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YY/T 1228-2014: Albumin test reagent kit
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1228-2014 | English | 259 |
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Albumin test reagent kit
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YY/T 1228-2014
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Basic data | Standard ID | YY/T 1228-2014 (YY/T1228-2014) | | Description (Translated English) | Albumin test reagent kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 11,191 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Quoted Standard | GB 3100; YY/T 0316; YY/T 0466.1 | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to the use of bromocresol green method, bromocresol purple method for serum, plasma and other body fluids albumin quantitative detection of albumin assay reagent (box). This Standard specifies the albumin assay reagent (box) requirem | YY/T 1228-2014: Albumin test reagent kit---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.
Albumin test reagent kit
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Albumin assay reagent (kit)
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Distribution of this document
Institutions do not assume the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Beijing Medical Device Testing, Shanghai Rongsheng Sheng-Pharmaceutical Co., Ltd., Beijing Leadman Biochemistry Co. Shares
Company, Beijing Branch Medical Technology Co., Ltd. Kang Datai.
The main drafters of this standard. Yangzong Bing, Zhang Zhengjiang, Duhai Ou, Wang Lanzhen, Wang Li.
Albumin assay reagent (kit)
1 Scope
This standard specifies the albumin assay reagent (kit) requirements, test methods, labels, brochures, packaging, transportation and storage.
This standard applies to measuring albumin using bromocresol green method, bromocresol purple method for serum, plasma and other body fluids quantitative detection of albumin
Given reagent (box), including manual reagents and on the semi-automatic biochemical analyzer used.
This standard does not apply to dry chemical assay reagents.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB 3100 International System of Units and Its Application
YY/T 0316 Medical Devices Risk Management for Medical Device Applications
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
3 Requirements
3.1 Appearance
In line with the provisions of the company's normal appearance requirements.
3.2 PACKING
Not less than the indicated value.
3.3 reagent blank absorbance
Producers meet the requirements specified.
3.4 Sensitivity Analysis
Producers meet the requirements specified.
3.5 Linear Interval
Serum samples were tested in a linear reagent [10.0,60.0] g/L range.
a) The linear correlation coefficient ︱r︱ not less than 0.990;
b) within [10.0,20.0] g/L range, linearity deviation should be ± 4.0g/L within the range;
[20.1,60.0] in the g/L range, linearity deviation should not exceed ± 10.0%.
3.6 Precision
3.6.1 Repeatability
Repeat the test concentrations (40 ± 5) g/L of serum control, the results of the repeatability (coefficient of variation, CV) should not exceed 2.0%.
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