YY/T 1662-2019 PDF EnglishUS$199.00 · In stock · Download in 9 seconds
YY/T 1662-2019: Quality control material for clinical chemistry analyzer 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 1662-2019: Quality control material for clinical chemistry analyzer---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/YYT1662-2019Quality control material for clinical chemistry analyzer ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Biochemical analyzer Published on.2019-05-31 2020-06-01 implementation State Drug Administration issued ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. Publication of this document The organization does not assume responsibility for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136). This standard was drafted. Beijing Medical Device Inspection Institute, China Food and Drug Control Research Institute, Hitachi Diagnostic Products (Shanghai) Co., Ltd. Division Beijing Branch, Shanghai Fosun Long March Medical Science Co., Ltd., Beckman Coulter Trading (China) Co., Ltd., Beijing Lidman Biochemical Co., Ltd. Co., Ltd. The main drafters of this standard. Yang Zongbing, Sun Nan, Cheng Qing, Jin Huihong, Nie Ying, Ren Yikun. Biochemical analyzer1 ScopeThis standard specifies the requirements for quality control materials used on biochemical analyzers, including requirements, test methods, labels, instructions for use, Packaging, transportation and storage, etc. This standard applies to controls for biochemical analyzers with acceptable intervals/values intended for laboratory internal quality control purposes.2 Normative referencesThe following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 Reference material referencematerial One or more specified characteristics are sufficiently uniform and stable to have been proven to be suitable for use in measurement or nominal property testing substance. [GB/T 29791.1-2013, definition 3.58] 3.2 Quality control material Reference material used to measure quality control. [ISO Guide 30..2015, definition 2.22]4 requirements4.1 traits The state of the control and the normal appearance requirements, including the matrix, color, etc., should be specified. 4.2 Loading The net content when the liquid is in the state should be no less than the indicated value. 4.3 Acceptable interval/value The recommended acceptable interval/value (or inclusion interval) and its determination procedures should be given and should meet the following requirements. a) acceptable intervals/values should take into account the medical decision level or a suitable concentration point within the measurement interval; b) acceptable intervals/values shall be given together with the specified measuring system (reagents and instruments); c) the number of trials, the number of repetitions and the time limit for the evaluation of the acceptable interval/value; YY/T 1662-2019 Quality control material for clinical chemistry analyzer ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Biochemical analyzer Published on.2019-05-31 2020-06-01 implementation State Drug Administration issuedForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. Publication of this document The organization does not assume responsibility for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136). This standard was drafted. Beijing Medical Device Inspection Institute, China Food and Drug Control Research Institute, Hitachi Diagnostic Products (Shanghai) Co., Ltd. Division Beijing Branch, Shanghai Fosun Long March Medical Science Co., Ltd., Beckman Coulter Trading (China) Co., Ltd., Beijing Lidman Biochemical Co., Ltd. Co., Ltd. The main drafters of this standard. Yang Zongbing, Sun Nan, Cheng Qing, Jin Huihong, Nie Ying, Ren Yikun. Biochemical analyzer1 ScopeThis standard specifies the requirements for quality control materials used on biochemical analyzers, including requirements, test methods, labels, instructions for use, Packaging, transportation and storage, etc. This standard applies to controls for biochemical analyzers with acceptable intervals/values intended for laboratory internal quality control purposes.2 Normative referencesThe following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 Reference material referencematerial One or more specified characteristics are sufficiently uniform and stable to have been proven to be suitable for use in measurement or nominal property testing substance. [GB/T 29791.1-2013, definition 3.58] 3.2 Quality control material Reference material used to measure quality control. [ISO Guide 30..2015, definition 2.22]4 requirements4.1 traits The state of the control and the normal appearance requirements, including the matrix, color, etc., should be specified. 4.2 Loading The net content when the liquid is in the state should be no less than the indicated value. 4.3 Acceptable interval/value The recommended acceptable interval/value (or inclusion interval) and its determination procedures should be given and should meet the following requirements. a) acceptable intervals/values should take into account the medical decision level or a suitable concentration point within the measurement interval; b) acceptable intervals/values shall be given together with the specified measuring system (reagents and instruments); c) the number of trials, the number of repetitions and the time limit for the evaluation of the acceptable interval/value; ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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