YY/T 1255-2015 English PDFUS$189.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1255-2015: Immunoturbidimetry reagent (kit) Status: Valid
Basic dataStandard ID: YY/T 1255-2015 (YY/T1255-2015)Description (Translated English): Immunoturbidimetry reagent (kit) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C44 Classification of International Standard: 11.100 Word Count Estimation: 9,942 Date of Issue: 2015-03-02 Date of Implementation: 2016-01-01 Quoted Standard: GB/T 21415 Regulation (derived from): The State Food and Drug Administration Announcement 2015 No. 8 Issuing agency(ies): State Food and Drug Administration Summary: This Standard specifies the immunoturbidimetric assay reagent (kit) (transmission method) of terms and definitions, requirements and test methods, marking, labeling and instructions for use, packaging, transportation and storage. This Standard applies to the transmission based on the principles of immunoturbidimetry on semi-automatic biochemical analyzer, or other types of analyzers for quantitative reagent (kit). YY/T 1255-2015: Immunoturbidimetry reagent (kit)---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.Immunoturbidimetry reagent (kit) ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Immunoturbidimetric assay reagent (kit) (transmission method) Issued on. 2015-03-02 2016-01-01 implementation China Food and Drug Administration released ForewordThis standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Distribution of this document Institutions do not assume the responsibility to identify these patents. This standard was proposed by the China Food and Drug Administration. This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized. This standard was drafted. Beijing Medical Device Testing, Shanghai Fuxing Changzheng Medical Science Co., Beckman Coulter laboratory frame EC (Suzhou) Co., Ltd., Sichuan Mike Biotechnology Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd. The main drafters of this standard. Bi Chunlei, Wu Jie, Kang Juan, Zhang Yan, Chen Qiyun, Tian Wei. Immunoturbidimetric assay reagent (kit) (transmission method)1 ScopeThis standard specifies the immunoturbidimetric assay reagent (kit) (transmission method) terms and definitions, requirements and test methods, marking, labeling, and so With instructions, packaging, transportation and storage. This standard applies to transmission-based Immunoturbidimetry principle, the semi-automatic biochemical analyzer or other type of analyzer given Amount detection reagent (box).2 Normative referencesThe following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 21415 in vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials assigned metrological traceability Derived3 Terms and DefinitionsThe following terms and definitions apply to this document. 3.1 Immunoturbidimetry immunoturbidimetry In the reaction solution, and the antibody-antigen complex formed by precipitation, so that increase in turbidity. When light passes through the reaction solution, some of the light is like Product scattering some of the light is absorbed by the sample, the remaining light transmitted through the sample. The method of measuring the light absorption of the sample is immune nephelometry. Turbidimetric is Spectrophotometric determination Principle. In a fixed-angle scattered light scattering measurements turbidity (nephelometry). Analyte concentration can be obtained by comparison with known concentration calibration solution is measured. 3.2 Blank limit limitofblank; LoB Under certain probability, by a given measurement procedures measure up to the measurement results may be obtained blank sample. [CLSIEP17-A, 3]4 requirements and test methods4.1 Appearance Appearance should meet the following requirements. a) the components of the kit should be complete, complete, no liquid leakage; b) packaging label text symbols should be clear. 4.2 PACKING Packed reagent amount not less than the indicated value. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1255-2015_English be delivered?Answer: Upon your order, we will start to translate YY/T 1255-2015_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 1255-2015_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1255-2015_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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