YY/T 1205-2013 English PDF (YY/T1205-2013)

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YY/T 1205-2013: Total bilirubin test kit (Vanadate oxidation method)
YY/T 1205-2013
Total bilirubin test kit (Vanadate oxidation method)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Total bilirubin assay kit (vanadate oxidation method)
Issued on. 2013-10-21
2014-10-01 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 standard may involve patents. The standard release
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 drafting unit. China Academy of Food and Drug test.
The main drafters of this standard. Sun Nan, Liu Yan, Wang Yumei, the first noble, Zhangchun Tao.
Total bilirubin assay kit (vanadate oxidation method)
1 Scope
This standard specifies the total bilirubin assay kit (vanadate oxidation method) requirements, test methods, marking, labeling and instructions for use, package
Loading, transport and storage.
This standard applies to the total bilirubin assay kit (vanadate oxidation method) quality control.
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.
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
3 Requirements
3.1 Appearance
Compatible with the manufacturer's appearance requirements.
3.2 PACKING
Loading amount of the liquid reagent to be less than the labeled amount.
3.3 reagent blank absorbance
At 450nm wavelength, blank absorbance should be less than 0.050.
3.4 Linear Interval
Within the range specified by the manufacturer of the linear correlation coefficient (r) shall not be less than 0.9900.
3.5 Accuracy
Use standard product has traceability was measured relative deviation of the measured value and the value declared shall be within ± 10.0%.
3.6 Sensitivity Analysis
When test kits given concentration of analyte, change in absorbance (ΔA) shall comply with the manufacturer's given range.
3.7 Precision
3.7.1 within run precision
Intra-assay precision should be less than 5.0%.
3.7.2 Batch difference between
The difference between the grant should not exceed 10.0%.