【英文标准名称】:Dentistry-Medicaldevicesfordentistry-Materials
【原文标准名称】:牙科学.牙科用医疗器械.材料
【标准号】:BSEN1641-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-11-30
【实施或试行日期】:2009-11-30
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:生物适应性;生物危害;化学危害;化学性质;临床的;兼容性;组分;制造日期;定义;牙科设备;牙科材料;牙科学;信息;使用说明;加标签;标志;材料性能;材料;医疗器械;医疗设备;医疗产品;医学科学;包装件;物理性能;生产;特性;保护(装置);规范(验收);灭菌;符号;技术文献;测试
【英文主题词】:Biocompatibility;Biologicalhazards;Chemicalhazards;Chemicalproperties;Clinical;Compatibility;Composition;Dataofthemanufacturer;Definitions;Dentalequipment;Dentalmaterials;Dentistry;Information;Instructionsforuse;Labelling;Marking;Materialproperties;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Packages;Physicalproperties;Production;Properties;Protection;Specification(approval);Sterilization(hygiene);Symbols;Technicaldocuments;Testing
【摘要】:ThisEuropeanStandardspecifiesgeneralrequirementsformaterialsusedinthepracticeofdentistryfortherestorationoftheformandfunctionofthedentitionandwhicharemedicaldevices.Forthepurposesofthisstandardthesematerialsaredefinedasrestorativeandorthodonticmaterials.DentalimplantsarespecificallyexcludedanddescribedinEN1642.Thisstandardalsospecifiesgeneralrequirementsformaterialsusedinthepracticeoforthodontics.Thisstandardincludesrequirementsforintendedperformance,designattributes,components,sterilization,packaging,marking,labelling,andinformationsuppliedbythemanufacturer.Testsfordemonstratingcompliancewiththisstandardarecontainedinthelevel3standards,ifappropriate.
【中国标准分类号】:C33
【国际标准分类号】:11_060_10
【页数】:14P.;A4
【正文语种】:英语