IEC 60601181996.docx

IEC 60601181996.docx

《IEC 60601181996.docx》由会员分享，可在线阅读，更多相关《IEC 60601181996.docx（48页珍藏版）》请在冰点文库上搜索。

IEC60601181996

STRATEGICDEVICECOMPLIANCESERVICES

GlobalSafety,RegulatoryandStandardsComplianceServices

IEC60601-1-8:

Medicalelectricalequipment

Generalrequirementsforsafety–Forcollateralstandard:

Generalrequirements,testsandguidanceforalarmsystemsinmedicalelectricalequipmentandmedicalelectricalsystems

IEC60601-1-8Edition1vs.Edition2

2ndEdition

1stEdition

Clause

Requirement

Clause

Equivalence

Level

Compliance/Comment

4

IfthemanufacturerchoosesasameansofriskcontroltohavetheMEequipmentormesystemnotifytheoperatorthatahazardoussituationcanexist,thenthemeequipmentormesystemshallincludeanalarmsystemcomplyingwiththiscollateralstandardforthatpurpose.Seealso12.3ofthegeneralstandard.

--

None（noexplicitequivalencein1stEdition,byimplicationonly）

5.2

accompanyingdocumentsmeetrequirementslistedinTableB.2

6.8.1

Identical

5.2.1

Theinstructionsforuseprovideandindicatethefollowing:

-anoverviewofthealarmsystem,includingalistinganddescriptionofeverypossiblealarmconditionandasummaryofhowitisdetermined

6.8.2

Identical

-anydelayinherentinthedeterminationofanalarmcondition

6.8.2

Identical

-theoperator’sposition,andhowandwhentoverifythefunctionalityofthealarmsystem

6.8.2

Identical

Theinstructionsforusecautionagainstsettingalarmlimitstoextremevaluesthatcanrenderthealarmsystemuseless

6.8.2

Identical

TheinstructionsforusemeettherequirementslistedinTableBB.3

6.8.2

Identical

5.2.2

ThetechnicaldescriptionmeetstherequirementslistedinTableB.4

6.8.3

Identical

6.1.

Thealarmsignalsandconditionsaregroupedintophysiologicalalarmconditions,technicalalarmconditionsorotheralarmconditionstheseshallbedisclosedintheIFU.

201.1.1

Identical

6.1.2

Alarmconditionsareassignedtooneormoreofthefollowingpriorities:

highpriority,mediumpriorityorlowpriority

201.1.2

Identical

Theassignmentofprioritiesispartoftheriskmanagementprocess（giveninISO14971）andisbasedonTable1

201.1.2

Identical

Theinstructionsforusedisclosethepriorityofeachalarmcondition

201.1.2

Identical

6.2

Anintelligentalarmsystemisprovidedandtheinstructionsforuseincludeanoverviewofhowthealarmsystem:

201.2

Identical

a）determinesanalarmconditiononthebasisoftime,weightings,multiplevariables,orotheradvanceprocessing

201.2

Identical

b）generatesalarmsignalsfortwoormorealarmconditionsofequalpriority

201.2

Identical

c）changesthepreviously-assignedpriorityorrelativeprioritizationofaparticularalarmcondition

201.2

Identical

d）changesthealarmsignalgenerationdelayoralarmconditiondelay

201.2

Identical

e）changesthecharacteristicsofthegeneratedalarmsignals

201.2

Identical

6.3.1

Eachalarmconditioncausesthegenerationofvisualalarmsignals

201.3.1

Identical

Riskassessmentshalldeterminewhethertheintendeduseenvironmentrequiresadditionalalarmsignals

201.3.1

Identical

6.3.2.1

Alarmsystemsgeneratevisualalarmsignalstoindicatethepresenceofalarmconditions,theirpriorityandeachspecificalarmconditionshallbemadeclear.

201.3.2.1

Identical

6.3.2.2

Visualindicatorsprovidedtotheoperatorifrequiredtoidentifytheequipmentorpartoftheequipmentthatrequiresoperatorresponseorawareness

201.3.2.2

Similar（“ifrequired”isnewand2requirementsrelatedtotextnexttosignalwereeliminated）

a）duringmultiplealarmconditions,atleastonevisualalarmsignalindicatesthepriorityofthehighestpriorityalarmcondition

201.3.2.2

Identical

b）atleastonevisualsignalthatanalarmconditionexistsshallbeabletobeperceivedcorrectlyatadistanceof4mfromthealarmsystem

201.3.2.2

Identical

ThealarmindicatorlightsorgraphicalsimulationsofanindicatorlightscomplywiththecolourandflashingrequirementsgiveninTable2

201.3.2.2

Identical

Atleastonevisualalarmsignalisprovidedthatidentifiesthespecificalarmconditionanditspriority.

201.3.2.2

Identical

Thesignalisperceivedcorrectlyatadistanceof1mfromtheequipmentorpartoftheequipmentorfromtheoperator’sposition

201.3.2.2

Identical

Thevisualindicationmaybetextbesideanindicatorlightoronadisplay

201.3.2.2

Identical

ThepresenceofanalarmconditionshouldbevisuallyindicatedwithsymbolIEC60417-5307

201.3.2.2

Identical

Theprioritymaybeindicatedbytheadditionofone,twoorthreeoptionalelements（1,2or3“!

”）

201.3.2.2

Identical

Whenmultiplealarmconditionsoccuratthesametime,eachindividualalarmconditionisvisuallyindicated,eitherautomaticallyorbyoperatoractionORIfanintelligentalarmsystemisprovidedthatpreventsalowerinternalrankalarmconditionfromgeneratingalarmsignalswhenahigherinternalrankalarmconditionisgeneratingorhasrecentlygeneratedalarmsignals

201.3.2.2

Identical

Visualinformationsignalsarecorrectlyperceivedasdifferentfromvisualalarmsignalsatadistanceof1mfromthealarmsystemorfromtheoperator’sposition

201.3.2.2

Identical

6.3.3.1

Thealarmsystemprovidedwithauditoryalarmsignalshasatleastonesetofalarmsignalsthat:

a）ispriorityencodedandmeetstherequirementsofTable3and4aswellasfigure1;or

201.3.3.1

Identical

b）isgeneratedbymeansofdifferenttechnologyandisvalidated

201.3.3.1

Identical

Thealarmsystemisadditionallyprovidedwithother（additional）setsofauditoryalarmsignals,thefollowingapply:

201.3.3.1

Identical

c）auditoryalarmsignalsarepriorityencoded;

201.3.3.1

Identical

d）highpriorityauditoryalarmsignalsofaparticularsetofalarmsignalsconveyahigherlevelofurgencythanthemediumorlowpriorityalarmsignalsandinformationsignalsofthatalarmsignalset;

201.3.3.1

Identical

e）mediumpriorityauditoryalarmsignalsofaparticularsetofalarmsignalsconveyahigherlevelofurgencythanthelowpriorityalarmsignalsandinformationsignalsofthatalarmsignalset;

201.3.3.1

Identical

f）auditoryalarmsignalsvalidatedbyclinicalorsimulatedclinicalusabilitytesting

201.3.3.1

Identical

g）meansprovidedtostoreasetofauditoryalarmsignalsinthedefaultalarmpreset

201.3.3.1

Identical

h）meansprovidedtostoreasetofauditoryalarmsignalsinanyalarmpreset

201.3.3.1

Identical

AllmelodiesprecludethepossibilityofconfusionwiththeauditoryalarmsignalsofTable3,Table4andAnnexE

201.3.3.1

Identical

Meansareprovidedfortheusertopreventtheoperatorfromunauthorizedaccesstochangingtheauditoryalarmsignalsetinuse

201.3.3.1

Identical

6.3.3.2

Themeasuredauditoryalarmsignalsoundpressurerangeisdisclosedintheinstructionsforuse

201.3.3.2

Identical

Unlessadjustable,thesoundpressurelevelofmediumpriorityalarmsignalsdoesnotexceedthatofhighpriorityalarmsignals

201.3.3.2

Partial（1stEd.Doesnotmakeexceptionforadjustable）

Unlessadjustable,thesoundpressureleveloflowpriorityalarmsignalsdoesnotexceedthatofmediumpriorityalarmsignalsandtheyshallbedistinguishablefromalarmsignals.

201.3.3.2

Partial（1stEd.Doesnotmakeexceptionforadjustable）

Auditoryinformationsignalsareprovidedandtheyaredistinguishablefromthoseofauditoryalarmsignalsandtheircharacteristicsaredisclosedintheinstructionsforuse

201.3.3.2

Identical

6.3.4

RisksassociatedwithverbalalarmsignalsshallbeevaluatedaspartoftheRiskManagementprocess

201.3.4

New（1steditionhasnogeneralrequirement）

6.4.1

Ifthesumofthemaximumalarmconditiondelayplusthemaximumalarmsignalgenerationdelayisgreaterthan10s,andthestatisticsofeachdistributionorstatisticsofthedistributionofthesumaredisclosedintheinstructionsforuse

201.4.1

Identical

Ifthesumofthemeanalarmconditiondelayplusthemeanalarmsignalgenerationdelayisgreaterthan5 s,andeachdelayortheirsumisdisclosedintheinstructionsforuse

201.4.1

Identical

6.4.2

Thealarmsystemprovidedwithameanstosendorreceivealarmconditionsinadistributedalarmsystem,andtheinstructionforusedisclose:

a）thedelaytimefromtheonsetofthealarmconditiontothepointthattherepresentationofthealarmconditionleavesthesignaloutputpart;and

201.4.2

Identical

b）themaximumremotealarmsignalgenerationdelayorthetimetodeterminethegenerationofthetechnicalalarmcondition

201.4.2

Identical

ForaDISTRIBUTEDALARMSYSTEM,theALARMSIGNALGENERATIONDELAYmaybemeasuredand

reported,asapplicable:

201.4.2

Identical

c）fromtheonsetoftheALARMCONDITION

201.4.2

Identical

d）fromthetimeofthelocalALARMSIGNALgeneration;

201.4.2

Identical

e）toorfromthepointthatthepresentationoftheALARMCONDITIONleavestheSIGNALINPUT/OUTPUTPART;

201.4.2

Identical

f）toorfromthepointthatthepresentationoftheALARMCONDITIONarrivesattheSIGNAL

201.4.2

Identical

g）tothetimeoftheremoteALARMSIGNALgeneration.

201.4.2

Identical

6.5.1

alarmpresetsusemechanicaladjustmentsareexemptfromclause6.5

201.5.1

Identical

Alarmpresetsmeetingthefollowingareexemptfromtherequirementsofclause6.5:

a）canonlyretaincurrentALARMSETTINGS,and

b）doesnototherwiseprovideALARMPRESETS,and

c）displayseachadjustableALARMSETTINGScontinuously.

201.5.1

Identical

Theinstructionsforusecontaina