YBB 0024-2003 121℃内表面耐水性测定法和分级(试行)

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基本信息
标准名称:121℃内表面耐水性测定法和分级(试行)
英文名称:121℃ Neibiaomian Naishuixing Cedingfa He Fenji Tests and classification for hydrolytic resistance of interior surfaces
中标分类: 医药、卫生、劳动保护 >> 医药、卫生、劳动保护综合 >> 标志、包装、运输、贮存
ICS分类: 医药卫生技术 >> 医学科学和保健装置综合
发布日期:2003-10-28
实施日期:2003-10-27
首发日期:
作废日期:
出版日期:
页数:4页
适用范围

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所属分类: 医药 卫生 劳动保护 医药 卫生 劳动保护综合 标志 包装 运输 贮存 医药卫生技术 医学科学和保健装置综合
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【英文标准名称】:Injectioncontainersandaccessories-Part4:Injectionvialsmadeofmouldedglass(ISO8362-4:2011);GermanversionENISO8362-4:2011
【原文标准名称】:注射容器及附件.第4部分:模压玻璃制成的注射液瓶(ISO8362-4-2011).德文版ENISO8362-4-2011
【标准号】:DINENISO8362-4-2011
【标准状态】:现行
【国别】:德国
【发布日期】:2011-12
【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】:
【英文主题词】:Alkaliglass;Blow-mouldedglass;Borosilicateglass;Bottles;Containers;Design;Designations;Dimensions;Flasks;Glass;Glassbottles;Glasscontainers;Glassware;Injectionbottles;Injectioncontainers;Injectioninstruments;Injectionpreparations;Injections;Marking;Materials;Medicalequipment;Medicalsciences;Medicaltechnology;Parenteralinfusionequipment;Performancerequirements;Shape;Specification(approval);Tolerances(measurement);Tubularshape;Volume
【摘要】:
【中国标准分类号】:C31
【国际标准分类号】:11_040_20
【页数】:15P;A4
【正文语种】:德语


【英文标准名称】:Medicalelectricalequipment.Particularrequirementsforbasicsafetyandessentialperformanceofpulseoximeterequipment
【原文标准名称】:医用电气设备.对脉搏血氧计设备基本安全和基本性能的特殊要求
【标准号】:BSENISO80601-2-61-2011
【标准状态】:现行
【国别】:英国
【发布日期】:2011-08-31
【实施或试行日期】:2011-08-31
【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】:
【英文主题词】:Alarm;Alpharadiation;Anaestheticequipment;Assembling;Betaradiation;Biocompatibility;Bloodcounts;Bodies;Breathingequipment;Chargings;Chemicalanalysisandtesting;Clamps;Cleaning;Compatibility;Components;Connections;Continuouscurrent;Corners;Covers;Defects;Definitions;Determinations;Dielectricstrength;Discharge;Disinfections;Earthconductors;Earthingconductorterminations;Edge;Electricpowersystems;Electrical;Electricalengineering;Electricalmedicalequipment;Electricalsafety;Electromagneticcompatibility;Electromedicine;Electrostatics;EMC;Enclosures;Energy;Environmentalconditions;Environmentaltesting;Equipmentsafety;Fireprevention;Gamma-radiation;Haemoglobin;Haemoglobincontent;Hydraulics;Infraredradiation;Inputcurrent;Interruptions;Laserbeams;Layout;Limitations;Liquids;Luminousradiation;Mass;Measuringinstruments;Mechanics;Medicaldevices;Medicalequipment;Medicalsciences;Medicaltechnology;Moisture;Neutronradiation;Noise;Outlets;Overflows;Oximeters;Oximetry;Oxygensaturation;Paper;Patientauxiliarycurrent;Performancerequirements;Pneumatics;Potentialequalization;Powerconsumption;Precision;Pressure;Pressurevessels;Protectionagainstelectricshocks;Protectioncoverings;Protectivedevices;Protectivemeasures;Pulse;Pulseoximeters;Radiationprotection;Safety;Safetyengineering;Safetyrequirements;Saturation;Separation;Signals;Soundenergy;Specification(approval);Stability;Sterilization(hygiene);Strengthofmaterials;Stress;Surfaces;Systemearthing;Temperature;Testing;Ultrasonics;Ultravioletradiation;Use;Vibrations;Workingdata;X-rays
【摘要】:Subclause1.1ofThegeneralstandardisreplacedby:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofPULSEOXIMETEREQUIPMENTintendedforuseonhumans,hereafterreferredtoasMEEQUIPMENT.ThisincludesanypartnecessaryforNORMALUSE,includingthePULSEOXIMETERMONITOR,PULSEOXIMETERPROBE,andPROBECABLEEXTENDER.TheserequirementsalsoapplytoPULSEOXIMETEREQUIPMENT,includingPULSEOXIMETERMONITORS,PULSEOXIMETERPROBESandPROBECABLEEXTENDERS,whichhavebeenREPROCESSED.TheintendeduseofPULSEOXIMETEREQUIPMENTincludes,butisnotlimitedto,theestimationofarterialoxygenhaemoglobinsaturationandpulserateofPATIENTSinprofessionalhealthcareinstitutionsaswellasPATIENTSintheHOMEHEALTHCAREENVIRONMENT.ThisInternationalStandardisnotapplicabletoPULSEOXIMETEREQUIPMENTintendedforuseinlaboratoryresearchapplicationsnortooximetersthatrequireabloodsamplefromthePATIENT.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin201.11andin7.2.13and8.4.1ofthegeneralstandard.NOTESeealso4.2ofthegeneralstandard.ThisstandardcanalsobeappliedtoPULSEOXIMETEREQUIPMENTandtheirACCESSORIESusedforcompensationoralleviationofdisease,injuryordisability.ThisInternationalStandardisnotapplicabletoPULSEOXIMETEREQUIPMENTintendedsolelyforfoetaluse.ThisInternationalStandardisnotapplicabletoremoteorslave(secondary)devicesthatdisplaySpO2valuesthatarelocatedoutsideofthePATIENTENVIRONMENT.
【中国标准分类号】:C38
【国际标准分类号】:11_040_55
【页数】:98P.;A4
【正文语种】:英语