YY/T 1214-2013 English PDF (YYT1214-2013)

This Standard specifies the classification, requirements, test method, marks, labels, operating instructions, packaging, transportation, and storage of the human chorionic gonadotrophin quantitative labelling immunoassay kit.

YY/T 1214-2013
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Human chorionic gonadotrophin 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 ... 7
6 Marks, labels and instructions ... 9
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 of this Standard may involve patents. The issuing authority of this Standard does not undertake the responsibility of identifying these patents.
The Standard was proposed by China Food and Drug Administration.
The Standard shall be under the jurisdiction of National Technical Committee 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, Shen Shu, Zhang Chuntao, Yu Ting, and Gao Shangxian.
Human chorionic gonadotrophin quantitative labelling
immunoassay kit
1 Scope
This Standard specifies the classification, requirements, test method, marks, labels, operating instructions, packaging, transportation, and storage of the human chorionic gonadotrophin quantitative labelling immunoassay kit.
This Standard is applicable to the quantitative detection of human chorionic gonadotrophin (HCG) quantitative labelling immunoassay kit [herein after referred to as “HCG reagent (kit)”] that is based on the principle of double antibody sandwich method. It includes the HCG immunoassay kit for quantitative detection by using labelling methods such as enzyme labelling, (electrical) chemiluminescent labelling, (time resolution) fluorescence AS capture antibody; and using microplates, pipes, magnetic particles, microbeads and plastic beads and others AS the carrier coated antibody.
The Standard does not apply to.
a) Colloidal gold labelled HCG test strip;
b) Various types of HCG radio-immunity or IRMA reagent 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
The HCG reagent kit can be classified into enzyme labelling HCG reagent kit, (electrical) chemiluminescent labelling HCG reagent kit, (time resolution) fluorescence labelling HCG reagent kit etc., according to the various labelling methods. It can also be divided into different kinds of HCG reagent with carriers microplates, pipes, magnetic particles, 6 Marks, labels and instructions
6.1 Outer package of reagent (kit)
The marks and labels of the kit’s outer packaging box shall comply with the provisions of YY/T 0466.1, and at least contain the following contents.
a) Product name and specifications;
b) Name, address and contact information of manufacturing enterprise;
c) Medical device registration certificate number and product standard number; d) Product batch number;
e) Period of validity;
f) Storage conditions.
6.2 Label of each component of reagent (kit)
It shall contain at least the following contents.
a) Product name and specifications;
b) Name or marks of manufacturing enterprise;
c) Product batch number;
d) Period of validity;
e) Storage conditions.
6.3 Operating instructions of reagent (kit)
It shall generally contain the following contents.
a) Product name;
b) Packaging specifications;
c) Intended use;
d) Inspection principle;
e) Main compositions;
f) Storage conditions and period of validity;
Bibliography
[1] GB/T 3358.1 Statistical terminology - 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