PEG-20M毛细管柱测定高分子材料浸提液中环氧乙烷迁移量_填充柱

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产品名称：	PEG-20M毛细管柱测定高分子材料浸提液中环氧乙烷迁移量
产品型号：	PEG-20M毛细管柱测定
品牌：	1941
产品数量：
产品单价：	面议
日期:	2021-11-28

PEG-20M毛细管柱测定高分子材料浸提液中环氧乙烷迁移量的详细资料

高分子材料浸提液中环氧乙烷迁移量
高分子材料浸提液中环氧乙烷迁移量 详细信息：

名称：毛细管柱
规格：30m*0.32mm*0.5um
型号：PEG-20M
应用：植入性医疗器械高分子材料浸提液中有毒有害物质的测定第 10 部分：环氧乙烷迁移量气相色谱法

1 范围

本标准规定了经环氧乙烷灭菌的植入性医疗器械高分子材料浸提液中环氧乙烷迁移量的气相色谱

法的测定方法。

本标准适用于经环氧乙烷灭菌的植入性医疗器械高分子材料浸提液中环氧乙烷迁移量的测定。

本方法环氧乙烷的检出限为0.1 mg/L。

2 规范性引用文件

下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文

件。凡是不注日期的引用文件，其新版本（包括所有的修改单）适用于本文件。

GB/T 6682 分析实验室用水规格和实验方法

GB/T 16886.12 医疗器械生物学评价第12部分：样品制备与参照材料

3 方法原理

将待测样品置入一密闭的容器中，通过加热升温使挥发性组分从样品基体中挥发出来，在气液两

相中达到平衡，直接抽取顶空部分气体进行气相色谱分析。以保留时间定性，峰面积定量，采用外标

法定量

高分子材料浸提液中环氧乙烷迁移量 测试谱图：

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 documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 6682 Analytical laboratory water specifications and experimental methods
GB/T 16886.12 Biological evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials
3 Principles of the method
Place the sample to be tested in a closed container, and heat it up to make the volatile components volatilize from the sample matrix.
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: