YY/T 1831-2021 English PDFUS$139.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1831-2021: Treponema pallidum antibodies detection kit (immunochromatographic method) Status: Valid
Basic dataStandard ID: YY/T 1831-2021 (YY/T1831-2021)Description (Translated English): Treponema pallidum antibodies detection kit (immunochromatographic method) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C44 Word Count Estimation: 7,712 Issuing agency(ies): State Drug Administration YY/T 1831-2021: Treponema pallidum antibodies detection kit (immunochromatographic method)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.Treponema pallidum antibodies detection kit (immunochromatographic method) ICS 11:100:10 CCSC44 People's Republic of China Pharmaceutical Industry Standard Treponema pallidum antibody detection kit (immunochromatography) Published on 2021-12-06 2023-05-01 Implementation Released by the State Drug Administration forewordThis document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted: Please note that some content of this document may be patented: Publication of this document Institutions do not assume responsibility for identifying patents: This document is proposed by the State Drug Administration: This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136): This document is drafted by: China National Institute for Food and Drug Control, Shanghai Clinical Testing Center, Guangzhou Wanfu Biotechnology Co:, Ltd: Company, Beijing Wantai Bio-Pharmaceutical Co:, Ltd:, Intech Innovation (Xiamen) Technology Co:, Ltd:, Aibo Bio-Pharmaceutical (Hangzhou) Co:, Ltd: Company, Abbott Medical Diagnostics Co:, Ltd: The main drafters of this document: Xia Deju, Wang Jinghua, Guan Lijing, Xian Yangling, Qin Rong, Wei Yunyun, Xiao Yingchun: Treponema pallidum antibody detection kit (immunochromatography)1 ScopeThis document specifies the requirements, test methods, identification, labeling and instructions for use of Treponema pallidum antibody detection kits (immunochromatography): Books, packaging, transportation and storage: This document is suitable for the qualitative determination of Treponema pallidum antibodies in human serum, plasma or whole blood based on the principle of immunochromatography: Treponema pallidum antibody detection kits such as body gold method and latex method:2 Normative referencesThe contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document: GB/T 191 Graphical signs of packaging, storage and transportation GB/T 29791:2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2: In vitro diagnostic reagents for professional use3 Terms and DefinitionsThere are no terms and definitions that need to be defined in this document:4 Requirements4:1 Appearance The appearance should meet the following requirements: a) The components of the kit should be complete and complete, and the liquid should not leak; b) Chinese packaging labels should be clear and free of wear: 4:2 Physical inspection Physical inspection should meet the following requirements: a) The width of the film strip should be greater than or equal to 2:5mm; b) The liquid moving speed should be greater than or equal to 10mm/min: 4:3 Conformance rate of negative reference products Use the national negative reference product for testing, the positive reaction should not be more than 2 copies, and the conformity rate (-/-) of the negative reference product should be greater than or equal to 18/ 20; Or use a standardized negative reference substance for testing, and the results should meet the corresponding requirements: Note: See Appendix A for the national negative reference product information involved in this document: ...... |
