IEC6060112012医用电气设备基本安全和基本性能的要求

IEC60601-1Edition3.12012-08INTERNATIONALSTANDARDMedicalelectricalequipment–Part1:GeneralrequirementsforbasicsafetyandessentialperformanceIEC60601-1:2005+A1:2012(E)®colourinside--`,,`,```,`,,`,`,,`,,,,`,`,,,-`-`,,`,,`,`,,`---THISPUBLICATIONISCOPYRIGHTPROTECTEDCopyright©2012IEC,Geneva,SwitzerlandAllrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedinanyformorbyanymeans,electronicormechanical,includingphotocopyingandmicrofilm,withoutpermissioninwritingfromeitherIECorIEC'smemberNationalCommitteeinthecountryoftherequester.IfyouhaveanyquestionsaboutIECcopyrightorhaveanenquiryaboutobtainingadditionalrightstothispublication,pleasecontacttheaddressbeloworyourlocalIECmemberNationalCommitteeforfurtherinformation.IECCentralOfficeTel.:[phone],ruedeVarembéFax:[e-mail](IEC)istheleadingglobalorganizationthatpreparesandpublishesInternationalStandardsforallelectrical,electronicandrelatedtechnologies.AboutIECpublicationsThetechnicalcontentofIECpublicationsiskeptunderconstantreviewbytheIEC.Pleasemakesurethatyouhavethelatestedition,acorrigendaoranamendmentmighthavebeenpublished.Usefullinks:IECpublicationssearch-(referencenumber,text,technicalcommittee,…).Italsogivesinformationonprojects,replacedandwithdrawnpublications.IECJustPublished-webstore.iec.ch/justpublishedStayuptodateonallnewIECpublications.JustPublisheddetailsallnewpublicationsreleased.Availableon-lineandalsoonceamonthbyemail.Electropedia-(IEV)on-line.CustomerServiceCentre-webstore.iec.ch/cscIfyouwishtogiveusyourfeedbackonthispublicationorneedfurtherassistance,pleasecontacttheCustomerServiceCentre:[e-mail].--`,,`,```,`,,`,`,,`,,,,`,`,,,-`-`,,`,,`,`,,`---IEC60601-1Edition3.12012-08INTERNATIONALSTANDARDMedicalelectricalequipment–Part1:GeneralrequirementsforbasicsafetyandessentialperformanceINTERNATIONALELECTROTECHNICALCOMMISSIONCWICS11.040PRICECODEISBN978-2-8322-0331-6®RegisteredtrademarkoftheInternationalElectrotechnicalCommission®Warning!Makesurethatyouobtainedthispublicationfromanauthorizeddistributor.colourinside--`,,`,```,`,,`,`,,`,,,,`,`,,,-`-`,,`,,`,`,,`---–2–60601-1”IEC:2005+A1:2012(E)CONTENTSFOREWORD.........................................................................................................................11INTRODUCTION...................................................................................................................141Scope,objectandrelatedstandards...............................................................................171.1*Scope.................................................................................................................171.2Object...................................................................................................................171.3*Collateralstandards............................................................................................171.4*Particularstandards............................................................................................182*Normativereferences...................................................................................................183*Terminologyanddefinitions.........................................................................................184Generalrequirements.....................................................................................................424.1*ConditionsforapplicationtoMEEQUIPMENTorMESYSTEMS..................................424.2*RISKMANAGEMENTPROCESSforMEEQUIPMENTorMESYSTEMS..............................434.3*ESSENTIALPERFORMANCE.....................................................................................434.4*EXPECTEDSERVICELIFE........................................................................................464.5*EquivalentsafetyforMEEQUIPMENTorMESYSTEMS*AlternativeRISKCONTROLmeasuresortestmethodsforMEEQUIPMENTorMESYSTEMS...........................................................................................................474.6*MEEQUIPMENTorMESYSTEMpartsthatcontactthePATIENT.................................474.7*SINGLEFAULTCONDITIONforMEEQUIPMENT...........................................................474.8*ComponentsofMEEQUIPMENT.............................................................................484.9*UseofCOMPONENTSWITHHIGH-INTEGRITYCHARACTERISTICSinMEEQUIPMENT.......494.10*Powersupply......................................................................................................504.11Powerinput...........................................................................................................505*Gen