ASTM F640-2007 医疗用辐射不透明度测定的标准试验方法
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【英文标准名称】:StandardTestMethodsforDeterminingRadiopacityforMedicalUse
【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】:ASTMF640-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【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】:(TestMethod)
【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;surgicalapplications;surgicaldevices;surgicalimplants;testmethods;X-ray
【摘要】:Thesemethodsareintendedtodeterminewhetheramaterial,product,orpartofaproducthasthedegreeofradiopacitydesiredforitsapplicationasamedicaldeviceinthehumanbody.Thesemethodsallowforbothqualitativeandquantitativeevaluationindifferentcomparativesituations.1.1ThesetestmethodscoverthedeterminationoftheradiopacityofmaterialsandproductsutilizingX-raybasedtechniques,includingfluoroscopy,angiography,CT(computedtomography)andDEXA,alsoknownasDXA,(dualenergyX-rayabsorptiometry).Theresultsofthesemeasurementsareanindicationofthelikelihoodoflocatingtheproductwithinthehumanbody.1.2TypesofTests-Therearethreemethodsoftestsdescribed,differinginthemethodofdeterminingradiopacity.1.2.1MethodA-Radiopacityis(1)qualitativelydeterminedbyviewingimage(s)ofatestsampleandtheimagebackground,withorwithouttheuseofabodymimic,or(2)quantitativelydeterminedasaspecificdifferenceinopticaldensityorpixelintensitybetweentheimageofatestsampleandtheimagebackground,withorwithouttheuseofabodymimic.1.2.2MethodB-Radiopacityisdeterminedby(1)qualitativelycomparingimage(s)ofatestsampleandauser-definedstandardwithouttheuseofabodymimic,or(2)quantitativelydeterminingthespecificdifferenceinopticaldensityorpixelintensitybetweentheimageofatestsampleandtheimageofauser-definedstandardwithouttheuseofabodymimic.1.2.3MethodC-Radiopacityisdeterminedby(1)qualitativelycomparingimage(s)ofatestsampleandauser-definedstandardwiththeuseofbodymimicor(2)quantitativelydeterminingthespecificdifferenceinopticaldensityorpixelintensitybetweentheimageofatestsampleandtheimageofauser-definedstandardwiththeuseofabodymimic.1.3ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【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】:
【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】:ASTMF640-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【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】:(TestMethod)
【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;surgicalapplications;surgicaldevices;surgicalimplants;testmethods;X-ray
【摘要】:Thesemethodsareintendedtodeterminewhetheramaterial,product,orpartofaproducthasthedegreeofradiopacitydesiredforitsapplicationasamedicaldeviceinthehumanbody.Thesemethodsallowforbothqualitativeandquantitativeevaluationindifferentcomparativesituations.1.1ThesetestmethodscoverthedeterminationoftheradiopacityofmaterialsandproductsutilizingX-raybasedtechniques,includingfluoroscopy,angiography,CT(computedtomography)andDEXA,alsoknownasDXA,(dualenergyX-rayabsorptiometry).Theresultsofthesemeasurementsareanindicationofthelikelihoodoflocatingtheproductwithinthehumanbody.1.2TypesofTests-Therearethreemethodsoftestsdescribed,differinginthemethodofdeterminingradiopacity.1.2.1MethodA-Radiopacityis(1)qualitativelydeterminedbyviewingimage(s)ofatestsampleandtheimagebackground,withorwithouttheuseofabodymimic,or(2)quantitativelydeterminedasaspecificdifferenceinopticaldensityorpixelintensitybetweentheimageofatestsampleandtheimagebackground,withorwithouttheuseofabodymimic.1.2.2MethodB-Radiopacityisdeterminedby(1)qualitativelycomparingimage(s)ofatestsampleandauser-definedstandardwithouttheuseofabodymimic,or(2)quantitativelydeterminingthespecificdifferenceinopticaldensityorpixelintensitybetweentheimageofatestsampleandtheimageofauser-definedstandardwithouttheuseofabodymimic.1.2.3MethodC-Radiopacityisdeterminedby(1)qualitativelycomparingimage(s)ofatestsampleandauser-definedstandardwiththeuseofbodymimicor(2)quantitativelydeterminingthespecificdifferenceinopticaldensityorpixelintensitybetweentheimageofatestsampleandtheimageofauser-definedstandardwiththeuseofabodymimic.1.3ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【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】:
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