ASTM F640-2012 医疗用辐射不透明度测定的标准试验方法
【英文标准名称】: Standard Test Methods for Determining Radiopacity for Medical Use 【原文标准名称】: 医疗用辐射不透明度测定的标准试验方法 【标准号】: ASTM F640-2012 【标准状态】: 现行 【国别】: 【发布日期】: 2012 【实施或试行日期】: 【发布单位】: 美国材料与试验协会(US-ASTM)【起草单位】: F04.15【标准类型】: (Test Method)【标准水平】: ()【中文主题词】: 实验室医学;医疗设备;医学科学;塑料;射线照片;测试【英文主题词】: implants; radiopacity; surgical applications; surgical devices; surgical implants; test methods; X-ray【摘要】: These methods are intended to determine whether a material, product, or part of a product has the degree of radiopacity desired for its application as a medical device in the human body. These methods allow for both qualitative and quantitative evaluation in different comparative situations.1.1 These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography) and DEXA, also known as DXA, (dual energy X-ray absorptiometry). The results of these measurements are an indication of the likelihood of locating the product within the human body.1.2 Types of Tests - There are three methods of tests described, differing in the method of determining radiopacity.1.2.1 Method A - Radiopacity is (1) qualitatively determined by viewing image(s) of a test sample and the image background, with or without the use of a body mimic, or ( 2) quantitatively determined as a specific difference in optical density or pixel intensity between the image of a test sample and the image background, with or without the use of a body mimic.1.2.2 Method B - Radiopacity is determined by (1) qualitatively comparing image(s) of a test sample and a user-defined standard without the use of a body mimic, or (2) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test sample and the image of a user-defined standard without the use of a body mimic.1.2.3 Method C - Radiopacity is determined by (1) qualitatively comparing image(s) of a test sample and a user-defined standard with the use of body mimic or (2) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test sample and the image of a user-defined standard with the use of a body mimic.1.3 The values stated in SI units are to be regarded as the standard.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 and health practices and determine the applicability of regulatory limitations prior to use.【中国标准分类号】: G32;C04【国际标准分类号】: 11_120_01 ; 83_080_01【页数】: 4P.;A4【正文语种】:版主 这个标准没上传附件么？ 太想要这个来学习了，真是找了好久才找到这个论坛有这个标准啊 求附件啊！！！！！！！:dizzy::dizzy::dizzy::dizzy::dizzy::dizzy:
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