YY/T 1194-2011 English PDFUS$349.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1194-2011: α-Amylase test reagent(kit) (continuous-monitoring procedure) Status: Valid
Basic dataStandard ID: YY/T 1194-2011 (YY/T1194-2011)Description (Translated English): ��-Amylase test reagent(kit) (continuous-monitoring procedure) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C44 Classification of International Standard: 11.100 Word Count Estimation: 15,129 Date of Issue: 2011-12-31 Date of Implementation: 2013-06-01 Quoted Standard: YY/T 0316; YY/T 0466.1 Regulation (derived from): Industry standard filing Notice 2013 No. 6 (No. 162 overall) Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the ��- amylase assay reagent (box) the terms and definitions, classification and nomenclature, technical requirements, test methods, labels, brochures, packaging, transportation and storage requirements. This standard applies to the use of continuous monitoring method for serum, plasma, urine and other body fluids, ��- amylase activity for quantitative detection of ��- amylase assay reagent (box), including manual reagents and in semi-automatic biochemical analyzer reagent used. YY/T 1194-2011: α-Amylase test reagent(kit) (continuous-monitoring procedure)---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.α-Amylase test reagent (kit) (continuous-monitoring procedure) ICS 11.100 C44 People's Republic of China pharmaceutical industry standards α- amylase assay reagent (kit) (continuous monitoring method) Issued on. 2011-12-31 2013-06-01 implementation State Food and Drug Administration issued 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 State 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, BIOSINO Biotechnology Co., Ltd., Shanghai Fuxing Changzheng Medicine Optical Co., Ltd., China Pharmaceutical and Biological Products in vitro diagnostic reagents and media room, Jiang Xi Tekang Technology Limited. The main drafters of this standard. Wang Jun, Zhang Yongqin, Wu Jie, Liu Yan, Xiao Yan. α- amylase assay reagent (kit) (continuous monitoring method)1 ScopeThis standard specifies the α- amylase assay reagent (box) terms and definitions, classification and naming, technical requirements, test methods, labels, Brochures, packaging, transportation and storage requirements. This standard applies to serum, plasma, urine and other body fluids α- amylase activity quantitative detection method using continuous monitoring α- amylase Assay reagent (kit), including manual reagents and on the semi-automatic biochemical analyzer used.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. YY/T 0316 Medical Devices Risk Management for Medical Device Applications Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements3 Terms and DefinitionsThe following terms and definitions apply to this document. 3.1 Continuous monitoring method continuous-monitoring Under optimum conditions the enzyme reaction, multi-point monitoring throughout the course of the enzymatic reaction product or a reaction in the substrate due to changes over time Case, the reaction rate constant period, in the initial reaction rate per unit time of enzyme activity concentration of the enzyme was calculated.4 Requirements4.1 Appearance In line with the provisions of the company's normal appearance requirements. 4.2 Net content Net content of the liquid reagent to be less than indicated value. 4.3 reagent blank 4.3.1 Reagent blank absorbance Blank absorbance should be less than 0.35. 4.3.2 Reagent blank absorbance change rate With saline as the test sample was added to the reagent, the reagent blank absorbance change rate (ΔA/min) should be no more than 0.002. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1194-2011_English be delivered?Answer: Upon your order, we will start to translate YY/T 1194-2011_English as soon as possible, and keep you informed of the progress. 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