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

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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

Basic Data

Standard ID	YY/T 1206-2013 (YY/T1206-2013)
Description (Translated English)	Total cholesterol kit (COD-PAP method)
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	8,869
Quoted Standard	YY/T 0466.1
Regulation (derived from)	State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
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