Search result: YY/T 1229-2014
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Calcium test reagent kit
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YY/T 1229-2014
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| Standard ID | YY/T 1229-2014 (YY/T1229-2014) | | Description (Translated English) | Calcium 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 | 11,168 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Quoted Standard | GB 3100; YY/T 0316; YY/T 0466.1 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to the use of calcium Arsenazo �� law, o copper phthalocyanine complex method, methyl thymol blue method for serum, plasma and other body fluids calcium quantitative detection of the assay reagent (box), including manual reagents and |
YY/T 1229-2014
Calcium test reagent kit
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Calcium 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 Fuxing Changzheng Medical Science Co., Beckman Coulter commerce (in
Country) Co., InTec (Xiamen) Technology Co., Ltd., Hitachi High-Technologies (Shanghai) International Trade Co., Ltd. Beijing Branch.
The main drafters of this standard. Yangzong Bing, Wu Jie, Liu Chiu, Du Jiao, Zhang Yongmei, Duhai Ou.
Calcium assay reagent (kit)
1 Scope
This standard specifies the calcium assay reagent (kit) requirements, test methods, labels, brochures, packaging, transportation and storage.
This standard applies to the use of azo arsenic Ⅲ law, o-cresol copper phthalocyanine complex method, methyl thymol blue method for serum, plasma and other body fluids calcium intake
Calcium row quantitative detection assay reagent (kit), 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, o-cresol copper phthalocyanine complex method, methyl thymol blue reagent linear method in [1.00,3.75] mmol/L range, even
Nitrogen arsine Ⅲ reagent linear method in [1.00,4.00] mmol/L range.
a) The linear correlation coefficient ︱r︱ not less than 0.990;
b) in the linear range, linearity deviation should not exceed ± 10.0%.
3.6 Precision
3.6.1 Repeatability
Repeat the test concentrations (2.5 ± 0.5) mmol/L in serum control, the results of the repeatability (coefficient of variation, CV) should not exceed
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