YY/T 1205-2013 (YY/T1205-2013, YYT 1205-2013, YYT1205-2013) & related versions
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| YY/T 1205-2013 | English | 150 |
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Total bilirubin test kit (Vanadate oxidation method)
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YY/T 1205-2013
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YYT 1205-2013
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YY/T 1205-2013: PDF in English (YYT 1205-2013)
YY/T 1205-2013
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
YYY/T 1205-2013
Total bilirubin test kit (Vanadate oxidation method)
Issued by. State Food and Drug Administration
ISSUED ON. OCTOBER 21, 2013
IMPLEMENTED ON. OCTOBER 1, 2014
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Requirements ... 4
4 Test Method ... 5
5 Mark, Label and Instructions ... 7
6 Packaging, Transport and Storage ... 8
Foreword
This Standard was drafted in accordance with the rules specified in GB/T 1.1-2009.
Please note that some contents in this Document may involve patents. The issuing organization of this
Document does not undertake the responsibility to identify these patents.
This Standard was proposed by State Food and Drug Administration.
This Standard shall be under the jurisdiction of the China Clinical Laboratory Testing and In vitro
Diagnostic Test System of Standardization Administration of China (SAC/TC 136).
Drafting organization of this Standard. National Institute for Food and Drug Control.
The main drafters of this Standard. Wang Yumei, Liu Yan, Wang Yumei, Gao Shangxian, and Zhang
Chuntao.
Total bilirubin test kit (Vanadate oxidation method)
1 Scope
This standard specifies the determination principle, requirements, test method, signs, instructions,
packaging, transport and storage of total bilirubin test kit (Vanadate oxidation method).
This standard applies to the quality control of total bilirubin test kit (Vanadate oxidation method).
2 Normative References
The following document is indispensable for the application of this document. For dated references,
only dated edition applies to this document. For undated references, the latest edition (including all
amendments) applies to this document.
YY/T 0466.1 Medical Devices. Symbols to Be Used with Medical Device Labels, Labeling and
Information to Be Supplied. Part 1. General Requirements
3 Requirements
3.1 Appearance
It shall meet the appearance requirements specified the manufacturer.
3.2 Installed capacity
The installed capacity of liquid reagent shall not be less than the labeled amount.
3.3 Absorbance of reagent blank
The absorbance of reagent blank shall not be less than 0.050 at the wavelength of 450 nm.
3.4 Linear interval
The linear correlation coefficient (r) shall not be less than 0.9900 within the linear interval
specified by the manufacturer.
3.5 Accuracy
Use the traceable standard material to carry out the determination. The deviation between measured
value and indicated value shall be within ±10.0%.
3.6 Analysis sensitivity
The test kit shall be transported according to the requirements of the manufacturer, and shall be free
of moisture, stress, sunshine, rain, snow, acid, alkaline and damage of exterior and interior packaging
during the transport.
6.3 Storage
Test kit shall be stored under the conditions specified by the manufacturer.
......
| Standard ID | YY/T 1205-2013 (YY/T1205-2013) | | Description (Translated English) | Total bilirubin test kit (Vanadate oxidation method) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 8,886 | | Quoted Standard | YY/T 0466.1 | | Drafting Organization | Chinese Academy of Food and Drug Testing | | Administrative Organization | National Medical clinical testing laboratories and in vitro diagnostic systems for Standardization Technical Committee | | Regulation (derived from) | State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies: total bilirubin assay kit (vanadate oxidation method) requirements, test methods, marking, labeling and instructions for use, packaging, transportation and storage. This standard applies to: total bilirubin assay kit (vanadate oxi |
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