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JJF 1529-2015 English PDFUS$329.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. JJF 1529-2015: Calibration Specification for Bacterial Endotoxin Analyzers Status: Valid
JJF 1529-2015: Calibration Specification for Bacterial Endotoxin Analyzers---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.(Bacterial Endotoxin analyzer calibration specification) People's Republic of China National Metrology Technical Specifications Bacterial Endotoxin analyzer calibration specification Issued on. 2015-06-15 2015-09-15 implementation The State Administration of Quality Supervision, Inspection and Quarantine released Bacterial Endotoxin analyzer calibration specification EndotoxinAnaly zers NFP. National Technical Committee biometric The main drafting units. China Institute of Metrology Participated in the drafting unit. Henan Institute of Metrology Guangdong Provincial Institute of Metrology Tianjin Tianda Tianfa Technology Co., Ltd. This specification entrusted to the National Technical Committee is responsible for interpreting biometric The main drafters of this specification. Fubo Jiang (China Institute of Metrology) Ding Feng Yuan (Henan Institute of Metrology) Zhao Shan (Tianjin Tianda Tianfa Technology Co., Ltd.) Drafters participate. Tang Zhiyu (China Institute of Metrology) Yang Jin-yong (Guangdong Institute of Metrology) Paul Zhijuan (Guangdong Institute of Metrology) table of ContentsIntroduction (Ⅱ) 1 Scope (1) 2. References (1) 3 terminology and units of measurement (1) 3.1 bacterial endotoxin units (1) The reaction time is 3.2 Consistency (1) 4 Overview (1) 5 Metrological characteristics (1) 5.1 transmittance consistency (1) 5.2 Zero drift (1) 5.3 Temperature indication error (1) 5.4 Temperature fluctuation (1) 5.5 hole temperature difference (1) The reaction time is 5.6 Consistency (2) Calibration Condition 6 (2) 6.1 environmental conditions (2) 6.2 standards and other measuring equipment (2) 7 calibration items and calibration methods (2) 7.1 transmittance consistency (2) 7.2 Zero drift (2) 7.3 Temperature indication error and temperature fluctuation (3) The temperature difference between the 7.4 hole (3) The reaction time is 7.5 Consistency (3) 8 calibration results expression (4) 9 Recalibration interval (4) A standard substance solution preparation and LAL solution Appendix (5) Appendix B shows the temperature error of measurement uncertainty evaluation sample (6) Appendix C calibration original record format (7) Appendix D calibration certificate (within the page) format (9)IntroductionDevelopment of this specification primarily with reference to the "People's Republic of China Pharmacopoeia." This specification is the first release. Bacterial Endotoxin analyzer calibration specification1 ScopeThis instruction applies to bacterial endotoxin analyzer (dynamic turbidity method) of calibration. 2. References This specification refers to the following documents. "People's Republic of China Pharmacopoeia" For dated references, only the dated edition applies to this specification; undated reference documents Member, the latest edition (including any amendments) applies to this specification.3 terminology and units of measurement3.1 the bacterial endotoxin units EUendotoxinunit Activity per bacterial endotoxin, 1EU within a toxin international units (IU) fairly. [ "People's Republic of China Pharmacopoeia"] The reaction time is 3.2 Consistency RTCreactiontimeconsistence Equipment testing different channels LAL with bacterial endotoxin standard substance after reaction the optical density reaches a pre-set The value of the degree of consistency required reaction time, with the relative standard deviation.4 OverviewBacterial endotoxin analyzer (hereinafter referred to as the instrument) is detected by LAL kinetic turbidimetric assay with anti-bacterial endotoxin It should be in the process of optical density (turbidity) to determine changes in bacterial endotoxin devices. The reaction time or turbidity increase speed The presence of bacterial endotoxin concentration and a certain relationship, draw toxins within the reaction time or working standard solution increased turbidity Acceleration - endotoxin concentrations of single or double logarithmic curve can be achieved by dynamic turbidimetric assay of the sample of bacterial virulence Quantification of the concentration. Instrument consists of a light source, thermostat heater, wells, test, display and storage system (including control software) And other components. Optical signals into electrical signals by the photoelectric sensor, and then by electronic circuits into digital signals, and finally The control software calculates reaches a certain predetermined reaction time required for the optical density or turbidity increase the speed. According to the prosecution Instruments Measuring wavelength of classification, can be divided into single-wavelength, dual wavelength.5 Metrological characteristics5.1 transmittance consistency 5.2 Zero drift 5.3 Temperature indication error 5.4 Temperature fluctuation The temperature difference between the 5.5 hole ......Basic dataStandard ID: JJF 1529-2015 (JJF1529-2015)Description (Translated English): Calibration Specification for Bacterial Endotoxin Analyzers Sector / Industry: Metrology & Measurement Industry Standard Classification of Chinese Standard: A61 Classification of International Standard: 17.020 Word Count Estimation: 14,184 Date of Issue: 2015-06-15 Date of Implementation: 2015-09-15 Regulation (derived from): AQSIQ Announcement 2015 No.72 Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine Summary: This Standard applies to bacterial endotoxin analyzer (dynamic turbidity method) of calibration. IMAGE
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