YY/T 1203-2013 English PDFUS$209.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1203-2013: Sodium assay kit(Enzymic method) Status: Valid
Basic dataStandard ID: YY/T 1203-2013 (YY/T1203-2013)Description (Translated English): Sodium assay kit(Enzymic method) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C44 Classification of International Standard: 11.100 Word Count Estimation: 9,910 Quoted Standard: YY/T 0466.1 Regulation (derived from): State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies: sodium assay kit (enzymatic) Determination of Principles, requirements, test methods, marking, labeling and instructions for use, packaging, transportation and storage. This standard applies to: sodium assay kit (enzymatic) Qualit YY/T 1203-2013: Sodium assay kit(Enzymic 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.Sodium assay kit (Enzymic method) ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Sodium assay kit (enzymatic) Issued on. 2013-10-21 2014-10-01 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 standard may involve patents. The standard release 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. Chinese Academy of Food and Drug test. The main drafters of this standard. Sun Nan, Wang Yumei, Liu Yan, the first noble, Zhangchun Tao. Sodium assay kit (enzymatic)1 ScopeThis standard specifies the sodium assay kit (enzymatic) requirements, test methods, marking, labeling and instructions for use, packaging, transport and storage. This standard applies to soda assay kit (enzymatic) quality control.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. Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements3 Requirements3.1 Appearance Compatible with the manufacturer's normal appearance requirements. 3.2 PACKING Loading amount of the liquid reagent to be less than the labeled amount. 3.3 reagent blank 3.3.1 Reagent blank absorbance Reagent blank absorbance ≤1.0 (wavelength 405nm, light trails 1.0cm). 3.3.2 Reagent blank absorbance change rate Reagent blank absorbance change rate ≤0.500/min (wavelength 405nm, light trails 1.0cm). 3.4 Linear Interval In 90mmol/L ~ 160mmol/L range, the linear correlation coefficient (r) shall not be less than 0.9900. 3.5 Accuracy You can use the following methods. a) relative deviation. serum assay provides reference material or reference values of the reference method, the deviation measured value and the value declared in within ± 15.0%; b) recovering the experiment. The determination of calibrator, kits recovery should be within 90% to 110%; c) comparative experiments. no calibrator to comparison method for determining, r≥0.9900. 3.6 Sensitivity Analysis When reagent (kit) test analyte absorbance difference (ΔA) or change in absorbance should be consistent with manufacturer's given range. ...... |
