，由山東省醫(yī)療器械和藥品包裝檢驗研究院牽頭修訂的GB/T 14233.1-2022《醫(yī)用輸液、輸血、注射器具檢驗方法 第1部分：化學(xué)分析方法》（以下簡稱“新版GB/T 14233. 1”）發(fā)布，并將于2023年11月1日正式實施。GB/T 14233.1是醫(yī)用醫(yī)輸液、輸血、注射器具檢驗方法的系列標(biāo)準(zhǔn)之一，主要規(guī)定了相關(guān)化學(xué)分析方法包含檢驗液的制備、常規(guī)溶出物試驗方法以及材料中重金屬元素分析方法、環(huán)氧乙烷殘留量測試方法等。
采用氣相色譜法檢測環(huán)氧乙烷殘留量，制備供試液時有兩種基本的樣品浸提方法：模擬使用浸提法和極限浸提法。
環(huán)氧乙烷殘留量用相對含量表示，計算公式為：CEO=5c/m，兩個試驗組檢測結(jié)果均合格或不合格，以兩次結(jié)果平均值作為最終檢測結(jié)果。若兩個試驗組檢測結(jié)果為一個合格，另一個不合格，需重新進行檢測。
CEO—樣品中環(huán)氧乙烷殘留量，μg/g；
5—樣品溶液體積，mL；
c—標(biāo)準(zhǔn)曲線上找出的供試液相對的濃度，μg/mL；
m—稱樣質(zhì)量，g。
名稱：毛細管柱
固定相：6%氰丙基苯基94%二甲基聚硅氧烷
規(guī)格：30m×0.25mm×1.4μm
型號：HH-624
應(yīng)用：GB/T 14233.1-2022醫(yī)用輸液、輸血、注射器具檢驗方法 第1部分：化學(xué)分析方法
GBT14233.1-2008醫(yī)用輸液、輸血、注射器具檢驗方法第1部分：化學(xué)分析方法
GBT 14233.1-1998 醫(yī)用輸液、輸血、注射器具檢驗方法 第1部分：化學(xué)分析方法
The revised GB/T 14233.1-2022 "Inspection Methods for Medical Infusion, Transfusion, and Injection Equipment Part 1: Chemical Analysis Methods" (hereinafter referred to as the "new version GB/T 14233 1) Released and will be officially implemented on November 1, 2023. GB/T 14233.1 is one of the series of standards for the inspection methods of medical infusion, blood transfusion, and injection equipment. It mainly specifies the relevant chemical analysis methods, including the preparation of test solutions, conventional dissolution test methods, analysis methods for heavy metal elements in materials, and testing methods for residual ethylene oxide.
Gas chromatography is used to detect the residual amount of ethylene oxide. There are two basic sample extraction methods for preparing the test solution: simulated extraction method and extreme extraction method.
The residual amount of ethylene oxide is expressed as relative content, and the calculation formula is: CEO=5c/m. The test results of both test groups are qualified or unqualified, and the average of the two results is taken as the final test result. If one of the two experimental groups passes the test and the other fails, retesting is required.
CEO - residual amount of ethylene oxide in the sample, μ g/g;
5- Sample solution volume, mL;
C - The relative concentration of the test solution found on the standard curve, in μ g/mL;
M - sample weight, g.
Name: Capillary Column
Fixed phase: 6% cyanopropyl phenyl 94% dimethyl polysiloxane
Specification: 30m × 0.25mm × 1.4 μ m
Model: HH-624
Application: GB/T 14233.1-2022 Inspection Methods for Medical Infusion, Transfusion, and Injection Equipment Part 1: Chemical Analysis Methods
GBT14233.1-2008 Inspection Methods for Medical Infusion, Transfusion, and Injection Equipment Part 1: Chemical Analysis Methods
GBT 14233.1-1998 Inspection Methods for Medical Infusion, Transfusion, and Injection Equipment Part 1: Chemical Analysis Methods
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