【英文标准名称】:StandardSpecificationforPolyethylenePlasticsforMedicalApplications
【原文标准名称】:医疗设备用聚乙烯塑料标准规范
【标准号】:ASTMF639-1998a(2003)
【标准状态】:现行
【国别】:
【发布日期】:1998
【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;使用;聚乙烯;医学科学;塑料
【英文主题词】:plasticsurgicaldevices/applications;polyethylene(PE)plastics-surgicalimplantapplications;polymers-surgicalapplications
【摘要】:1.1Thisspecificationcoverspolyethyleneplastics(asdefinedinTerminologyD883)intendedforuseinmedicaldeviceapplicationsinvolvinghumantissuecontactdevices,shorttermindwellingsof30daysorless,andfluidtransferdevices.Thebiocompatibilityofthesematerialsasaclasshasnotbeenestablished.Biocompatibilitytestsmustbeconductedonthefinalproduct.1.2Thisspecificationisnotapplicabletoultra-highmolecularweightpolyethylenes(UHMWPE)plastics,suchasthoseusedinjointimplants,andsoforth.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:G32
【国际标准分类号】:11_120_01;83_080_20
【页数】:4P.;A4
【正文语种】: