DIN EN ISO 7153-1-2001 外科仪器.金属材料.第1部分:不锈钢

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【英文标准名称】:Surgicalinstruments-Metallicmaterials-Part1:Stainlesssteel(ISO7153-1:1991,includingAmendment1:1999);EnglishversionofDINENISO7153-1:2001-02
【原文标准名称】:外科仪器.金属材料.第1部分:不锈钢
【标准号】:DINENISO7153-1-2001
【标准状态】:现行
【国别】:德国
【发布日期】:2001-02
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:医疗器械;化学成分;外科学;材料;医疗设备;调查;钢的等级;钢;牙科器械;选择;外科设备;金属的;不锈钢;牙科设备
【英文主题词】:Chemicalcomposition;Dentalequipment;Dentalinstruments;Materials;Medicalequipment;Medicalinstruments;Metallic;Selection;Stainlesssteels;Steelgrades;Steels;Surgery;Surgicalequipment;Surveys
【摘要】:ThispartofISO7153containsasurveyandaselectionofstainlesssteelsavailableforuseinthemanufactureofsurgical,dentalandspecificinstrumentsfororthopaedicsurgery.NOTE1Whenselectingthegradeofsteelandtheshape,dimensionsanddeliveryconditionsoftherawmaterialformanufacturingsurgicalinstruments,itisnecessarytotakeintoaccountfactors,suchasthedesignoftheinstrumentortheproductionfacilitiesofthemanufacturer,thatarenotcoveredbythispartofISO7153.Forthisreason,itisnotintended,norisitpossible,thattheinformationgiveninthispartofISO7153shouldremovethedecision-makingresponsibilityfromtheinstrumentmanufacturerforselectinganappropriaterawproductwithsuitableproperties;norisitintendedtoprecludetheuseofothertypesofsteelinthemanufactureofinstruments,suchastheuseofcarbonsteelforcuttinginstruments.InternationalStandardsforsurgicalinstruments,whenpublished,shouldbeobservedwhenmakingthisdecisionastheymaycontainadditionalornewinformationtobetakenintoaccountwhenselectingappropriatesteelgrades.
【中国标准分类号】:C30
【国际标准分类号】:11_040_30;77_140_20
【页数】:8P.;A4
【正文语种】:英语


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【英文标准名称】:Medicalelectricalequipment.Particularrequirementsforthebasicsafetyandessentialperformanceofinfantincubators
【原文标准名称】:医疗电气设备.婴儿保温箱基本安全性和主要性能的详细要求
【标准号】:BSEN60601-2-19-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-07-31
【实施或试行日期】:2009-07-31
【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】:准确度;警报系统;分类;分类系统;控制装置;定义(术语);名称与符号;测定;电气设备;电气工程;电气设施;医用电气设备;电气保护设备;电气安全性;电气测试;电磁兼容性;电磁装置;电医学;电子设备及元件;电磁兼容性(EMC);环境条件;环境测试;防火;火险;防火安全性;危害;医院设备;识别方法;保温箱;恒温箱;保育箱(婴儿);批注;使用说明书;作标记;机械安全性;机械测试;医疗器械;医疗设备;医疗技术学;性能测试;防护电气设备;防电击;保护措施;辐射防护;减震系统(防护);安全性;安全装置;安全工程;安全措施;安全性要求;声强;规范(验收);稳定性;材料强度;监督(认可);温度;温度控制器;温度稳定性;测试;测试条件;温度差异;通风
【英文主题词】:Accuracy;Alarmsystems;Classification;Classificationsystems;Controldevices;Definitions;Designations;Determinations;Electricalappliances;Electricalengineering;Electricalequipment;Electricalmedicalequipment;Electricalprotectionequipment;Electricalsafety;Electricaltesting;Electromagneticcompatibility;Electromagneticdevices;Electromedicine;Electronicequipmentandcomponents;EMC;Environmentalconditions;Environmentaltesting;Fireprevention;Firerisks;Firesafety;Hazards;Hospitalequipment;Identificationmethods;Incubator;Incubators;Incubators(infant);Inscription;Instructionsforuse;Marking;Mechanicalsafety;Mechanicaltesting;Medicaldevices;Medicalequipment;Medicaltechnology;Performancetesting;Protectedelectricalequipment;Protectionagainstelectricshocks;Protectivemeasures;Radiationprotection;Restraintsystems(protective);Safety;Safetydevices;Safetyengineering;Safetymeasures;Safetyrequirements;Soundintensity;Specification(approval);Stability;Strengthofmaterials;Surveillance(approval);Temperature;Temperaturecontrollers;Temperaturestability;Testing;Testingconditions;Uniformityoftemperature;Ventilations
【摘要】:Clause1ofthegeneralstandardapplies,exceptasfollows:Replacement:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofINFANTINCUBATORS,asdefinedin201.3.209ofthisstandard,alsoreferredtoasMEEQUIPMENT.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofthegeneralstandard.ThisparticularstandardspecifiessafetyrequirementsforINFANTINCUBATORSbutalternatemethodsofcompliancewithaspecificclausebydemonstratingequivalentsafetywillnotbejudgedasnon-compliantiftheMANUFACTURERhasdemonstratedinhisRISKMANAGEMENTFILEthattheRISKpresentedbytheHAZARDhasbeenfoundtobeofanacceptablelevelwhenweighedagainstthebenefitoftreatmentfromthedevice.Thisparticularstandarddoesnotapplyto:–devicessupplyingheatviaBLANKETS,PADSorMATTRESSESinmedicaluse;forinformationseeIEC80601-2-35;–INFANTRADIANTWARMERS;forinformation,seeIEC60601-2-21;–INFANTTRANSPORTINCUBATORS,forinformation,seeIEC60601-2-20;–INFANTPHOTOTHERAPYEQUIPMENT,forinformationseeIEC60601-2-50
【中国标准分类号】:C47
【国际标准分类号】:11_040_10
【页数】:46P.;A4
【正文语种】:英语


【英文标准名称】:Temporaryworksequipment-Part1:scaffolds-Performancerequirementsandgeneraldesign.
【原文标准名称】:临时工作设备.第1部分:脚手架.性能要求和一般设计
【标准号】:NFP93-501-1-2004
【标准状态】:现行
【国别】:法国
【发布日期】:2004-08-01
【实施或试行日期】:2004-08-05
【发布单位】:法国标准化协会(AFNOR)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:规范(验收);建筑;宽度;定义;尺寸;效应;活荷载;脚手架;载荷分布;通路;说明书;元部件;工作场所安全;安全要求;性能要求;尺寸选定;手册;稳定性;风荷载;工作脚手架;吊式脚手架;职业安全;事故预防;材料;安全工程;验证;负荷
【英文主题词】:
【摘要】:
【中国标准分类号】:P96
【国际标准分类号】:91_220
【页数】:46P;A4
【正文语种】:其他