PEG-20M毛細(xì)管柱測(cè)定 高分子材料浸提液中環(huán)氧乙烷遷移量
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產(chǎn)品名稱(chēng)：PEG-20M毛細(xì)管柱測(cè)定 高分子材料浸提液中環(huán)氧乙烷遷移量
產(chǎn)品型號(hào)：PEG-20M毛細(xì)管柱測(cè)定
產(chǎn)品廠商：浩瀚色譜（山東）應(yīng)用技術(shù)開(kāi)發(fā)有限公司
簡(jiǎn)單介紹
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PEG-20M毛細(xì)管柱測(cè)定 高分子材料浸提液中環(huán)氧乙烷遷移量的詳細(xì)介紹
高分子材料浸提液中環(huán)氧乙烷遷移量
高分子材料浸提液中環(huán)氧乙烷遷移量 詳細(xì)信息：
名稱(chēng)：毛細(xì)管柱
規(guī)格：30m*0.32mm*0.5um
型號(hào)：PEG-20M
應(yīng)用：植入性醫(yī)療器械 高分子材料 浸提液中有毒有害物質(zhì)的測(cè)定第 10 部分：環(huán)氧乙烷遷移量 氣相色譜法
高分子材料浸提液中環(huán)氧乙烷遷移量 測(cè)試譜圖：
Migration of ethylene oxide in polymer material extract
Migration amount of ethylene oxide in polymer material extracting solution Details:
Name: Capillary Column
Specification: 30m*0.32mm*0.5um
Model: PEG-20M
Application: Implantable medical devices, Polymer materials, Determination of toxic and hazardous substances in extracts. Part 10: Migration of ethylene oxide, Gas chromatography
1 Scope
This standard specifies the gas chromatography of ethylene oxide migration in polymer material extracts of implantable medical devices sterilized by ethylene oxide
Method of determination.
This standard applies to the determination of the migration of ethylene oxide in polymer material extracts of implantable medical devices sterilized by ethylene oxide.
The detection limit of ethylene oxide in this method is 0.1 mg/L.
2 Normative references
The following docu
Pieces. For undated reference docu
GB/T 6682 Analytical laboratory water specifications and experimental methods
GB/T 16886.12 Biological e
3 Principles of the method
Place the sample to be tested in a closed container, and heat it up to make the volatile compo
When the phases reach equilibrium, the gas in the headspace is directly extracted for gas chromatographic analysis. Qualitative by retention time, quantification by peak area, using external standard
Quantitative
Test spectrum of ethylene oxide migration in polymer material extract:
高分子材料浸提液中環(huán)氧乙烷遷移量 詳細(xì)信息：
名稱(chēng)：毛細(xì)管柱
規(guī)格：30m*0.32mm*0.5um
型號(hào)：PEG-20M
應(yīng)用：植入性醫(yī)療器械 高分子材料 浸提液中有毒有害物質(zhì)的測(cè)定第 10 部分：環(huán)氧乙烷遷移量 氣相色譜法
1 范圍
本標(biāo)準(zhǔn)規(guī)定了經(jīng)環(huán)氧乙烷滅菌的植入性醫(yī)療器械高分子材料浸提液中環(huán)氧乙烷遷移量的氣相色譜
法的測(cè)定方法。
本標(biāo)準(zhǔn)適用于經(jīng)環(huán)氧乙烷滅菌的植入性醫(yī)療器械高分子材料浸提液中環(huán)氧乙烷遷移量的測(cè)定。
本方法環(huán)氧乙烷的檢出限為0.1 mg/L。
2 規(guī)范性引用文件
下列文件對(duì)于本文件的應(yīng)用是必不可少的。凡是注日期的引用文件，僅注日期的版本適用于本文
件。凡是不注日期的引用文件，其新版本（包括所有的修改單）適用于本文件。
GB/T 6682 分析實(shí)驗(yàn)室用水規(guī)格和實(shí)驗(yàn)方法
GB/T 16886.12 醫(yī)療器械生物學(xué)評(píng)價(jià) 第12部分：樣品制備與參照材料
3 方法原理
將待測(cè)樣品置入一密閉的容器中，通過(guò)加熱升溫使揮發(fā)性組分從樣品基體中揮發(fā)出來(lái)，在氣液兩
相中達(dá)到平衡，直接抽取頂空部分氣體進(jìn)行氣相色譜分析。以保留時(shí)間定性，峰面積定量，采用外標(biāo)
法定量
高分子材料浸提液中環(huán)氧乙烷遷移量 測(cè)試譜圖：
Migration of ethylene oxide in polymer material extract
Migration amount of ethylene oxide in polymer material extracting solution Details:
Name: Capillary Column
Specification: 30m*0.32mm*0.5um
Model: PEG-20M
Application: Implantable medical devices, Polymer materials, Determination of toxic and hazardous substances in extracts. Part 10: Migration of ethylene oxide, Gas chromatography
1 Scope
This standard specifies the gas chromatography of ethylene oxide migration in polymer material extracts of implantable medical devices sterilized by ethylene oxide
Method of determination.
This standard applies to the determination of the migration of ethylene oxide in polymer material extracts of implantable medical devices sterilized by ethylene oxide.
The detection limit of ethylene oxide in this method is 0.1 mg/L.
2 Normative references
The following docu
Pieces. For undated reference docu
GB/T 6682 Analytical laboratory water specifications and experimental methods
GB/T 16886.12 Biological e
3 Principles of the method
Place the sample to be tested in a closed container, and heat it up to make the volatile compo
When the phases reach equilibrium, the gas in the headspace is directly extracted for gas chromatographic analysis. Qualitative by retention time, quantification by peak area, using external standard
Quantitative
Test spectrum of ethylene oxide migration in polymer material extract:
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