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YY/T 1218-2013 (YYT 1218-2013)

YY/T 1218-2013_English: PDF (YYT1218-2013)
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YY/T 1218-2013English145 Add to Cart 0--3 minutes. Auto-delivered. Thyroid-stimulating hormone quantitative labelling immunoassay kit YY/T 1218-2013 Valid YY/T 1218-2013

BASIC DATA
Standard ID YY/T 1218-2013 (YY/T1218-2013)
Description (Translated English) Thyroid-stimulating hormone quantitative labelling immunoassay kit
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 9,993
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 announcement 2013 No. 36; 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 the thyrotropin labeled immunosorbent assay kit for quantitative classification, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage. This standard applies to the principle of the quan

YY/T 1218-2013
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Thyroid-stimulating hormone quantitative
labelling immunoassay kit
ISSUED ON. OCTOBER 21, 2013
IMPLEMENTED ON. OCTOBER 1, 2014
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3 
1  Scope ... 4 
2  Normative references ... 4 
3  Classifications ... 4 
4  Requirements ... 5 
5  Test methods ... 6 
6  Identifications, labels and instructions ... 8 
7  Packaging, transportation and storage ... 10 
Bibliography ... 11 
Foreword 
This Standard is drafted according to the rules specified in GB/T 1.1-2009.
Please note that some contents in this Standard may involve patents. The issuing
authority of this Standard does not undertake the responsibility to identify these patents.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee (SAC/TC
136) on System of Medical Clinical Test Lab and in Vitro Diagnostic System of
Standardization Administration of China.
Drafting organization of this Standard. National Institutes for Food and Drug Control.
The main drafters of this Standard. Huang Ying, Li Lili, Yu Ting, and Gao Shangxian.
Thyroid-stimulating hormone quantitative labelling
immunoassay kit
1  Scope 
This Standard specifies the classification, requirements, test methods, marks, labels,
instructions, packaging, transportation, and storage of the thyroid-stimulating hormone
quantitative labelling immunoassay kit.
This Standard is applicable to the quantitative determination of thyroid-stimulating
hormone (TSH) kit (hereinafter referred to as “TSH kit”) based on the principle of double
antibody sandwich method. It includes the immunoassay kit for quantitative determination
of TSH by using labelling methods such as enzyme labelling, (electrical)
chemiluminescent labelling, and (time resolution) fluorescence labelling AS capture
antibody; and taking microplates, pipes, magnetic particles, microbeads and plastic beads
etc. AS the carrier coated antibody.
This Standard does not apply to.
a) Colloidal gold labelled TSH test strip;
b) Various types of radio-immunity or IRMA kit labelled with 125I and other radioactive
isotopes.
2  Normative references 
The articles contained in the following documents have become part of this Document
when they are quoted herein. For the dated documents so quoted, all the modifications
(Including all corrections) or revisions made thereafter shall be applicable to this
document.
YY/T 0466.1-2009 Medical devices -- Symbols to be used with medical device labels,
labelling and information to be supplied -- Part 1. General requirements
3  Classifications 
According to different labelling methods, TSH kit can be divided into the enzyme-labelled
TSH kit, (electrical) chemiluminescent labelled TSH kit, (time resolution) fluorescence
labelled TSH kit and the like. According to the solid carrier, it can be divided into TSH kits
with carriers of microplates, pipes, magnetic particles, microbeads, and plastic beads etc.
Two or three quality control products are set up in different areas of dose-response curves.
The coefficient of variation (CV) of measured value of quality control products shall comply
with the provision of 4.5.2, among not-less-than 3-times independent analysis. The
calculation method is the same as 5.5.1.
Note. “Among Independent analysis” include. Among different independent experiments, among different
time periods within the validity of the kit, among different experiments with the same operator, and among
different operators, etc.
5.5.3 Precision between-batches
Two or three quality control products are set up in different areas of dose-response curves.
The coefficient of variation (CV) of measured value of quality control products shall comply
with the provision of 4.5.2, among at least 3 batches of products for independent analysis.
The calculation method is the same as 5.5.1.
5.6 Measured value of quality control products
Two or three quality control products are set up in different areas of dose-response curves.
The measured results of the kit shall comply with the provision of 4.6.
5.7 Specificity
The sample with specificity shall be prepared to a prescribed concentration by using the
kit buffer system. The measured results of the kit shall comply with the provisions of 4.7.1,
4.7.2 and 4.7.3.
5.8 Stability
After the kit is preserved according to the provisions of 4.8.1 or 4.8.2, the inspection
results shall comply with the provisions of 4.1, 4.2, 4.3, 4.4, 4.5.1, 4.5.2 and 4.6.
6  Identifications, labels and instructions 
6.1 The identifications and labels of the kit’s external packaging boxes shall comply with
the provision of YY/T 0466.1, and at least contain the following contents.
a) Product name and specification;
b) Name, address and contact information of manufacturers;
c) Medical device registration certificate number and product standard number;
d) Product batch number;
e) Period of validity;
Bibliography 
[1] GB/T 3358.1 Statistical terms - Part 1. General statistical terms and terms used in
probability
[2] JJF 1001-2011 General Terms in Metrology and Their Definitions
[3] Ye Yingwu. National Guide to Clinical Laboratory Procedures Third Edition Nanjing.
Southeast University Press, 2006
[4] YY/T 0316-2008 Medical Devices - application of risk management to medical
devices
[5] State Pharmacopoeia Commission. General principles of the radiation immunoassay
kit, 2005
[6] State Pharmacopoeia Commission. Requirements for China Biological Products (2000
Edition)
[7] Guo Zuchao. Medical mathematical statistical method; Third Edition; Beijing. People’s
Medical Publishing House, 1988