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YY/T 1198-2013 English PDF

YY/T 1198-2013 (YY/T1198-2013, YYT 1198-2013, YYT1198-2013)
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YY/T 1198-2013English150 Add to Cart 0--9 seconds. Auto-delivery Aspartate aminotransferase diagnostic kit (IFCC method) Valid YY/T 1198-2013
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BASIC DATA
Standard ID YY/T 1198-2013 (YY/T1198-2013)
Description (Translated English) Aspartate aminotransferase diagnostic kit (IFCC method)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 10,188
Quoted Standard YY/T 0466.1; GB/T 191
Drafting Organization Chinese Institute of Food and Drug test
Administrative Organization National medical clinical laboratory testing and in vitro diagnostic systems Standardization Technical Committee
Regulation (derived from) State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Proposing organization State Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the aspartate aminotransferase measurement principle enzyme assay kit (IFCC method), requirements, test methods, marking, labeling and instructions for use, packaging, transport and storage of John. This standard applies to asparta


YY/T 1198-2013 YY ICS 11.100 C 44 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA Aspartate aminotransferase diagnostic kit (IFCC method) ISSUED ON. OCTOBER 21, 2013 IMPLEMENTED ON. OCTOBER 1, 2014 Issued by. State Food and Drug Administration Table Contents Foreword ... 3  1 Scope ... 4  2 Normative References ... 4  3 Determination Principle ... 4  4 Requirements ... 4  5 Test Method ... 6  6 Mark, Label and Instructions ... 9  7 Packaging, Transport and Storage ... 10  Foreword  This Standard was drafted in accordance with the rules specified in GB/T 1.1-2009. Please note that some contents in this Document may involve patents. The issuing organization of this Document does not undertake the responsibility to identify these patents. This Standard was proposed by State Food and Drug Administration. This Standard shall be under the jurisdiction of the China Clinical Laboratory Testing and In vitro Diagnostic Test System of Standardization Administration of China (SAC/TC 136). Drafting organization of this Standard. National Institute for Food and Drug Control. The main drafters of this Standard. Wang Yumei, Huang Jie, Liu Yan, and Gao Shangxian. Aspartate aminotransferase diagnostic kit (lFCC method) 1 Scope  This standard specifies the determination principle, requirements, test method, marks, signs, instructions, packaging, transport and storage of aspartate aminotransferase diagnostic kit (lFCC method). This standard applies to the quality control of aspartate aminotransferase diagnostic kit (lFCC method) This product is used for in-vitro quantitative determination of the aspartate aminotransferase activity in human serum or plasma. 2 Normative References  The following documents are indispensable for the application of this Document. For dated references, only dated edition applies to this document. For undated references, the latest edition (including all amendments) applies 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 requirements GB/T 191 Packaging - Pictorial Marking for Handling of Goods 3 Determination Principle  This method is the method recommended by IFCC. The reaction equation of method principle is as follows. L-aspartic acid + α-ketoglutaric acid → oxaloacetic acid + L-glutamic acid Oxaloacetic acid + NADH + H+ → L-malic acid + NAD+ In the above coupled reaction, the oxidation rate of NADH is proportional to the enzymatic activity of the specimen. NADH has characteristic absorption peak at the wavelength of 340 nm. Therefore, the activity of ALT can be calculated through measuring the decline rate of NADH absorbance. The amino of L-aspartic acid will be transferred to malic dehydrogenase (MDH) under the catalysis of AST. Then carry out coupled reaction; oxidize the NADH to NAD+. NADH has characteristic absorption peak at the wavelength of 340 nm. Its oxidation rate is proportional to the activity of AST in serum. Therefore, the activity of ALT (U/L) can be calculated through measuring the decline rate of NADH absorbance at 340 nm. 4 Requirements  4.1 Appearance It shall meet the appearance requirements specified by the manufacturer. AST MDH 5.8 Stability Take the reagent (kit), which is stored to the expiry of validity period under the specified storage conditions OR under the accelerated test conditions specified by the manufacturer, for test. It shall meet the requirements of 4.8. 6 Mark, Label and Instructions  6.1 Mark and label of kit packaging box The packaging-pictorial marking for handling of goods shall meet the requirements of GB/T 191, and shall include at least the following contents. a) Product name and specification; b) Production batch number; c) Expiry date; d) Storage conditions. 6.2 Mark and label of single kit packaging bottle The single kit packaging bottle shall include the following contents. a) Product name and specification; b) Trademark; c) Net content of product; d) Production batch number; e) Expiry date; f) Storage conditions. 6.3 Instructions The instructions shall include the following contents. a) Product name; b) Packaging specification; c) Intended use; d) Test principle; e) Main components; f) Storage conditions and expiry date; g) Applicable instruments; h) Sample requirements; i) Test method; j) Reference value (reference interval); k) Explanation of test results; l) Limitation of the test method; m) Product performance index; n) Precautions; o) References; p) Manufacturing enterprise; q) Production enterprise license number of medical device; r) Registration certificate number of medical device; s) Product standard number; t) Approval and modification date of the instructions. 7 Packaging, Transport and Storage  7.1 Packaging 7 1.1 Packaging for storage and transport The packaging for storage and transport AND marking of the kit shall meet the requirements of GB/T 191. 7.1.2 Unit packaging 7.1.2.1 The kit shall be complete, labeled clearly, sealed tightly, and free of leakage. 7.1.2.2 The instructions shall be enclosed within the kit. 7.2 Transport Product transport shall be carried out according to the provisions of contract. 7.3 Storage Kit shall be stored under the conditions specified by the manufacturer. ......