产品名称：	GDX-407填充柱 测定医疗防护用品中环氧乙烷残留量GB/T 16886.7-2015
产品型号：	GDX-407填充柱
品牌：	1356
产品数量：
产品单价：	面议
日期:	2022-05-01

GDX-407填充柱 测定医疗防护用品中环氧乙烷残留量GB/T 16886.7-2015的详细资料

测定医疗防护用品中环氧乙烷残留量GB/T 16886.7-2015
测定医疗防护用品中环氧乙烷残留量GB/T 16886.7-2015 详细信息：

名称：填充柱

固定相：有机担体

粒度：80-100目，60-80目

规格：2m*4mm,2m*3mm ,2m*1*8

型号：407有机担体 ，GDX-407
应用:  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

浩瀚色谱（山东）应用技术开发有限公司建立气相色谱法检测口罩、防护服等医疗防护用品中环氧乙烷的残留量,为生产厂家改进灭菌工艺提供数据支持。气相色谱法采用顶空进样、FID检测器,环氧乙烷的质量浓度在0.5～8 μg/mL范围内与色谱峰面积线性关系良好,检出限为0.10 μg/g,定量限为0.35 μg/g。环氧乙烷测定结果的相对标准偏差为1.73%（n=6）,平均加标回收率为94.3%～99.3%。该方法操作简便,精密度、准确度较高,适用于医疗防护用品中环氧乙烷的测定。 

测定医疗防护用品中环氧乙烷残留量GB/T 16886.7-2015   测试谱图：




Determination of ethylene oxide residues in medical protective equipment GB/T 16886.7-2015
Determination of ethylene oxide residues in medical protective equipment GB/T 16886.7-2015 Details:

Name: Packed Column

Stationary Phase: Organic Support

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

Specifications: 2m*4mm, 2m*3mm, 2m*1*8

Model: 407 organic carrier, GDX-407
Application: GB/T 16886.7-2015 Biological evaluation of Medical Devices Part 7: Residues of Ethylene Oxide Sterilization



Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. has established a gas chromatography method to detect the residual amount of ethylene oxide in medical protective equipment such as masks and protective clothing, and provide data support for manufacturers to improve the sterilization process. Gas chromatography adopts headspace injection and FID detector. The mass concentration of ethylene oxide has a good linear relationship with the chromatographic peak area in the range of 0.5-8 μg/mL. The detection limit is 0.10 μg/g, and the quantification limit is 0.35. μg/g. The relative standard deviation of the determination results of ethylene oxide was 1.73% (n=6), and the average recovery was 94.3%-99.3%. The method is easy to operate, has high precision and accuracy, and is suitable for the determination of ethylene oxide in medical protective equipment.

Determination of ethylene oxide residues in medical protective equipment GB/T 16886.7-2015 Test spectrum: