首页 馆藏资源 舆情信息 标准服务 科研活动 关于我们
现行 ASTM F2381-19
到馆提醒
收藏跟踪
购买正版
Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy 用红外光谱法评估外科植入物用辐照超高分子量聚乙烯制备模板中反式乙烯产率的标准试验方法
发布日期: 2019-10-01
1.1 本试验方法描述了医用植入物用超高分子量聚乙烯(UHMWPE)中反式乙烯基数量的测量。材料通过红外光谱进行分析。 1.2 本测试方法基于指南 F2102页 . 1.3 其他文献报告已经证明了红外方法的适用性。这是一种特殊的方法,使用以1370cm为中心的C-H吸收强度(面积) -1 为了使样品厚度正常化,将通过根据实践进行的实验室间研究(ILS)进行验证 E691 . 1.4 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.5 本标准并非旨在解决与其使用相关的所有安全问题(如有)。本标准的用户有责任在使用前制定适当的安全、健康和环境实践,并确定监管限制的适用性。 1.6 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 已发表的文献表明,在辐射治疗期间发生的辐射分解反应的产率随着辐射剂量水平的增加而增加。这些反应产物的测量可以用作内剂量计。 4.2 反式乙烯不饱和是在电离处理过程中通过提取氢分子形成的,在较小程度上是通过驻留在同一链上的两个相邻烷基自由基的复合形成的。 4.3 之前的工作生成了反式乙烯吸收面积随吸收辐射剂量变化的校准曲线,得出了两个γ的线性关系- 电子束辐照聚乙烯。 4.4 假设已知所用特定材料和辐射条件的校准曲线(TVI与辐射剂量水平),该数据可用于确定作为位置函数的接收剂量,并可用于确定辐照聚乙烯中剂量水平的均匀性。
1.1 This test method describes the measurement of the number of trans-vinylene groups in ultra-high molecular weight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy. 1.2 This test method is based on Guide F2102 . 1.3 The applicability of the infrared method has been demonstrated in other literature reports. This particular method, using the intensity (area) of the C-H absorption centered at 1370 cm -1 to normalize for the sample’s thickness, will be validated by an Interlaboratory Study (ILS) conducted according to Practice E691 . 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 Published literature shows that the yield of radiolytic reactions that occur during radiation treatment increases with radiation dose level. Measurement of the products of these reactions can be used as an internal dosimeter. 4.2 Trans-vinylene unsaturations are formed during ionization treatment by abstraction of a hydrogen molecule, and to a lesser extent by the recombination of two adjacent alkyl free radicals that reside on the same chain. 4.3 Previous work generated calibration curves of trans-vinylene absorption area as a function of absorbed radiation dose, yielding a linear relationship for both gamma- and electron beam-irradiated polyethylene. 4.4 This data can be used to determine received dose as a function of position, assuming a calibration curve (TVI versus radiation dose level) is known for the particular material and radiation conditions used, and can be used to determine uniformity of dose level in irradiated polyethylene.
分类信息
关联关系
研制信息
归口单位: F04.15
相似标准/计划/法规