(医疗(含居家)标准介绍)-2014.pptx

IEC/EN 60601-1課程介紹 2014-07-25 Frank 課程大綱課程大綱1EN60601-1:2006+A11:2011+A1:2013 Develop2EN60601 part 1 介紹介紹3新舊版本差異新舊版本差異4常用標準設計差異常用標準設計差異5EN60601 part 11 說說明明6Q&AEN60601-1:2006+A11:2011+A1:2013時程時程EN標準公告日期 -EN60601-1:2006DOP:2008/11/27;DOW:2012/6/1 -EN60601-1:2006/A11:2011DOP:2012/10/1;DOW:2014/10/1 -EN60601-1:2006/A1:2013DOP:2014/6/24;DOW:2018/12/24 Date of publication(dop)latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement Date of withdrawal(dow)latest date by which national standards conflicting with an EN(and HD for CENELEC)have to be withdrawn IEC/ANSI/AAMI ES/EN/CSA60601-1標準版本標準版本Deviation version3.0版版3.1版版IEC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+A1:2013Standard Update NewsEN60601 part 1介紹介紹2011-03-14:Risk management for power supplies and other 60601 components AcomponentpowersupplycanbeissueditsownCBTestCertificatetoIEC60601-1:2005,3rdEdition.WherethesupplierdoesnotperformariskmanagementprocessasrequiredbyIEC60601-1:2005,3rdEdition.IfapowersupplyissubmittedforCBTestCertificateagainstIEC60601-1,2005asastand-aloneproductitwillbeevaluatedagainstallclauses/requirementsofthestandardthatareapplicableforthatdevice.ThiswillincludethefullriskmanagementprocessusingtheentirestandardIEC60601-1:2005,3rdEdition,asapplicable.*Medical PCB type:no need for “risk management”document;Medical adaptor:not a complete medical device,no need for “risk management”document.Risk management for power suppliesMOPP:MeansOfPatient Protection(need2*Y-capforthisusage)Terminology and DefinitionsMOOP:MeansOfOperator Protection(1*Y-capisOKforthisusage)*MW will complete the update of all medical PCB series with 2*Y-cap by 2012 in order to cover the most applications!Terminology and DefinitionsAccordingtothelatestIEC60601-1:2005,oneY1capacitorisconsideredasoneMOPP(MeansOfPatient Protection)or2MOOP(Means OfOperatorProtection).OurProductwillconsidereddefinitiontoMOPP.Tomeettheaboverequirement,weareworkingonre-layouttohave2Y1Capacitorsbridgingdoubleinsulationbetweenprimaryandsecondarynow.明緯產品定義:MOOP:MSPseries(100/200/300)=HRPG轉換 MOPP:OthersTerminology and DefinitionsMOOP VS MOPPMOOP(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.B1500Vac,D/R:3000Vac.Table6&Table7.B:1500Vac,D/R:4000Vac.Bridgedcap.TwoMOOP:(1)Y1cap,*1or(2)Y2cap.*2.TwoMOPP:Y1cap.*2.MOOP VS MOPPMOOP(MeansOfOperatorProtection)MOPP(MeansOfPatientProtection)CREEPAGEDISTANCE(mm)AIRCLEARANCE(mm)CREEPAGEDISTANCE(mm)AIRCLEARANCE(mm)(1).L-Nbeforefuse.(2).Betweenfuse.3.0Table11)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)Class of Applied PartsClass of Applied PartsEN60601-13rd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:60601-1 part 1常見設計問題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class)1.-20%=80Vac2.+10%=264Vac滿載EN60601-13rd溫度測試要求60601-1 part 1常見設計問題常見設計問題EN60601-13rd破壞測試要求要求:破壞測試不接受變壓器斷裂 60601-1 part 1常見設計問題常見設計問題Triple Wire 選用選用醫療產品三層絕緣線僅限用TotokuTIW-2,TIW-3TIW-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。60601-1 part 1常見設計問題常見設計問題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前前 X Cap.和洩放電阻和洩放電阻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.20131/11/12 David裁示:後續機型不得將此兩元件置於Fuse前60601-1 part 1常見設計問題常見設計問題Fuse與與Fuse前其他零件的選用前其他零件的選用 Fuse 1.Class:L,N 皆需提供 Fuse.2.Class: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60601-1 part 1常見設計問題常見設計問題Discharge ICDischarge ICIECEE於2013/5發佈放電IC須符合CTLDecisionsheet(No1080)所指定的相關測試,-HumidityTest-ImpulsesTest-110%ACratedvoltagefor2.5minutes-10,000cyclespoweron/offtestn n 廠內做法廠內做法廠內做法廠內做法=直接採用直接採用直接採用直接採用IEC/EN/UL 60950-1 IEC/EN/UL 60950-1 認可的放電認可的放電認可的放電認可的放電IC,IC,留意留意留意留意PSUPSU線路設計需與線路設計需與線路設計需與線路設計需與IC IC 認證時搭配的認證時搭配的認證時搭配的認證時搭配的外兜線路外兜線路外兜線路外兜線路&報備規格報備規格報備規格報備規格相符相符相符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Input current rating 需比照進行60601-1 part 1 其它問題其它問題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Suitable for BF application with appropriate system consideration.1明緯後續開發之medicalpower，須符合I/PO/P：2MoPPO/PFG：1MoPP並於規格書中的Features中說明Suitable for BF application with appropriate system consideration.2已上市機型，如符合1、1條件，可於規格書中的Features說明Suitable for BF application with appropriate system consideration.明緯後續開發之明緯後續開發之medical power設計重點設計重點新舊版本差異新舊版本差異 EN60601-1:2006+A11:2011+A1差異差異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).(cl8.9.1.18.9.1.6).(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:(cl72.4)a.Contactinformation.b.Seriesnumber.c.Dateofmanufacture.EN60601-1:2006+A11:2011+A1差異差異常見標準設計差異常見標準設計差異 Construction X cap discharge 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DampheattestElectric strength test Leakage Current Test(Touch Current)Limit Current Circuit Test(LCC)建議容值:居家照護醫療器械規範EN60601-1-11介紹介紹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:IEC60601-1-11:2010 ScopeEN60601-1-11針對操作者的定義:IEC60601-1-11:2010 ScopeEN60601-1-11:Class僅接受永久連接性設備IEC60601-1-11:2010 Scopea).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7.214.8Vdc測試.g).廠商自行宣告環境不同於”+540,15%93%R.H.7001060hPa時,則需增加評 估thermalshocktest.EN60601-1-11SmallfingerprobeIEC60601-1-11 設計重點設計重點Leakagecurrents,HeatingperformanceduringnormalandsinglefaultconditionsIEC60601-1-11 設計重點設計重點ME EQUIPMEN T typeProfessional healthcare facilityHOME HEALTHCARE ENVITONMENTNon-LIFE-SUPPORTING+10%/-10%+10%/-15%LIFE-SUPPORTING+10%/-10%+10%/-20%TheMEREQUIREMENTshallcomplywiththestandardandshallremainoperationalinNORMALUSEwithinitsspecificationsunderthefollowingoperatingconditionsIEC60601-1-11 設計重點設計重點ME EQUIPMEN T typeProfessional healthcare facilityHOME HEALTHCARE ENVITONMENTAlltypesexceptSTATIONARYDefinedbyMANFACTURER-25atanyR.H.+70/R.H.93%ME EQUIPMEN T typeProfessional healthcare facilityHOME HEALTHCARE ENVITONMENTAlltypesDefinedbyMANFACTURER+5+40/-15%93%R.H,700hPato1060hPaMechanical Strength(non-Transit-operable)集團常申請法規集團常申請法規集團常申請法規集團常申請法規&標準有效期標準有效期標準有效期標準有效期Product CategoriesEN Standard&Date expiredIEC Standard&Date expiredULInformation Technology Equipment(Ex:RS-25,SP-100/150/200)EN60950-1:2006+A12:2011EN60950-1:2006+A2:2013(DOW)2016-07-02IEC60950-1:2005+A2UL60950-1,2nd Edition 2011-12-19Medical Equipment(EX:GSM-40,60A/B,MSP-600)EN60601-1:2006+A11:2011EN60601-1:2006+A1:2013(DOW)2018-12-24EN60601-1-11:2010IEC60601-1:2005+A1EN60601-1-11:2010ANSI/AAMI ES60601-1:2005+A1:2012ANSI/AAMI HA60601-1-11:2011Household ApplianceEx:PA/PB/PS-120,PB-600)EN60335-1:2012EN60335-2-29:2004+A2IEC60335-1:2010IEC60335-2-29:2002+A2XLED controlgear/Class 2 Power Units(Ex:HLG-80,LPF-40,PCD-25,HVGC-100)EN61347-1:2008+A1:2011EN61347-1:2008+A2:2013(DOW)2016-01-01EN61347-2-13:2006IEC61347-1,ed2:2008+A2 or A1IEC61347-2-13,ed1UL8750,1ST EditionIndustrial Control Equipment(EX:DR-45/100/120;WDR-120/240/480)XXUL508Inverter power supply(EX:TN/TS/ISI-3000)XXUL458Switch model power supply and transformers(EX:RSP-75/100/150)EN61558-1:2005+A1EN61558-2-16:2009IEC61558-1IEC61558-2-16XQ&A