ASTM F1828-1997(2006) 输尿管展伸的标准规范

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【英文标准名称】:StandardSpecificationforUreteralStents
【原文标准名称】:输尿管展伸的标准规范
【标准号】:ASTMF1828-1997(2006)
【标准状态】:现行
【国别】:
【发布日期】:1997
【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】:F04.34
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:内在装置;输尿管展伸;高聚物;试验方法;泌尿科学
【英文主题词】:indwellingdevices;polymers;testmethods;ureteralstents;urology
【摘要】:1.1Thisspecificationcoverstherefereetestmethodsforevaluatingtheperformancecharacteristicsofasingle-useureteralstentwithretainingmeansatbothends,duringshorttermusefordrainageofurinefromthekidneytothebladder.Thesestentsaretypicallyavailableindiametersof3.7Frto14.0Fr,andlengthsof8cmto30cm,andaremadeofsilicone,polyurethane,andotherpolymers.Theyareprovidednon-sterileforsterilizationandsterileforsingle-use.1.2ExclusionsLong-termindwellingusage(over30days)isencounteredwiththisproduct,butnotcommonly,andisthereforeconsideredanexceptiontothisspecification.Similarly,theuseofureteralstentsfornon-ureteralapplicationssuchasnephrostomyandileostomyisexcludedfromthescopeofthisspecification.Non-sterileureteralstentsarealsoexcludedduetothevariabilityofhospitalsterilizationequipmentandprocessesandtheresultingeffectsonureteralstentcharacteristics.1.3Thefollowingprecautionarystatementpertainsonlytothetestmethodportion,Section,ofthisspecification:Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C18
【国际标准分类号】:11_040_40
【页数】:6P.;A4
【正文语种】: