YY/T 1214-2019_English: PDF (YY/T1214-2019)
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Human chorionic gonadotrophin detection kit
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YY/T 1214-2019
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| YY/T 1214-2013 | English | 160 |
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Human chorionic gonadotrophin quantitative labelling immunoassay kit
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YY/T 1214-2013
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| Standard ID | YY/T 1214-2019 (YY/T1214-2019) | | Description (Translated English) | Human chorionic gonadotrophin detection kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 10,130 | | Date of Issue | 2019 | | Date of Implementation | 2020-08-01 | | Summary | This standard specifies the classification, requirements, test methods, labels and instructions for use, packaging, transportation and storage of human chorionic gonadotropin assay kits. This standard applies to kits for quantitative determination of human chorionic gonadotropin based on the double-antibody sandwich method, including immunoassay kits using enzyme labeling, (electro)chemiluminescence labeling, (time-resolved) fluorescent labeling and other labeling methods. This standard does not apply to reagents (such as test strips, etc.) for the semi-quantitative determination of human chorionic gonadotropin labeled with colloidal gold or other methods; or immunoradiation kits. This standard replaces YY/T 1214-2013 "Human Chorionic Gonadotropin Quantitative Labeling Immunoassay Kit". | | Standard ID | YY/T 1214-2013 (YY/T1214-2013) | | Description (Translated English) | Human chorionic gonadotrophin 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 | 9,920 | | 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: a quantitative marker of human chorionic gonadotropin immunoassay kit classification, requirements, test methods, marking, labeling and instructions for use, packaging, transportation and storage. This standard applies to: the pri |
YY/T 1214-2019
Human chorionic gonadotrophin detection kit
ICS 11.040.30
C30
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 1214-2013
Human chorionic gonadotropin assay kit
Published on.2019-07-24
2020-08-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 1214-2013 "Human chorionic gonadotropin quantitative labeling immunoassay kit", and YY/T 1214-
Compared with.2013, the main changes are as follows.
--- Increased the method of calculating the relative deviation in the accuracy experiment;
--- Eliminated the precision within the analysis and the inter-analytical precision items, and merged into the intra-batch precision;
--- Cancel the measurement item of the quality control item.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This standard was drafted. China Food and Drug Control Institute, Roche Diagnostics (Shanghai) Co., Ltd., Siemens medical diagnostic products
(Shanghai) Co., Ltd., Abbott Trading (Shanghai) Co., Ltd.
The main drafters of this standard. Yu Ting, Huang Ying, Qu Shoufang, Sun Nan, Huang Jie, Cai Xiaorong, Ge Yawen, Wang Shaoying, Xiao Wei, Wang Xuefeng, Zhang Hong.
Human chorionic gonadotropin assay kit
1 Scope
This standard specifies the classification, requirements, test methods, labels and instructions for use of human chorionic gonadotropin determination kits, packaging,
Transportation, storage.
This standard applies to the kit for the quantitative determination of human chorionic gonadotropin by the double antibody sandwich method, including enzyme labeling, (electric)
Immunoassay kit for labeling methods such as chemiluminescent labeling, (time-resolved) fluorescent labeling.
This standard does not apply. semi-quantitative determination of human chorionic gonadotropin reagents by colloidal gold or other methods (eg, test strips)
Etc.); a variety of human chorionic gonadotropin radioimmunoassay or immunoradiometric kits labeled with a radioisotope such as 125I.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents
3 classification
According to different labeling methods, it can be divided into enzyme label, (electro) chemiluminescent label, (time-resolved) fluorescent label, etc.
The same can be divided into microplate type, tube type, magnetic particles, microspheres and plastic beads; can be divided into manual operation methods and instruments according to different operating procedures
Automatic operation method.
4 requirements
4.1 Appearance
Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of their products. Generally, there should be components and traits of each component of the kit; internal and external
Requirements for packaging, labeling, etc.
4.2 Detection limit
Should not be higher than 5.0 IU/L.
4.3 Linear
Within the linear range given by the manufacturer (the lower limit should not be higher than 5.0 IU/L, and the upper limit should be no less than 1000 IU/L; enzyme-linked immunosorbent assay
The upper limit of the kit should be no less than.200 IU/L), and the correlation coefficient (r) should be no less than 0.9900.
4.4 Accuracy
Accuracy should meet one of the following requirements.
a) Detection of human chorionic gonadotropin national (or international) standards within the linear range specified in the kit, relative to the results of the assay
YY/T 1214-2019
Human chorionic gonadotrophin detection kit
ICS 11.040.30
C30
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 1214-2013
Human chorionic gonadotropin assay kit
Published on.2019-07-24
2020-08-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 1214-2013 "Human chorionic gonadotropin quantitative labeling immunoassay kit", and YY/T 1214-
Compared with.2013, the main changes are as follows.
--- Increased the method of calculating the relative deviation in the accuracy experiment;
--- Eliminated the precision within the analysis and the inter-analytical precision items, and merged into the intra-batch precision;
--- Cancel the measurement item of the quality control item.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This standard was drafted. China Food and Drug Control Institute, Roche Diagnostics (Shanghai) Co., Ltd., Siemens medical diagnostic products
(Shanghai) Co., Ltd., Abbott Trading (Shanghai) Co., Ltd.
The main drafters of this standard. Yu Ting, Huang Ying, Qu Shoufang, Sun Nan, Huang Jie, Cai Xiaorong, Ge Yawen, Wang Shaoying, Xiao Wei, Wang Xuefeng, Zhang Hong.
Human chorionic gonadotropin assay kit
1 Scope
This standard specifies the classification, requirements, test methods, labels and instructions for use of human chorionic gonadotropin determination kits, packaging,
Transportation, storage.
This standard applies to the kit for the quantitative determination of human chorionic gonadotropin by the double antibody sandwich method, including enzyme labeling, (electric)
Immunoassay kit for labeling methods such as chemiluminescent labeling, (time-resolved) fluorescent labeling.
This standard does not apply. semi-quantitative determination of human chorionic gonadotropin reagents by colloidal gold or other methods (eg, test strips)
Etc.); a variety of human chorionic gonadotropin radioimmunoassay or immunoradiometric kits labeled with a radioisotope such as 125I.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents
3 classification
According to different labeling methods, it can be divided into enzyme label, (electro) chemiluminescent label, (time-resolved) fluorescent label, etc.
The same can be divided into microplate type, tube type, magnetic particles, microspheres and plastic beads; can be divided into manual operation methods and instruments according to different operating procedures
Automatic operation method.
4 requirements
4.1 Appearance
Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of their products. Generally, there should be components and traits of each component of the kit; internal and external
Requirements for packaging, labeling, etc.
4.2 Detection limit
Should not be higher than 5.0 IU/L.
4.3 Linear
Within the linear range given by the manufacturer (the lower limit should not be higher than 5.0 IU/L, and the upper limit should be no less than 1000 IU/L; enzyme-linked immunosorbent assay
The upper limit of the kit should be no less than.200 IU/L), and the correlation coefficient (r) should be no less than 0.9900.
4.4 Accuracy
Accuracy should meet one of the following requirements.
a) Detection of human chorionic gonadotropin national (or international) standards within the linear range specified in the kit, relative to the results of the assay
......
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
......
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