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YY/T 1213-2019 English PDF

YY/T 1213-2019 (YY/T1213-2019, YYT 1213-2019, YYT1213-2019)
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YY/T 1213-2019English199 Add to Cart 3 days [Need to translate] Follicle stimulating hormone testing kit Valid YY/T 1213-2019
Standards related to: YY/T 1213-2019

BASIC DATA
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.

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 ...