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YY/T 1206-2013 English PDF (YYT1206-2013)

YY/T 1206-2013 English PDF (YYT1206-2013)

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YY/T 1206-2013: Total cholesterol kit (COD-PAP method)

This standard specifies the determination principle, requirements, test method, marks, instructions, packaging, transport and storage, etc. of total cholesterol kit (COD-PAP method). This standard applies to the quality control of liquid-type total cholesterol kit (COD-PAP method) of single reagent and double reagent used for quantitative inspection in medical laboratory.
YY/T ??1206?€?2013
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
YYY/T 1206-2013
Total cholesterol kit (COD-PAP method)
Issued by. State China 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 Requirement ... 4
4 Test Method ... 5
5 Mark, Label and Instructions ... 7
6 Packaging, Transport and Storage ... 9
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. Liu Yan, Sun Nan, Wang Yumei, Zhang Chuntao, and Gao Shangxian.
Total cholesterol kit (COD-PAP method)
1 Scope
This standard specifies the determination principle, requirements, test method, marks, instructions, packaging, transport and storage, etc. of total cholesterol kit (COD-PAP method).
This standard applies to the quality control of liquid-type total cholesterol kit (COD-PAP method) of single reagent and double reagent used for quantitative inspection in medical laboratory.
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 Requirement
3.1 Appearance
It shall meet the normal appearance requirements specified by 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
At the wavelength of 500nm~550nm, for double-reagent kits, it shall not be greater than 0.080; for single-reagent kits, it shall not be greater than 0.100. 3.4 Linear interval
The linear correlation coefficient (r) of theoretical concentration and measured concentration shall not be less than 0.990, within the linear interval specified by the manufacturer.
3.5 Accuracy
6 Packaging,??Transport??and??Storage
6.1 Packaging
The packaging-pictorial marking for handling of goods shall meet the requirements of YY/T 0466.1. The packaging container shall be sealed well, intact, and free of leakage and damage.
6.2 Transport
The 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.

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