(医疗(含居家)标准介绍)-2014

IEC/EN60601-1課程介紹

2014-07-25

Frank

課程大綱1EN60601-1:2006+A11:2011+A1:2013

Develop2EN60601

part

1介紹3新舊版本差異4常用標準設計差異5EN60601

part

11說明6Q

&

AEN60601-1:2006+A11:2011+A1:2013時程EN標準公告日期

-EN60601-1:2006

DOP:2008/11/27;DOW:2012/6/1

-EN60601-1:2006/A11:2011

DOP:2012/10/1;DOW:2014/10/1

-EN60601-1:2006/A1:2013

DOP:2014/6/24;DOW:2018/12/24

Dateofpublication(dop)latestdatebywhichanENhastobeimplemented

atnationallevelbypublicationofanidenticalnationalstandardorby

endorsement

Dateofwithdrawal(dow)latestdatebywhichnationalstandardsconflicting

withanEN(andHDforCENELEC)havetobewithdrawnIEC/ANSI/AAMIES/EN/CSA60601-1標準版本Deviationversion3.0版3.1版IEC俗稱：IEC60601-1(3.0版)又稱：IEC60601-1:2005;詳細：IEC60601-1:2005;CORR1:2006;CORR2:2007俗稱：Amendment1(3.1版)又稱：IEC60601-1:2005+A1:2012詳細：IEC60601-1:2005;CORR1:2006;CORR2:2007;AMD1:2012US俗稱：UL

(3.0版)又稱：AAMIES60601-1;詳細：AAMIES60601-1;CORR1:2009;AMD2:2010;俗稱：ULAmendment1

(3.1版)又稱：AAMIES60601-1&A1:2012;詳細：ANSI/AAMIES60601-1:2005/(R)2012andA1:2012,C1:2009/(R)2012andA2:2010/(R)2012CANCAN/CSA-C22.2No.60601-1:08CAN/CSA-C22.2No.60601-1:2014ENEN60601-1:2006/A11:2011EN60601-1:2006/A11:2011+A1:2013StandardUpdateNewsEN60601

part1介紹2011-03-14:Riskmanagementforpowersuppliesandother60601componentsAcomponentpowersupplycanbeissueditsownCBTestCertificatetoIEC60601-1:2005,3rdEdition.WherethesupplierdoesnotperformariskmanagementprocessasrequiredbyIEC60601-1:2005,3rdEdition.

IfapowersupplyissubmittedforCBTestCertificateagainstIEC60601-1,2005asastand-aloneproductitwillbeevaluatedagainstallclauses/requirementsofthestandardthatareapplicableforthatdevice.ThiswillincludethefullriskmanagementprocessusingtheentirestandardIEC60601-1:2005,3rdEdition,asapplicable.**MedicalPCB

type:

no

need

for

“risk

management”

document;Medicaladaptor:notacompletemedicaldevice,no

need

for

“risk

management”

document.RiskmanagementforpowersuppliesMOPP:MeansOfPatientProtection(need2*Y-capforthisusage)TerminologyandDefinitionsMOOP:MeansOfOperatorProtection(1*Y-capisOKforthisusage)**MWwillcompletetheupdateofallmedicalPCBserieswith2*Y-capby2012inordertocoverthemostapplications!TerminologyandDefinitionsAccordingtothelatestIEC60601-1:2005,oneY1capacitorisconsideredasoneMOPP(MeansOfPatientProtection)or2MOOP(MeansOfOperatorProtection).OurProductwillconsidereddefinitiontoMOPP.Tomeettheaboverequirement,weareworkingonre-layouttohave2Y1Capacitorsbridgingdoubleinsulationbetweenprimaryandsecondarynow.明緯產品定義:

MOOP

:

MSPseries(100/200/300)<=HRPG轉換

MOPP

:OthersTerminologyandDefinitionsMOOPVSMOPPMOOP(MeansOfOperatorProtection)MOPP(MeansOfPatientProtection)TheminimumvaluesforClearanceandCreepagedistancerequirementAreharmonizedwithIEC60950-1:2001AreharmonizedwithIEC60606-1:1998+A1:1991+A2:2005VoltagelimitsonaccessiblepartsoutsidethepatientEnvironment42.4Vpeakor60VdcAccessiblevoltageonpartsonesecondaryafterdisconnectionsfromtheMainssupply60Vor45uCAltitudesupto2000mThevaluesforairclearancearedefinedforaltitudesupto2000meters.Forhigheraltitudescorrectionfactorsiapplied(derivedfromIEC60664-1:1992asamended)forbothMOOPandMOPP.DielectricstrengthtestFollowsvaluesidenticalthesegivenIEC60950-1:2001.Newvaluesaredefined(higherthantheseforMOOP,differentfromIEC60601-1:1998+A1+A2standard)Table6&Table7.<354Vpk=>B:1500Vac,D/R:3000Vac.Table6&Table7.<354Vpk=>B:1500Vac,D/R:4000Vac.Bridgedcap.TwoMOOP:Y1cap,*1orY2cap.*2.TwoMOPP:Y1cap.*2.MOOPVSMOPPMOOP(MeansOfOperatorProtection)MOPP(MeansOfPatientProtection)CREEPAGEDISTANCE(mm)AIRCLEARANCE(mm)CREEPAGEDISTANCE(mm)AIRCLEARANCE(mm)(1).L-Nbeforefuse.(2).Betweenfuse.3.0(Table11)1.6(Table11)2.0(A1加嚴)3.0(Table11)1.6(Table11)2.0(A1加嚴)ForinsulationintheMAINSPARTbetweenpartsofoppositepolarity,theminimumCREEPAGEDISTANCESandAIRCLEARANCESarenotrequiredifshortcircuitingofeachsingleoneoftheseCREEPAGEDISTANCESandAIRCLEARANCESinturndoesnotresultinaHAZARDOUSSITUATIONBasicinsulation:Primary-Ground2.5(Table16)2.0(Table13+Table14)4.0(Table12)2.5(Table12)Doubleinsulation:Primary-Secondary5.0(Table16)4.0(Table13+Table14)8.0(Table12)5.0(Table12)ClassofAppliedPartsClassofAppliedPartsEN60601-13rd溫度測試要求■要求:

外置型產品的溫度測試需於testcorner下執行測試■原因:產品可能會放置在牆角或櫥窗內,故安規要求執行溫度測試需考量最差條件.

(例外:Openframetype不須遵循此要求)

(注意:GSM全系列都須符合上述要求)■Testcorner說明:(nextpage)

a.Testcorner:由兩個20mm厚的黑色面板組成.

b.產品的前方及側方需面向testcorner,且產品-testcorenr距離為其長/寬的1.5times.■TestVoltage說明:

60601-1part1常見設計問題類型機型範例測試輸入電壓測試輸出電壓OpenFramepower(申請EN60601-1)MSPseries1.-10%=>90Vac2.+10%=>264Vac滿載Adaptor(有申請居家醫療)(EN60601-1&EN60601-11)GSMSeries(僅限classⅡ)1.

-20%=>80Vac2.+10%=>264Vac滿載EN60601-13rd溫度測試要求

60601-1part1常見設計問題EN60601-13rd破壞測試要求要求:

破壞測試不接受變壓器斷裂

60601-1part1常見設計問題TripleWire選用醫療產品三層絕緣線僅限用TotokuTIW-2,TIW-3■TIW-2,TIW-3目前僅有MOPP證書,不符合MOPP,但現狀TUV可接受此證書.

=>

Totoku預計9月完成測試。

60601-1part1常見設計問題■TEX-E無法使用於工作電壓>250Vrms的產品.Totoku預計9月完成測試。

=>

Furukawa因市場需求過小，無計畫進行認證。Fuse前X

Cap.和洩放電阻■UL決議:不接受單顆電阻放置於fuse前.■原因:

a.醫療產品不接受前breaker保護.

b.醫療設備無法確認fuse前電阻的可靠度.

20131/11/12David裁示:後續機型不得將此兩元件置於Fuse前60601-1part1常見設計問題Fuse與Fuse前其他零件的選用■Fuse1.ClassⅠ:L,

N皆需提供Fuse.2.ClassⅡ:若不是永久連接式ME電源設備,

則N可以不加保險絲■Fuse前其他零件:

Varistor/Thermistor需使用安規認可零件,且至少需在N端Fuse後

Comment:建議設計前請先將所有零件考慮在fuse後60601-1part1常見設計問題DischargeIC

DischargeICIECEE於2013/5發佈放電IC須符合CTLDecisionsheet(No1080)所指定的相關測試,HumidityTestImpulsesTest110%ACratedvoltagefor2.5minutes10,000cyclespoweron/offtest廠內做法=>直接採用IEC/EN/UL60950-1認可的放電IC,

留意PSU線路設計需與IC認證時搭配的外兜線路&報備規格相符

電容放電測試須於1秒內降至60V,比60950嚴格.MOPP跨接電容須使用2顆Y1,Y電容需改用Y1type.Hi-pottest比二版嚴格,可能會導致舊機型耐壓不足問題.漏電流須考慮singlefaultcondition,故跨接電容建議不得大於1000pF(可使用兩顆2200pF),前方L-Earth&N-EarthY電容建議總容值不得超過4000pF,但仍需以實際測試為主.輸出對的可視終端應用來決定是否需要保持基本絕緣.若輸入電壓使用range或rating,則Inputcurrentrating需比照進行60601-1part1其它問題MWUSA於Jul-10新委會提出：medicalpower，(如電氣規格可行)建議於規格書的Features中明列SuitableforBFapplicationwithappropriatesystemconsideration.[1]明緯後續開發之medicalpower，須符合

<1>I/P–O/P：2MoPP

<2>O/P–FG：1MoPP

並於規格書中的Features中說明SuitableforBFapplicationwithappropriatesystemconsideration.[2]已上市機型，如符合[1]<1>、[1]<2>條件，可於規格書中的Features說明SuitableforBFapplicationwithappropriatesystemconsideration.明緯後續開發之medicalpower設計重點新舊版本差異EN60601-1:2006+A11:2011+A1差異MW

SPU主要影響1.Humiditytest須執行168hrifIPcodeisdifferentasIPX0.(cl5.7).2.Fuse前距離要求改為1*MOOP(2.5mm/2.0mm).(cl~).(並請留意海拔3000m問題).

=>原先要求為cr/cl:3.0/1.6mm=>A1版本改為cr/cl:2.5/2.0mm;且海拔超過2000m,須額外考量空間距離須再*一個係數.

=>因考慮版本將同時申請,故往後機型請以3.0/2.0mm設計for2000m.貼紙須控增加標示如下,且序號貼紙需執行測試並控管廠商型號,請務必選用UL認可用料.

NewMarkingrequired:(cl7.2.4)

a.Contactinformation.

b.Seriesnumber.

c.Dateofmanufacture.EN60601-1:2006+A11:2011+A1差異常見標準設計差異Construction

Xcapdischarge

新機型設計:請勿將X電容&洩放電阻設計於fuse之前,fuse前電阻會被要求控管廠商型號及60065認可品,部分標準會要求singlefault後距離要有BI;若為非認可品需增加評估DampheattestElectricstrengthtest

LeakageCurrentTest(TouchCurrent)

LimitCurrentCircuitTest(LCC)

建議容值:居家照護醫療器械規範EN60601-1-11介紹IEC/EN60601-1“+”居家醫療包含哪些設備居家醫療包含哪些設備居家醫療器材的定義a).appliestotheBASICSDFETYandESSENTIALPERFORMANCEofMEEQUIPMENTandMESYSTEM,whichareintendedbytheirMANUFACYIRERforuseintheHOMEHEALTHCAREENVIRONMENT,regardlessofwhethertheMEEQUIPMENTorMESYSTEMisintendedforusebyaLAYOPERATORorbytrainedhealthcarepersonnel.b).不適用專業或是緊急使用.c).下列場所不適用:

IEC60601-1-11:2010ScopeEN60601-1-11針對操作者的定義:

IEC60601-1-11:2010ScopeEN60601-1-11:ClassⅠ僅接受永久連接性設備

IEC60601-1-11:2010Scopea).至少需有IP22等級orIP02加上carrycase,並在外殼上加上ISO7000-0626marking.

IEC60601-1-11設計重點b).須防止測試手指碰觸到危險區域.(不同於EN60950-1)c).EMC需要考慮IEC60601-11.d).維生系統需具備不斷電系統設備.e).Normaltest需能符合電壓+10%及-20%or-15%.f).針對DC12V產品(電池搭配),建議須考慮7.2~14.8Vdc測試.g).廠商自行宣告環境不同於”+5~40℃,15%~93%R.H.700~1060hPa時,則需增加評

估thermalshocktest.

EN60601-1-11Smallfingerprobe

IEC60601-1-11設計重點Leakagecurrents,Heatingperformanceduringnormalandsinglefaultconditions

IEC60601-1-11設計重點MEEQUIPMENTtypeProfessionalhealthcarefacilityHOMEHEALTHCAREENVITONMENTNon-LIFE-SUPPORTING+10%/-10%+10%/-15%LIFE-SUPPORTING+10%/-10%+10%/-20%TheMEREQUIREMENTshallcomplywiththestandardandshallremainoperationalinNORMALUSEwithinitsspecificationsunderthefollowingoperatingconditions

IEC60601-1-11設計重點MEEQUIPMENTtypeProfessionalhealthcarefacilityHOMEHEALTHCAREENVITONMENTAlltypesexceptSTATIONARYDefinedbyMANFACTURER-25℃atanyR.H.~+70℃/R.H.<93%MEEQUIPMENTtypeProfessionalhealthcarefacilityHOMEHEALTHCAREENVITONMENTAlltypesDefinedbyMANFACTURER+5℃~+40℃/-15%~93%R.H,700hPato1060hPa

MechanicalStrength(non-Transit-operable)集團常申請法規&標