YY/T 1663-2019 PDF EnglishUS$199.00 · In stock · Download in 9 seconds
YY/T 1663-2019: Progesterone testing kit 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 1663-2019: Progesterone testing kit---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/YYT1663-2019Progesterone testing kit ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Progesterone assay kit 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, Siemens Medical Diagnostic Products (Shanghai) Co., Ltd., Roche Diagnostics (on Hai) Co., Ltd., Weihai Weigao Biotechnology Co., Ltd. The main drafters of this standard. Yan Zhenyu, Wang Shaoying, Cai Xiaorong, Meng Hongsheng. Progesterone assay kit1 ScopeThis standard specifies the requirements, test methods, labels, instructions for use, and packaging, transportation, and storage of the progesterone test kit. This standard is applicable to kits for progesterone determination (hereinafter referred to as kits), including quantification by enzyme labeling, chemiluminescent labeling, etc. An immunoassay kit for determining progesterone. This standard does not apply to. qualitative or semi-quantitative determination of progesterone reagents by colloidal gold or other methods (eg test strips, biocores) Film, etc.).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 191 packaging storage and transportation icon GB/T 21415 in vitro diagnostic medical device biological sample medium quantity measurement calibrator and control substance evaluation Source GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents3 requirements3.1 Appearance Appropriate appearance requirements should be specified according to the packaging characteristics of the product. Generally, there should be components and traits of each component of the kit; internal and external packaging and labels Clear and other requirements. 3.2 Traceability The manufacturer shall provide the source, assignment process and uncertainty of the kit calibration product according to GB/T 21415 and relevant regulations. content. 3.3 Accuracy Accuracy should be in accordance with one of the following requirements, if applicable, the method of relative deviation is preferred. a) using a Certified Reference Material (CRM) or other recognized reference material that can be used to evaluate conventional methods as a sample, The relative deviation between the measured value and the marked value should be within ±15%; b) The recovery rate should be in the range of 85% to 115%. 3.4 Checkout limit The detection limit should be ≤1.2nmol/L. 3.5 linear range The linear interval is not narrower than 1.2nmol/L~100nmol/L, and the correlation coefficient of the kit is within the linear range specified by the manufacturer. YY/T 1663-2019 Progesterone testing kit ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Progesterone assay kit 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, Siemens Medical Diagnostic Products (Shanghai) Co., Ltd., Roche Diagnostics (on Hai) Co., Ltd., Weihai Weigao Biotechnology Co., Ltd. The main drafters of this standard. Yan Zhenyu, Wang Shaoying, Cai Xiaorong, Meng Hongsheng. Progesterone assay kit1 ScopeThis standard specifies the requirements, test methods, labels, instructions for use, and packaging, transportation, and storage of the progesterone test kit. This standard is applicable to kits for progesterone determination (hereinafter referred to as kits), including quantification by enzyme labeling, chemiluminescent labeling, etc. An immunoassay kit for determining progesterone. This standard does not apply to. qualitative or semi-quantitative determination of progesterone reagents by colloidal gold or other methods (eg test strips, biocores) Film, etc.).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 191 packaging storage and transportation icon GB/T 21415 in vitro diagnostic medical device biological sample medium quantity measurement calibrator and control substance evaluation Source GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents3 requirements3.1 Appearance Appropriate appearance requirements should be specified according to the packaging characteristics of the product. Generally, there should be components and traits of each component of the kit; internal and external packaging and labels Clear and other requirements. 3.2 Traceability The manufacturer shall provide the source, assignment process and uncertainty of the kit calibration product according to GB/T 21415 and relevant regulations. content. 3.3 Accuracy Accuracy should be in accordance with one of the following requirements, if applicable, the method of relative deviation is preferred. a) using a Certified Reference Material (CRM) or other recognized reference material that can be used to evaluate conventional methods as a sample, The relative deviation between the measured value and the marked value should be within ±15%; b) The recovery rate should be in the range of 85% to 115%. 3.4 Checkout limit The detection limit should be ≤1.2nmol/L. 3.5 linear range The linear interval is not narrower than 1.2nmol/L~100nmol/L, and the correlation coefficient of the kit is within the linear range specified by 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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