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【英文标准名称】:Dentistry-Medicaldevicesfordentistry-Materials
【原文标准名称】:牙科学.牙科用医疗装置.材料
【标准号】:BSEN1641-2004
【标准状态】:作废
【国别】:英国
【发布日期】:2004-06-14
【实施或试行日期】:2004-06-14
【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】:材料;生产;作标记;灭菌;信息;加标签;物理性能;医疗产品;包装件;牙科材料;牙科学;化学性质;制造日期;定义;使用说明;规范(验收);医疗设备;试验;牙科设备;材料性能;可混用性;特性;医学科学;技术文献
【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.Forthepurposesofthisstandardthesematerialsaredefinedasrestorativematerials.DentalimplantsarespecificallyexcludedanddescribedinEN1642.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