method) based on the principle of spectrophotometry. | YY/T 1199-2023: (Triglyceride Determination Kit (Enzymatic 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.
ICS 11.100.10
CCSC44
Pharmaceutical Industry Standard of the People's Republic of China
Replacing YY/T 1199-2013
Triglyceride Determination Kit (Enzymatic Method)
Released on 2023-01-13
2023-07-15 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.
This document replaces YY/T 1199-2013 "Triglyceride Determination Kit (Enzymatic Method)". Compared with YY/T 1199-2013, except for the structure
In addition to adjustments and editorial changes, the main technical changes are as follows.
a) Modified the requirements for the linear interval (see 4.4, 4.4 of the.2013 edition);
b) Modified the accuracy requirements (see 4.5, 4.5 of the.2013 edition).
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 Medical Device Inspection Institute, Chongqing Medical Device Quality Inspection
Center, Zhongsheng Beikong Biotechnology Co., Ltd., Beijing Leadman Biochemical Co., Ltd., Mike Biological Co., Ltd., Roche Diagnostics
Broken Products (Shanghai) Co., Ltd., Siemens Medical Diagnostic Products (Shanghai) Co., Ltd., Shenzhen Mindray Biomedical Electronics Co., Ltd.
The main drafters of this standard. Gao Fei, Chen Lijuan, Lan Hualin, Jin Ling, Ren Yikun, Shi Lijuan, Lai Lianlian, Han Hui, Wan Xianzi, Huang Jie.
The release status of previous versions of this document and the documents it replaces are as follows.
---First published as YY/T 1199-2013 in.2013;
--- This is the first revision.
Triglyceride Determination Kit (Enzymatic Method)
1 Scope
This document specifies the requirements, test methods, identification, labeling and instructions for use, packaging, and transportation of triglyceride determination kits (enzymatic method)
and storage etc.
This document is applicable to the quality control of the triglyceride determination kit (enzymatic method) based on the principle of spectrophotometry, which is used for in vitro determination
Quantitative determination of the amount of triglycerides (TG) in human serum or plasma.
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 icons
GB/T 29791.1 Information provided by manufacturers of in vitro diagnostic medical devices (labelling) Part 1.Terms, definitions and general
Require
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
The terms and definitions defined in GB/T 29791.1 apply to this document.
4 requirements
4.1 Appearance
The appearance requirements of the kit should be specified. Visual inspection, the appearance should at least meet the following conditions.
a) Reagent (box) components are complete;
b) The appearance of the packaging is clean, without leakage or damage;
c) Signs and labels are clearly written.
4.2 Net content
The net content of the liquid reagent should not be less than the marked amount.
4.3 Reagent blank
The absorbance of the reagent blank should not be greater than 0.2 (at the wavelength specified by the manufacturer, at 37°C, with an optical path of 1.0cm).
4.4 Linear intervals
In the interval [0.45,9.04]mmol/L, the linear correlation coefficient r should be ≥0.9900.
In the interval [0.45,2.00]mmol/L, the absolute deviation of linearity should be within the range of ±0.2mmol/L.
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