固定相：有機(jī)擔(dān)體

粒度：80-100目，60-80目

規(guī)格：2m*4mm

型號(hào)：407有機(jī)擔(dān)體

應(yīng)用：

GBT 14233.1-1998 醫(yī)用輸液、輸血、注射器具檢驗(yàn)方法 第1部分：化學(xué)分析方法
GB 18279-2000 醫(yī)療器械環(huán)氧乙烷滅菌確認(rèn)和常規(guī)控制

GB 19335-2003 一次性使用血路產(chǎn)品 通用技術(shù)條件

GB14233.1-2008-T 醫(yī)用輸液、輸血、注射器具檢驗(yàn)方法  第１部分：化學(xué)分析方法
GB T 16886.7-2015 醫(yī)療器械生物學(xué)評(píng)價(jià) 第7部分 環(huán)氧乙烷滅菌殘留量

環(huán)氧乙烷是一種運(yùn)用廣泛的滅菌劑，對(duì)細(xì)菌、病毒、真菌、芽胞等都具有良好的滅菌效果。環(huán)氧乙烷滅菌是目前醫(yī)療器械滅菌的主要方式之一，目前醫(yī)療器械滅菌的市場份額，環(huán)氧乙烷占據(jù)了約一半左右。

滕州市浩瀚色譜儀器技術(shù)服務(wù)有限公司，采用407有機(jī)擔(dān)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(yī)療器械中環(huán)氧乙烷殘留量,實(shí)驗(yàn)結(jié)果表明:環(huán)氧乙烷濃度為0~5.00μg/mL時(shí),線性關(guān)系良好(R=0.9996),檢出限低、相對(duì)標(biāo)準(zhǔn)偏差小、回收率高.該方法有效.

頂空氣相色譜法測(cè)定醫(yī)療器械中環(huán)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