YY/T 1213-2019 (YY/T1213-2019, YYT 1213-2019, YYT1213-2019) & related versions
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| YY/T 1213-2019 | English | 199 |
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Follicle stimulating hormone testing kit
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YY/T 1213-2019
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YYT 1213-2019
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| YY/T 1213-2013 | English | 170 |
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Follicle stimulating hormone quantitative labelling immunoassay kit
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YY/T 1213-2019: PDF in English (YYT 1213-2019)
YY/T 1213-2019
Follicle stimulating hormone testing kit
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 1213-2013
Follicle stimulating hormone assay kit
Foliclestimulatinghormonetestingkit
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 Category 1
4 Requirements 1
5 Test method 2
6 Labels and instruction manual 4
7 Packaging, transportation, storage 4
Reference 5
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 1213-2013. In addition to editorial changes, major technical changes compared to YY/T 1213-2013
as follows.
--- Modified the standard name;
--- Added information on the GB/T 29791.2 in vitro diagnostic medical device manufacturer (marked) in the normative reference document
Part 2. Professional in vitro diagnostic reagents, delete GB 9969-1998, YY 0466-2003 and GB/T 21415-
2008/ISO 17511.2003 (see 2);
--- Revised the requirements for detection limits and the corresponding detection methods (see 4.2 and 5.2);
---Modified linear requirements and corresponding detection methods (see 4.3 and 5.3);
--- Revised the accuracy requirements and corresponding detection methods (see 4.4 and 5.4);
--- Removed the precision within the analysis and the precision between the analysis, combined into the intra-assay precision (see 4.5.1);
--- Revised the requirements for specificity (see 4.6);
--- Deleted the measurement value item of the quality control item;
---Modified the label and the instructions for use (see Chapter 6).
--- Increased packaging should comply with the provisions of GB/T 191 (see 7.1).
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 Research Institute, Beijing Medical Device Inspection Institute, Roche Diagnostics Products (Shanghai) Co., Ltd.
Division, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd., Abbott Trade (Shanghai) Co., Ltd., Orson Multi Devices Trading (China) Co., Ltd.
Boao Bio Group Co., Ltd.
The main drafters of this standard. Huang Ying, Yu Ting, Qu Shoufang, Sun Nan, Huang Jie, Wang Ruixia, Cai Xiaorong, Ge Yawen, Wang Shaoying, Xiao Wei, Wang Xuefeng,
Wu Xiaojun, Shi Weihong, Guo Jianfu.
This standard replaces YY/T 1213-2013.
Follicle stimulating hormone assay kit
1 Scope
This standard specifies the classification, requirements, test methods, labels and instructions for use of the follicle stimulating hormone assay kit, packaging, transportation,
Storage.
This standard applies to the kit for quantitative determination of follicle stimulating hormone by the double antibody sandwich method, including enzyme labeling, (electro) chemical
An immunoassay kit for labeling methods such as photo-marking, (time-resolved) fluorescent labeling.
This standard does not apply to semi-quantitative determination of follicle stimulating hormone reagents (eg, test strips, etc.) by colloidal gold or other methods;
A variety of follicle stimulating hormone 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 2.0 IU/L.
4.3 Linear
Within the linear range given by the manufacturer (the lower limit should not be higher than 2.0 IU/L, the upper limit should be no less than 100 IU/L), and the correlation coefficient (r) should not
Below 0.9900.
4.4 Accuracy
Accuracy should meet one of the following requirements.
a) In the linear range specified by the kit, the follicle stimulating hormone national (or international) standard is tested, and the relative deviation of the determination results should be
YY/T 1213-2019
Follicle stimulating hormone testing kit
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 1213-2013
Follicle stimulating hormone assay kit
Foliclestimulatinghormonetestingkit
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 Category 1
4 Requirements 1
5 Test method 2
6 Labels and instruction manual 4
7 Packaging, transportation, storage 4
Reference 5
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 1213-2013. In addition to editorial changes, major technical changes compared to YY/T 1213-2013
as follows.
--- Modified the standard name;
--- Added information on the GB/T 29791.2 in vitro diagnostic medical device manufacturer (marked) in the normative reference document
Part 2. Professional in vitro diagnostic reagents, delete GB 9969-1998, YY 0466-2003 and GB/T 21415-
2008/ISO 17511.2003 (see 2);
--- Revised the requirements for detection limits and the corresponding detection methods (see 4.2 and 5.2);
---Modified linear requirements and corresponding detection methods (see 4.3 and 5.3);
--- Revised the accuracy requirements and corresponding detection methods (see 4.4 and 5.4);
--- Removed the precision within the analysis and the precision between the analysis, combined into the intra-assay precision (see 4.5.1);
--- Revised the requirements for specificity (see 4.6);
--- Deleted the measurement value item of the quality control item;
---Modified the label and the instructions for use (see Chapter 6).
--- Increased packaging should comply with the provisions of GB/T 191 (see 7.1).
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 Research Institute, Beijing Medical Device Inspection Institute, Roche Diagnostics Products (Shanghai) Co., Ltd.
Division, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd., Abbott Trade (Shanghai) Co., Ltd., Orson Multi Devices Trading (China) Co., Ltd.
Boao Bio Group Co., Ltd.
The main drafters of this standard. Huang Ying, Yu Ting, Qu Shoufang, Sun Nan, Huang Jie, Wang Ruixia, Cai Xiaorong, Ge Yawen, Wang Shaoying, Xiao Wei, Wang Xuefeng,
Wu Xiaojun, Shi Weihong, Guo Jianfu.
This standard replaces YY/T 1213-2013.
Follicle stimulating hormone assay kit
1 Scope
This standard specifies the classification, requirements, test methods, labels and instructions for use of the follicle stimulating hormone assay kit, packaging, transportation,
Storage.
This standard applies to the kit for quantitative determination of follicle stimulating hormone by the double antibody sandwich method, including enzyme labeling, (electro) chemical
An immunoassay kit for labeling methods such as photo-marking, (time-resolved) fluorescent labeling.
This standard does not apply to semi-quantitative determination of follicle stimulating hormone reagents (eg, test strips, etc.) by colloidal gold or other methods;
A variety of follicle stimulating hormone 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 2.0 IU/L.
4.3 Linear
Within the linear range given by the manufacturer (the lower limit should not be higher than 2.0 IU/L, the upper limit should be no less than 100 IU/L), and the correlation coefficient (r) should not
Below 0.9900.
4.4 Accuracy
Accuracy should meet one of the following requirements.
a) In the linear range specified by the kit, the follicle stimulating hormone national (or international) standard is tested, and the relative deviation of the determination results should be
......
| Standard ID | YY/T 1213-2019 (YY/T1213-2019) | | Description (Translated English) | Follicle stimulating hormone testing kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 10,172 | | Date of Issue | 2019 | | Date of Implementation | 2020-06-01 | | Summary | This standard specifies the classification, requirements, test methods, labels and instructions for use, packaging, transportation and storage of follicle stimulating hormone assay kits. This standard applies to kits for quantitative determination of follicle-stimulating hormone based on the principle of 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 for semi-quantitative determination of follicle-stimulating hormone (such as test strips, etc.) labeled with colloidal gold or other methods; Reagent test kit. |
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