407 顶空气相色谱法测定医疗器械中环氧乙烷

固定相：有机担体

粒度：80-100目，60-80目

规格：2m*4mm

型号：407有机担体

应用：

GBT 14233.1-1998 医用输液、输血、注射器具检验方法 第1部分：化学分析方法
GB 18279-2000 医疗器械环氧乙烷灭菌确认和常规控制

GB 19335-2003 一次性使用血路产品 通用技术条件

GB14233.1-2008-T 医用输液、输血、注射器具检验方法  第１部分：化学分析方法
GB T 16886.7-2015 医疗器械生物学评价 第7部分 环氧乙烷灭菌残留量

环氧乙烷是一种运用广泛的灭菌剂，对细菌、病毒、真菌、芽胞等都具有良好的灭菌效果。环氧乙烷灭菌是目前医疗器械灭菌的主要方式之一，目前医疗器械灭菌的市场份额，环氧乙烷占据了约一半左右。

滕州市浩瀚色谱仪器技术服务有限公司，采用407有机担体作为固定相的色谱柱,采用水作萃取液,利用气相色谱法分析医疗器械中环氧乙烷残留量,实验结果表明:环氧乙烷浓度为0~5.00μg/mL时,线性关系良好(R=0.9996),检出限低、相对标准偏差小、回收率高.该方法有效.

顶空气相色谱法测定医疗器械中环氧乙烷 图片：


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