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YY/T 1213-2019 English PDF (YY/T 1213-2013)

YY/T 1213-2019_English: PDF (YY/T1213-2019)
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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
YY/T 1213-2013English170 Add to Cart 0--9 seconds. Auto-delivery Follicle stimulating hormone quantitative labelling immunoassay kit Obsolete YY/T 1213-2013


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.

BASIC DATA
Standard ID YY/T 1213-2013 (YY/T1213-2013)
Description (Translated English) Follicle 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 9,988
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: FSH quantitative labeled immunoassay kit classification, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage. This standard applies to: Principle quantitative determination of follicl


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 ......


YY/T 1213-2013  YY ICS 11.100 C 44 INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA Follicle stimulating hormone quantitative labelling immunoassay kit ISSUED ON. DECEMBER 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  Classification ... 4  4  Requirements ... 5  5  Test methods ... 6  6  Marks, labels and instructions ... 8  7  Packaging, transportation and storage ... 10  Bibliography ... 11  Foreword  This standard was drafted in accordance with the rules specified in GB/T 1.1-2009. Please note that some contents in this file may involve patents. The issuing organization of this file does not bear the responsibility to identify these patents. This standard was proposed by the China Food and Drug Administration. This standard shall be under the jurisdiction of China Clinical Laboratory Testing and In vitro Diagnostic Test System of Standardization Administration of China (SAC/TC 136). Drafting organization of this standard. National Institutes for Food and Drug Control. The main drafters of this standard. Huang Ying, Shen Shu, Yu Ting, Zhang Chuntao, and Gao Shangxian. Follicle stimulating hormone quantitative labelling immunoassay kit 1  Scope  This standard specifies the classification, requirements, test method, marks, labels, instructions, packaging, transportation and storage etc. of the follicle stimulating hormone quantitative labelling immunoassay kit. This standard is applicable to follicle stimulating hormone (FSH) kit [herein after referred to as “FSH kit”] that is quantitatively determined and based on the principle of double antibody sandwich method. It includes the FSH immunoassay kit of quantitative determination by using enzyme labelling, (electrical) chemiluminescent labelling, (time resolution) fluorescence labelling and other labelling methods as the capture antibodies; and taking micro-plates, tubes, magnetic particles, micro-beads and plastic beads and others as the carrier coated antibodies. This standard does not apply to. a) Colloidal gold labeled FSH test strip; b) Various types of FSH radio-immunity or IRMA kit labeled 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 Devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1. General requirements 3  Classification  The FSH kits can be classified into enzyme labelling FSH kit, (electrical) chemiluminescent labelling FSH kit, (time resolution) fluorescence labelling FSH kit etc., according to the various labelling methods. It can also be divided into different kinds of FSH kits taking micro-plates, pipes, magnetic particles, micro-beads and plastic beads as carrier, according to the various solid phase carriers. It can be divided into manual CV — Coefficient of variation. 5.5.2 Analytical within-precision 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 be in accordance with the provisions of 4.5.2 among independent analysis with no less than 3 times. The calculation method is same as 5.5.1. Note. Independent analyses includes. Among different independent experiments, among different time periods within the period of validity of the kit, among different laboratories with the same kit and among different operators, etc. 5.5.3 Within-batch precision 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 be in accordance with the provisions of Clause 4.5.2 among at least 3 batches of products. The calculation method is same as 5.5.1. 5.6 The 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 be in accordance with the provisions of Clause 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 be in accordance 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 Clause 4.8.1 or 4.8.2, the measured results shall be in accordance with related provisions of Clause 4.1, 4.2, 4.3, 4.4, 4.5.1, 4.5.2 and 4.6. 6  Marks, labels and instructions  6.1 Outer package of kit It shall be in compliance with the requirements of YY/T0466.1, and at least contains the following content. a) Product name, specification; b) Name, address and contact information of manufacturers; m) Product performance index; n) Precautions; o) References; p) Manufacturing enterprise; q) License number of medical device manufacturers (limited to domestic enterprises); r) Medical Device Registration Certificate Number; s) Product standard number; t) Approval and modified date of instructions. 7  Packaging, transportation and storage  7.1 Package Intact, free of leakage and damage. 7.2 Transportation The transportation of the kit shall be in compliance with the requirement of the manufacturer. 7.3 Storage The kit shall be kept under the conditions specified by the manufacturer. Bibliography  1. GB/T 3358.1 Statistics — Vocabulary and symbols — 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 clinical laboratory operation specification. Edition 3. Nanjing. Southeast Press, 2006 4. YY/T 0316-2008 Medical devices — Application of risk management to medical devices (ISO 14971. 2007, IDT) 5. Chinese Pharmacopoeia Commission. General principles of Radioimmunoassay Kit. 6. Chinese Pharmacopoeia Commission. Chinese Requirements for Biological Products (2000) 7. Guo Zuchao. Statistical Methods for Medical Use, Edition 3. Beijing. People Health Press, 1988 ......

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