IEC 60601-2-10 AMD 1-2001 医用电气设备第2-10部分:神经和肌肉刺激器安全专用要求修改1

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【英文标准名称】:Medicalelectricalequipment-Part2-10:Particularrequirementsforthesafetyofnerveandmusclestimulators;Amendment1
【原文标准名称】:医用电气设备第2-10部分:神经和肌肉刺激器安全专用要求修改1
【标准号】:IEC60601-2-10AMD1-2001
【标准状态】:作废
【国别】:国际
【发布日期】:2001-09
【实施或试行日期】:
【发布单位】:国际电工委员会(IX-IEC)
【起草单位】:IEC/SC62D
【标准类型】:()
【标准水平】:()
【中文主题词】:检验;防电击;定义;安全要求;规范(验收);电医学;医疗设备;设备安全;神经;安全工程;电气器具;电疗设备;肌肉;试验;刺激器;安全;医学科学;电气工程;医用电气设备
【英文主题词】:Definitions;Dielectricstrength;Electricappliances;Electricalengineering;Electricalmedicalequipment;Electricalsafety;Electromagneticcompatibility;Electromedicine;Electrotherapyequipment;EMC;Equipmentsafety;Humanmedicine;Inscription;Inspection;Instructionsforuse;Interferencerejections;Marking;Medicalequipment;Medicalsciences;Muscles;Nerves;Output-value;Protectionagainstelectricshocks;Ratedcurrent;Safety;Safetyengineering;Safetyrequirements;Specification(approval);Stimulators;Temperature;Testing;Voltagefluctuations
【摘要】:ThisstandardisMedicalelectricalequipment-Part2-10:Particularrequirementsforthesafetyofnerveandmusclestimulators;Amendment1.
【中国标准分类号】:C39
【国际标准分类号】:11_040_60
【页数】:9P.;A4
【正文语种】:英语


【英文标准名称】:StandardPracticeforTestingtheBiologicalResponsestoParticlesinvivo
【原文标准名称】:测试活体中粒子生物反应的标准规范
【标准号】:ASTMF1904-1998(2008)
【标准状态】:现行
【国别】:美国
【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】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:biocompatibility;biologicalresponse;invivo;interleukins;particles;Biocompatibility;Degradation--surgicaldevices/applications;Growthfactors;Interleukins;Macrophages;Particleanalysis--medical/surgicalapplications
【摘要】:Thispracticeistobeusedtohelpassessthebiocompatibilityofmaterialsusedinmedicaldevices.Itisdesignedtotesttheeffectofparticlesfromthematerialsonthehosttissues.Theappropriatenessofthemethodsshouldbecarefullyconsideredbytheusersincenotallmaterialsorapplicationsneedbetestedbythispractice.Thevalidityofthesestudiesinpredictingthehumanresponseisnotknownatthistimeandstudiessuchasdescribedhereareneeded.AbbreviationUsed:LPS8212;Lipopolysaccharide(endotoxin).LAL8212;Limulusamebocytelysate.PCR8212;Polymerasechainreaction.CD8212;Clusterdifferentiation.HLA8212;Humanleukocyteantigens.1.1Thispracticecoverstheproductionofweardebrisanddegradationproductsfromimplantedmaterialsthatmayleadtoacascadeofbiologicalresponsesresultingindamagetoadjacentandremotetissues.Inordertoascertaintheroleofparticlesinstimulatingsuchresponses,thenatureoftheresponses,andtheconsequencesoftheresponses,establishedprotocolsareneeded.Thisisanemerging,rapidlydevelopingareaandtheinformationgainedfromstandardprotocolsisnecessarytointerpretresponses.Someoftheprocedureslistedheremay,onfurthertesting,notprovetobepredictiveofclinicalresponsestoparticulatedebris.However,onlytheuseofstandardprotocolswillestablishwhichareusefultechniques.Sincetherearemanypossibleandestablishedwaysofdeterminingresponses,asinglestandardprotocolisnotstated.However,thisrecommendedpracticeindicateswhichnecessaryinformationshouldbesuppliedwithtestresults.Forlaboratorieswithoutestablishedprotocols,recommendationsaregivenandindicatedwithan*.1.2Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C04
【国际标准分类号】:11_040_40
【页数】:3P.;A4
【正文语种】:英语


基本信息
标准名称:岩土野外描述规程
替代情况:被YS 5205-2000代替
发布日期:
实施日期:1992-01-01
首发日期:
作废日期:2006-08-21
出版日期:
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