YY/T 1220-2013 PDF EnglishUS$150.00 · In stock · Download in 9 seconds
YY/T 1220-2013: Creatine kinase isoenzyme MB (CK-MB) diagnostic kit (Colloid gold method) Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
YY/T 1220-2013: Creatine kinase isoenzyme MB (CK-MB) diagnostic kit (Colloid gold method)---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1220-2013YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.100 C 44 (Creatine Kinase Isoenzyme MB) (CK-MB) Diagnostic Kit (Colloid Gold Method) Issued on. OCTOBER 21, 2013 Implemented on. OCTOBER 01, 2014 Issued by. China Food and Drug Administration Table of ContentsForeword... 3 1 Scope... 4 2 Normative References... 4 3 Terms and Definitions... 4 4 Requirements... 5 5 Test Methods... 6 6 Inspection and Judgment... 8 7 Marking, Label and Instruction Manual... 8 8 Packaging, Transportation and Storage... 9 Bibliography... 10ForewordThis Standard was drafted as per the rules specified in GB/T 1.1-2009. Please note some contents of this document may involve patents. The issuing agency of this document shall not assume the responsibility to identify these patents. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of National Technical Committee on System of Medical Clinical Test Lab and In Vitro Diagnostic System of Standardization Administration of China (SAC/TC 136). Drafting staffs of this Standard. National Institutes for Food and Drug Control. Chief drafting staffs of this Standard. Huang Jie, Qu Shoufang, and Gao Shangxian. (Creatine Kinase Isoenzyme MB) (CK-MB) Diagnostic Kit (Colloid Gold Method)1 ScopeThis Standard specifies the terms and definitions, requirements, test methods, inspection and judgment, marking, label, instruction manual, packaging, transportation and storage of the creatine kinase isoenzyme MB (CK-MB) diagnostic kit (colloid gold method). This Standard is applicable to the creatine kinase isoenzyme MB (CK-MB) diagnostic kit (colloid gold method). This reagent is used to qualitatively detect the activity of creatine kinase isoenzyme MB (CK-MB) in human serum or plasma in vitro.2 Normative ReferencesThe following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this document. YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied - Part 1.General Requirements3 Terms and DefinitionsFor the purpose of this document, the following terms and definitions apply. 3.1 Colloid gold technique A labeling technique that uses colloidal gold particles as a tracer or chromogenic substance for antigen-antibody reaction or other molecular detection. 3.2 Lowest detection limit The lowest measured value in a sample that can be declared different from zero with a certain probability. 3.3 Analytical specificity The measurement program only measures the ability to be measured.4 Requirements4.1 Physical properties 4.2 Accuracy Test the positive control materials of creatine kinase isoenzyme MB (CK-MB), all the results shall be positive. 4.3 Repeatability Take 10 pieces of test papers of the same batch number to test the positive control materials of creatine kinase isoenzyme MB (CK-MB) with the same concentration; the reaction results shall be consistent, the color shall be uniform, and all shall be positive. 4.4 Analytical specificity Test the specificity control materials of creatine kinase isoenzyme MB (CK-MB), the reaction result shall be negative. 4.6 Stability Take the test papers of the same batch number and place them at 37°C for 20d. The result shall meet the requirements of 4.2~4.5.5 Test Methods5.1 Basis for result judgment (see Figure 1) 5.1.1 Positive. The color of the color band of the test line (T) is the same as or deeper than the control line (C). 5.1.2 Negative. Only the control line (C) appears. 5.2 Physical properties 5.2.1 Appearance Randomly select 1 piece of test paper and visually observe it under natural light. It shall meet the requirements of 4.1.1. 5.3 Accuracy Test the positive control materials of the creatine kinase isoenzyme MB (CK-MB); operate according to the instruction manual; and the results shall meet the requirements of 4.2. 5.4 Repeatability Test the positive control materials of the creatine kinase isoenzyme MB (CK-MB) with the same concentration; and operate according to the instruction manual; the result shall meet the requirements of 4.3. 5.6 Lowest detection limit Test the sensitivity control materials of the creatine kinase isoenzyme MB (CK-MB); and operate according to the instruction manual; the results shall meet the requirements of 4.5. 5.7 Stability Take the test papers of the same batch number and place them at 37°C for 20d; and test according to the methods shown in 5.3 ~ 5.6.The result shall meet the requirements of 4.6.6 Inspection and Judgment6.1 Reagent (kit) inspection type Reagent (kit) inspection is divided into exit-factory inspection and type inspection. 6.2 Exit-factory inspection The exit-factory inspection items are 4.1~4.6; and the products may leave the factory only after the inspection is qualified; if any of the inspection results does not meet the requirements, a re-inspection shall be carried out. 6.3 Type inspection Type inspection items are all items; and each batch of products shall be all-item inspected according to this Standard. Type inspection shall be carried out in one of the following situations.7 Marking, Label and Instruction Manual7.1 The outer packaging box of the reagent (box) shall have at least the following contents. 7.2 The product instruction manual shall have the following content.8 Packaging, Transportation and Storage8.1 Packaging It shall be intact, no leakage, and without damage. 8.2 Transportation The reagents (kits) shall be transported according to the requirements of the manufacturer. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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