YY/T 1231-2014 English PDF (YYT1231-2014)

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YY/T 1231-2014: Creatinine test reagent kit (Method of sarcosine oxidase)
YY/T 1231-2014
Creatinine test reagent kit (Method of sarcosine oxidase)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Creatinine assay reagent (kit) (sarcosine oxidase)
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, Hitachi High-Technologies (Shanghai) International Trading Co., Ltd. Beijing Branch, the
Sea Rongsheng Sheng was Pharmaceutical Co., Ltd. was Bo Dingsheng Engineering (Beijing) Co., Ltd., Abbott Trading (Shanghai) Co., Ltd.
The main drafters of this standard. Wang Jun, Bi Chunlei, Yong-Mei Zhang, Zhang Zhengjiang, Xudong Huan, Wang Xuefeng.
Creatinine assay reagent (kit) (sarcosine oxidase)
1 Scope
This standard specifies the creatinine assay reagent (kit) (sarcosine oxidase) technical requirements, test methods, labels, brochures, package
Loading, transport and storage.
This standard applies to the use of sarcosine oxidase in serum, plasma, urine creatinine concentration quantitative detection of creatinine measurement reagent
(Box), including manual reagents and on the semi-automatic biochemical analyzer used.
This standard does not apply to the determination of creatinine method picric acid reagent (box).
This standard does not apply to dry creatinine reagent (box).
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
GB/T 21415-2008 vitro diagnostic medical devices samples of biological origin quantity measurement calibration and quality control material assignment
Metrological traceability
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
Net content of the liquid reagent to be less than indicated value.
3.3 reagent blank absorbance
Reagent blank absorbance should be consistent with the company given range.
3.4 Sensitivity Analysis
Test 100μmol/L creatinine, the rate of change of the absorbance of the company in line with the given range.
3.5 Linear Interval
Test serum or plasma samples, reagent linearity [30,1500] μmol/L (37 ℃) interval.
a) The linear correlation coefficient | r | should be not less than 0.990;
b) within [30,70] μmol/L range, linearity deviation should not exceed ± 7μmol/L; inner (70,1500] μmol/L range, linear partial
The difference shall not exceed ± 10%.