ASTM F639-2009 医疗设备用聚乙烯塑料的标准规范

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【英文标准名称】:StandardSpecificationforPolyethylenePlasticsforMedicalApplications
【原文标准名称】:医疗设备用聚乙烯塑料的标准规范
【标准号】:ASTMF639-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【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】:
【英文主题词】:plasticsurgicaldevices/applications;polyethylene(PE)plastics&x2014;surgicalimplantapplications;polymers&x2014;surgicalapplications;Plasticsurgicaldevices/applications--specifications;
【摘要】:SignificanceTopX1.2.1Concentrationsoftracemetalsaremeasuredasextractsinsimulatedbodyfluids.Themetalx2019;sconcentrationinextractsisbasedonthesurfaceareaoftheplasticextractedfromwhichthetotalamountofmetaldeliverabletothepatientmaybeestimated.1.1Thisspecificationcoverspolyethyleneplastics(asdefinedinTerminologyD883)intendedforuseinmedicaldeviceapplicationsinvolvinghumantissuecontactdevices,short-termindwellingsof30daysorless,andfluidtransferdevices.Thebiocompatibilityofthesematerialsasaclasshasnotbeenestablished.Biocompatibilitytestsmustbeconductedonthefinalproduct.1.2Thisspecificationisnotapplicabletoultra-highmolecularweightpolyethylenes(UHMWPE)plastics,suchasthoseusedinjointimplants,andsoforth.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.X1.1.1Thispracticecoverstheanalysisofextractablemetalsfromplasticsintendedforuseinmedicaldeviceapplication.X1.1.2Formulatedrawmaterialsorfinishedproductsmaybeused.
【中国标准分类号】:C48
【国际标准分类号】:83_080_20
【页数】:3P.;A4
【正文语种】:英语