407 頂空氣相色譜法測定醫療器械中環氧乙烷

固定相：有機擔體

粒度：80-100目，60-80目

規格：2m*4mm

型號：407有機擔體

應用：

GBT 14233.1-1998 醫用輸液、輸血、注射器具檢驗方法 第1部分：化學分析方法
GB 18279-2000 醫療器械環氧乙烷滅菌確認和常規控制

GB 19335-2003 一次性使用血路產品 通用技術條件

GB14233.1-2008-T 醫用輸液、輸血、注射器具檢驗方法  第１部分：化學分析方法
GB T 16886.7-2015 醫療器械生物學評價 第7部分 環氧乙烷滅菌殘留量

環氧乙烷是一種運用廣泛的滅菌劑，對細菌、病毒、真菌、芽胞等都具有良好的滅菌效果。環氧乙烷滅菌是目前醫療器械滅菌的主要方式之一，目前醫療器械滅菌的市場份額，環氧乙烷占據了約一半左右。

滕州市浩瀚色譜儀器技術服務有限公司，采用407有機擔體作為固定相的色譜柱,采用水作萃取液,利用氣相色譜法分析醫療器械中環氧乙烷殘留量,實驗結果表明:環氧乙烷濃度為0~5.00μg/mL時,線性關系良好(R=0.9996),檢出限低、相對標準偏差小、回收率高.該方法有效.

頂空氣相色譜法測定醫療器械中環氧乙烷 圖片：


Determination of ethylene oxide in medical devices by headspace gas chromatography
Determination of Ethylene Oxide in Medical Devices by Headspace Gas Chromatography

Stationary phase: organic carrier

Particle size: 80-100 mesh, 60-80 mesh

Specification: 2m*4mm

Model: 407 organic carrier

application:

GBT 14233.1-1998 Medical infusions, blood transfusions
GB 18279-2000 Confirmation and routine control of ethylene oxide sterilization for medical devices

GB 19335-2003 One-time use of blood products General technical conditions

GB14233.1-2008-T Medical infusion, blood transfusion, and injecting machines - Test methods - Part 1
GB T 16886.7-2015 Biological evaluation of medical devices - Part 7

Ethylene oxide is a widely used sterilizing agent with good sterilization effects on bacteria, viruses, fungi, and spores. Ethylene oxide sterilization is one of the main methods of sterilization of medical devices. Currently, the global market share of medical device sterilization accounts for about half of ethylene oxide.

Tengzhou Haohao Chromatography Instrument Technology Service Co., Ltd. uses 407 organic carrier as the stationary phase column and uses water as the extract to analyze the residual ethylene oxide in medical devices by gas chromatography. The experimental results show that: ethylene oxide When the concentration is 0~5.00μg/mL, the linear relationship is good (R=0.9996), the detection limit is low, the relative standard deviation is small, and the recovery rate is high. The method is reliable and effective.

Determination of Ethylene Oxide in Medical Devices by Headspace Gas Chromatography