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YY/T 1206-2013 (YYT 1206-2013)

YY/T 1206-2013_English: PDF (YYT1206-2013)
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YY/T 1206-2013English145 Add to Cart 0--3 minutes. Auto-delivered. Total cholesterol kit (COD-PAP method) YY/T 1206-2013 Valid YY/T 1206-2013

BASIC DATA
Standard ID YY/T 1206-2013 (YY/T1206-2013)
Description (Translated English) Total cholesterol kit (COD-PAP method)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 8,826
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 cholesterol assay kit (oxidase) Technical requirements, including terminology and definitions, classification and nomenclature, requirements, test methods, labeling, instructions for use, packaging, transportation and storag

YY/T  1206‐2013 
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S 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.