HOME   Cart(0)   Quotation   About-Us Tax PDFs Standard-List Powered by Google www.ChineseStandard.net Database: 189759 (29 Sep 2024)

YY/T 1240-2023 related PDF English

YY/T 1240-2023 (YY/T1240-2023, YYT 1240-2023, YYT1240-2023) & related versions
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)See DetailStatusSimilar PDF
YY/T 1240-2023English279 Add to Cart 3 days (D-dimer assay kit (immunoturbidimetric method)) YY/T 1240-2023 Valid YYT 1240-2023
YY/T 1240-2014English160 Add to Cart 0-9 seconds. Auto delivery. D-Dimer reagent (kit) YY/T 1240-2014 Obsolete YYT 1240-2014



YY/T 1240-2023: PDF in English (YYT 1240-2023)
YY/T  1240‐2014  YY ICS 11.100 C 44 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA D-Dimer reagent (kit) ISSUED ON. JUNE 17, 2014 IMPLEMENTED ON. JULY 1, 2015 Issued by. State Food and Drug Administration Table of Contents Foreword ... 3  1  Scope ... 4  2  Normative references ... 4  3  Terms and definitions ... 4  4  Requirements ... 5  5  Test methods ... 6  6  Marks, labels and instructions ... 8  7  Packaging, transportation and storage ... 10  Annex A (Informative) The application of patient assessment and pre-test probability ... 12  Annex B (Informative) Applicable instructions about D-Dimer ... 13  Bibliography ... 15  Foreword  This Standard is drafted according to the rules specified in GB/T 1.1-2009. Please note that some contents of this Document may involve patents. The issuing authority of this Document does not undertake the responsibility of identifying these patents. The Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of National Technical Committee (SAC/TC 136) on System of Medical Clinical Test Lab and in Vitro Diagnostic System of Standardization Administration of China. Drafting organizations of this Standard. People’s Liberation Army General Hospital, Beijing Institute of Medical Device Testing, Beijing Success Technology Development Co., Ltd, and Werfen Medical Device International Trading (Shanghai) Co., Ltd. The main drafters of this Standard. Li Jian, Bi Chunlei, Ding Chonghui, and Yu Hui. D-Dimer reagent (kit) 1  Scope  This Standard specifies the term and definition, requirements, test methods, symbols, labels and instructions, packing, transportation, and storage of D-Dimer quantitative detection reagent (kit). This Standard applies to immunoturbidimetric D-Dimer reagent (kit) (hereinafter referred to as D-D reagent) used in laboratory. 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. GB/T 191 Packaging - Pictorial marking for handling of goods GB 3100 The international system of units and its application GB 3101 General principles concerning quantities, units and symbols GB 3102 (All parts) Quantities and Units 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  Terms and definitions  For the purpose of this Document, the following terms and definitions apply. 3.1 immunoturbidimetric D-dimer assay The homogeneous latex particles, coated by monoclonal antibody, COMBINE with the degradation product’s specificity of the soluble fibrin of D-D antigen determinants in plasma. So that it makes the latex particles to coagulate each other. The coagulation degree is proportional to the concentration of D-Dimer in the specimen. At certain 5.7 Report pattern VERIFY the reporting template. It shall meet the requirements specified in 4.6. 6  Marks, labels and instructions  6.1 General requirements The general requirements of symbols, labels and instructions are as follows. a) The form and content of the labels and instructions shall adapt to the expected uses of the reagent (kit); b) Use the symbols specified in YY/T 0466.1. If there is no relevant standard or users fail to understand the symbols used, those symbols and colors shall be explained in the instructions; c) The numerical unit provided shall be understood by users. Use the symbols specified in GB3100-3102; d) The microbiological status of the product shall be explained when using the product; e) Unless it is easy to know how to use the reagent (kit), there shall have instructions. — There shall have relevant instructions or symbols to prompt users to carefully read the instructions before using the reagent (kit); — The language used in the instructions shall be understood by the expected users; f) Emphasize and prompt users the important changes of the reagent (kit) and the position of the relevant information; g) Warn users the possible risks and dangers by words or symbols; h) The name, letter, number, symbol, color and graph of each component of the reagent (kit) shall be marked in the same way; i) The reagent instructions can be put in the packing as separated pages, which can be on the external surface of the container, in the manual, in the operation manual, or integrated with the instructions of the instruments or analyzing system. j) The reagent instructions can be in electronic version. k) Some of the instructions can be provided in a coded form, and be explained in the system operation manual; l) If there is no detailed instructions attached to the reagent (kit), the manufacturing enterprise shall make sure that users can get a correct version of the reagent (kit) instructions; m) The labels of the exterior packing and initial packing shall include the required information, which shall be described by intelligible words or symbols; Examples. The quality, font and font size of the printing; n) The labels and instructions provided with the reagent (kit) shall include how to handle and store the reagent before using. 6.2 Labels for outer packing The label in the exterior packing shall provide the following information. a) Reagent name; b) Packaging specifications; c) IVD reagents; d) Storage conditions; e) Batch number; f) Valid period; g) Registration certificate number; h) Product standard number; i) Name and address of manufacturing enterprise. 6.3 Labels for inner packing The label in the interior packing shall provide the following information. a) Reagent name; b) Packaging specifications; c) Storage conditions; d) Batch number; e) Valid period; f) Name of the manufacturing enterprise. 6.4 Operating instructions B.2.3.3 When performing clinical assessment, the tested reagent shall be compared with another D-dimer reagent system that has been confirmed by authentic institution and possesses the VTE diagnosing function. B.2.3.4 Negative predictive value (NPV) is 97% and above (lower limit of 95% confidence interval is not lower than 95%). The auxiliary diagnosis has no specific requirement to sensitivity. B.2.4 Used for the exclusion diagnosis of VTE B.2.4.1 Characteristics. The clinical doctor excludes the VTE through D-dimer experiment, combining PTP. B.2.4.2 The VTE-suspected patients are continuously selected in clinical research. It shall be performed at 3 centers at least. The 3 centers use the same PTP principle. The sample size possesses the statistical significance (Both incidences of DVT and PE >10%). B.2.4.3 The clinical assessment takes the imaging diagnosis result (clinical fact) as the criterion. If the imaging diagnosis does not confirm VTE, then the patient will be traced for 3 months to confirm the negative result. B.2.4.4 Negative predictive value (NPV) is 97% and above (lower limit of 95% confidence interval is not lower than 95%). The sensibility is not lower than 95% (the lower level of 95% confidence interval is not lower than 90%). Bibliography 1) Huang Yueqin. Clinical Epidemiology. Beijing. People's Medical Publishing House, 2) Jack Hirsh, Agnes Y. Y. Lee. How we diagnose and treat deep vein thrombosis. Blood, 2002. 99. 3102-3110 3) Wells, P.s.., D.R. Anderson, et al. Evaluation of D-dimer in the diagnosis of suspected deep-vein thrombosis. N Engl J Med. 2003; 349 (13). 1227-1235. 4) Clinical and Laboratory Standards Institute. Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline. CLSI document H59-A(ISBN 1-56238-747-2) ......

BASIC DATA
Standard ID YY/T 1240-2023 (YY/T1240-2023)
Description (Translated English) (D-dimer assay kit (immunoturbidimetric method))
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of International Standard 11.100.10
Word Count Estimation 14,132
Date of Issue 2023-01-13
Date of Implementation 2023-07-15
Drafting Organization The First Medical Center of the General Hospital of the Chinese People's Liberation Army, Beijing Institute of Medical Device Inspection, Beijing Medical Device Evaluation and Inspection Center, Jilin Provincial Drug Evaluation Center, Shandong Aikeda Biotechnology Co., Ltd., Sysmex Medical Electronics ( Shanghai) Co., Ltd., Beijing Stargao Diagnostic Products Trading Co., Ltd., Beijing Secside Technology Co., Ltd., Shenzhen Mindray Biomedical Electronics Co., Ltd.
Administrative Organization National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC 136)
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration
Summary This standard specifies the requirements, test methods, signs, labels and instructions for use, packaging, transportation and storage of D-dimer assay kit (immunoturbidimetric method). This standard applies to kit products for the determination of D-dimer by immunoturbidimetric method.