【英文标准名称】:StandardSpecificationforSelectionofPorousPolyethyleneforUseinSurgicalImplants
【原文标准名称】:外科植入物用多孔聚乙烯的选择
【标准号】:ASTMF755-1999(2005)
【标准状态】:现行
【国别】:
【发布日期】:1999
【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】:F04.11
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:医疗设备;外科植入物;医学科学;聚乙烯;选择;外科学;多孔的
【英文主题词】:plasticsurgicaldevices/applications;polyethylene(PE)plastics/surgicalimplantapplications;polymers-surgicalapplicant
【摘要】:1.1Thisspecificationcoversthepropertiesandtestmethodsforporoushighdensityandultrahighmolecularweightpolyethylenesintendedforuseinsurgicalimplants.Theporouspolyethylenemaybeusedasafreestandingproductorasacoatingonasubstrateinnonloadedapplications..1.2Evaluationoftissueresponsetoaporouspolyethylenemustbecompleted.Guidanceinestablishingbiocompatibilitymaybefoundinthelistofreferences.1.3Clinicalexperienceandanimalstudieshaveshownthattissuewillgrowintotheopenporesofporouspolyethylene.Thetissueingrowthintotheporesmayallowfortheestablishmentofimplantfixation.1.4Thissectiondoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:3P.;A4
【正文语种】: