ANSI/ADA 57-2000 牙髓填充材料

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【英文标准名称】:Medicalelectricalequipment-Part1-2:generalrequirementsforsafety-Collateralstandard:electromagnéticcompatibility-Requirementsandtests.
【原文标准名称】:医用电气设备.第1-2部分:安全通用要求.附带标准:电磁兼容性.要求和试验
【标准号】:NFC74-012/A1-2006
【标准状态】:现行
【国别】:法国
【发布日期】:2006-08-01
【实施或试行日期】:2006-08-20
【发布单位】:法国标准化协会(FR-AFNOR)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:事故预防;麻醉学;防护等级;分类;间隙;色码;制造日期;口述;定义;尺寸;文献工作;接地导线;接地;电气器具;(电网)电源;电气设备;电气工程;医用电气设备;电磁兼容性;电医学;静电学;企业;环境条件;设备;设备安全;防爆;图形符号;高频;高频外科学;冲击试验器;信息;绝缘;干扰抑制;干扰;干扰辐射;漏电路径;文字书写;表;低频;作标记;测量;医疗设备;医学科学;医疗技术学;保护覆盖层;合格试验;辐射防护;射频设备;安全;安全装置;安全工程;安全要求;规范(验收);材料强度;调查;符号;温度;试验设备;试验;试验电压;变压器
【英文主题词】:Accidentprevention;Anaesthesiology;Classesofprotection;Classification;Clearances;Colourcodes;Dataofthemanufacturer;Declarations;Definition;Definitions;Dimensions;Earthconductors;Earthing;Electricappliances;Electricmains;Electricalappliances;Electricalengineering;Electricalmedicalequipment;Electromagneticcompatibility;Electromedicine;Electrostatics;EMC;Enterprises;Environmentalconditions;Equipment;Equipmentsafety;Explosionprotection;Graphicsymbols;Highfrequencies;Highfrequencysurgery;Impacttesters;Information;Insulations;Interferencerejections;Interferences;Interferingemissions;Leakagepaths;Letterings;Lists;Lowfrequencies;Marking;Measurement;Medicalequipment;Medicalsciences;Medicaltechnology;Operationalinstructions;Protectioncoverings;Qualificationtests;Radiationprotection;Radiofrequencyapparatus;Safety;Safetydevices;Safetyengineering;Safetyrequirements;Specification(approval);Strengthofmaterials;Surveys;Symbols;Temperature;Testequipment;Testing;Testingvoltages;Transformers
【摘要】:
【中国标准分类号】:L06
【国际标准分类号】:11_040_01;33_100_01
【页数】:25P.;A4
【正文语种】:其他


【英文标准名称】:Biologicalevaluationofmedicaldevices-Testsforlocaleffectsafterimplantation
【原文标准名称】:医疗设备的生物评价.植入后局部效果试验
【标准号】:BSENISO10993-6-2007
【标准状态】:作废
【国别】:英国
【发布日期】:2007-05-31
【实施或试行日期】:2007-05-31
【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】:生物测定;生物适应性;生物分析和试验;生物试验;兼容性;牙科设备;牙科材料;牙科学;测定;精密机械;植入试验;外科植入物;材料;医疗设备;医疗器械;医疗产品;医学科学;方法;外科学;外科设备;测试
【英文主题词】:Bioassay;Biocompatibility;Biological;Biologicalanalysisandtesting;Biologicalhazards;Biologicaltests;Ceramics;Compatibility;Definitions;Dentalequipment;Dentalmaterials;Dentistry;Determination;Evaluations;Experimentalanimals;Fabrics;Finemechanics;Histology;Implantationtest;Implants(surgical);Macroscopic;Materials;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalproducts;Medicalsciences;Methods;Muscles;Observation;Polymers;Preparation(medical);Principle;Production;Reaction;Samples;Scope;Solids;Surgery;Surgicalequipment;Surgicalimplants;Taking-out;Testduration;Testpieces;Testing
【摘要】:ISO10993-6:2007specifiestestmethodsfortheassessmentofthelocaleffectsafterimplantationofbiomaterialsintendedforuseinmedicaldevices.ISO10993-6:2007appliestomaterialsthatare:solidandnon-biodegradable;degradableand/orresorbable;non-solid,suchasporousmaterials,liquids,pastesandparticulates.ISO10993-6:2007mayalsobeappliedtomedicaldevicesthatareintendedtobeusedtopicallyinclinicalindicationswherethesurfaceorliningmayhavebeenbreached,inordertoevaluatelocaltissueresponses.ThispartofISO10993doesnotdealwithsystemictoxicity,carcinogenicity,teratogenicityormutagenicity.However,thelong-termimplantationstudiesintendedforevaluationoflocalbiologicaleffectsmayprovideinsightintosomeoftheseproperties.SystemictoxicitystudiesconductedbyimplantationmaysatisfytherequirementsofISO10993-6:2007.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:34P;A4
【正文语种】:英语