ReviewReportNotestocriticalaspects/Comments評審的文件/關鍵部分備注/ Tableof*Techfilecoversoneproduct*productgroups**IndexwithresivionAttentionifitisafollow注意如果是跟蹤審核Especiallyintheinstructionforuse/advertisingmaterialtheintendedusemightbechangedwithconsequencestoclassification Referencetosimilarand*Devicedescriptionwithvariants( l.lifetimeoftheproduct),accessories,combinationwithother years年 Thedevice ludinoparts:ClipsisTitanium,cartridgeisnylon6.6.Theshelflifetime(sterilizationexp.date)is5year.Thelifetimeismorethan15year.Therealagingwasdone,theperformanceevaluationofproductandpackagewasdoneandfoundtobeacceptable.thesummaryreportno.PartBChapterXIX,2012.09.12.Thetestreportno.12-97for5shelflifetimeNote:Pleaseindicatewhichattributesofthedeviceludingvariantsand* ReviewReportNotestocriticalaspects/Comments評審的文件/關鍵部分備注/intendeduse!Anyparticularperformanceclaimsorproductbenefitsclaimedshouldbeverifiedbyadequateclinicaldataordesigntesting.Thisneedtobe*PartA,chapterI,productdescription:intendduseismarkingand/orligatingofanytissuestructuresorveaaelsduringanoperationforhaemostasisormarkingpurpose.In b thejustificationforthedeviceclassificationissufficientlyrobustinparticularinborderlinecaseandinthecaseofcombinationproducts.*Thesurgicalinvasivedevice,imntabledevice.PartAchapterI在邊緣情況和組合產品billofmaterial材料清單electricalcircuitsblockdiagrams電氣原理Producttechnicaldrawingno.Drawing#1to13formoldandcomponents.BOMlist,clipandcartridgeidefinedinthepartBchapterX. softhemanufacturer:PartBchapterNote:Pleaseinformationoncriticalaspects(ifapplicable);e.g.dimensionsofcritical electricalcircuitdrawings(blockdiagrams)shallbepartoftheTD. ReviewReportNotestocriticalaspects/Comments評審的文件/關鍵部分備注/*ENENISOENLabelingrequirementsfromproductspecificThepackageSpecification,labelsdrawingno.KMD03-01-01,boxdrawingno.KMD-03-02-01,externalBoxdrawingno.KMD03-03-01.Andbackageboxspecificationno.PartAchapterV. softhemanufacturer:制造PartAchapterRelatedwarnings*otherhazardousmaterial其它有害物質:containslatex(e.g.EN455-3,ENISO* aseofre-usingsingle-useIFUspecificationno.IFU-TCJJ-ENG-01Rev.3/12.09.2012.theproductspec.instructionforuse,warningandprecautionsmeasures,manufacturer,andEU–rep.CEmarkhasbeenclearlydefined. softhePartAchapter(followup:tracepotentialmaterialBlisterpackage,PVCcoiledmaterialand ReviewReportNotestocriticalaspects/Comments評審的文件/關鍵部分備注/PackagingvalidationENISO11607-ENISO11607-ThevalidationreprotofblistersterilepackingSealingprocessno.QDKM-01/13.BlisterFormingtemperature:85-100OC,Sealingtemperature:110-115OC,theconveyorspeedispredeterminedbythemachine#ZD-030.Thestablabilityandperformancewasd reportno.IN-11/8.2.4.ReferencesofthePartAchapterTheevlautionreportno.QDKM-01/11,lungthedro ,sharkingtrailofthebox. softhePartAchapterNote:Pleaseprovidegeneralinformationtoallowareviewertoobtainamanufacturingprocesses. l.usedandindicationofspecialThemainprocessforLigationClipsclipformingludingtheV-shapedclipsandChevronShapedclips,thefollowingprocessesspecification(WIno.0301)andflowchart(WITF-CL1,partB,ChapterXIV).Thecartridgeproduction,twopartWI-1BA,WI-1CA,theUltrasonicwash(Clips/cartridge)→thedrying→theassembly→theheatsealing→ETOsterilization(outsideofcleanrooms etheprocess)→packing arton→FQC softhePartBchapterInformationisinaccordancewithinformationonTUVRheinlandproductlist(whichispartoftheproject ReviewReportNotestocriticalaspects/Comments評審的文件/關鍵部分備注/(ER)checklistNote:Whenanapplicableharmonizedstandardwasnotappliedoronlypartiallyappliedbythemanufacturerbeprovidedhere!Note:Non-applicablerequirementsneedtobenotedandjustifiedassuchinthemanufacturer’sPleaseprovideevidencehowthevalidityofthefulfilltheERwaschecked.e.g.Properreferencestotestreportswereprovidedinthechecklist?IsthereferencetoothersectionsoftheTechnicalationproperlyedanddothesesectionsgiveevidencethatrelevantaspectsoftheERwerefulfilled?*fulfilled:usingharmonizedstandardsfulfilled:withotherstandardsfulfilled:forproductMorespecificEssentialHealthandSafetyRequirementssetoutinAnnexIofDirective2006/42/ECwereaddressedfordeviceswhicharealsomachineryasofa.m.TheER–checklistno.PartB,ChapterXIrev.03,date2010.03.18.applicableharmonaizedstandardandrelevantevlautionandtestevidencewasmentonedinthelist.Thematerialfunction,performance,packaging&labeling,sterilzation,biocompatibiltiywasinvlovedandfoundtobeacceptbale. softhePartBchapterListofapplied/harmonizedNote:Thelistofthemanufacturermayalsobe*Theappliablestandardlistno.partA,.harmonizedstandardwasadqua identified.nochanges elastaudit.Referencesofthemanufacturer:PartAchapter ReviewReportNotestocriticalaspects/Comments評審的文件/關鍵部分備注/Risk ysis(=RA)andcontrolsummaryNote:Pleasesummarizethatallmainhazardsassociatedwiththedeviceinquestionwereevaluatedbythemanufacturer(someproductspecificexamplesshallbegiven).IsevidenceprovidedthattheresultisbasedonariskmanagementprocessaccordingENISO14971(l.post-productionphaseIsevidenceprovidedthatawithMDD,AnnexI.2isMDD,Annex1.2？*TheriskmanagementofdevicewasimplementedENISO14971:2012, parts,previousriskanlysisreportandpost–maketingsurveillanceevaluationreport.finalevaluaitonreportwasedin2013.09.10andfoundnonewriskandaprovalwasconfirmed. softheRiskManagementregister,FY2010,F-7.7.3,andFY2013F-7/7.3.ReviewReportNotestocriticalaspects/Comments評審的文件/關鍵部分備注/Notefortheassessmentofpre-clinicaldatabelow:Pleasesummarizeespeciallytheconclusiondrawnbythelegalmanufacturer(inthetechnicalation)regardingtotheaspectsbelow.Additionally,thetesting(which ReviewReportNotestocriticalaspects/Comments評審的文件/關鍵部分備注/ aseof“negative”testresultsthejustificationpropertiesofthedevicemustbeprovidedandjustifiedbytheEspeciallyiftheapproachofAnnexBandCofENISO10993-1:2010wasappliedtheappropriatenessoftheapproachshallbesummarizedbythereviewer.特別是通過適用ENISO*AlltestswereperformedasdefinedfortheproductcategoryintableA.1ofENISONotalltestswereperformedasdefinedfortheproductcategoryintableA.1ofENISO10993-1butaspectsnotcoveredbytestsaccordingtoENISO10993ff.wereevaluatedbasedontheapproachdefinedinENISO10993-1,AnnexBandC.品類別所規定的檢測都進行了。但不按ENISO10993系列標準進行測試的部分，已經ENISO10993-1:2010AnnexBCNotestswereperformedasdefinedfortheproductcategoryintableA.1ofENISO10993butaspectsnotcoveredbytestsaccordingtoENISO10993ff.wereevaluatedbasedontheapproachdefinedinENISO10993-1,AnnexBandC.10993-1:2010AnnexBC規定的方法ByanaccreditedlaboratoryhouseTheevlautionofbiocompatibilitybythematreialandcleanprocesseswasadquadelydone.prevoiusmaterialandprocesswasnotchange. softhemanufacturer: ReviewReportNotestocriticalaspects/Comments評審的文件/關鍵部分備注/Biologicalsafetyberelevantfornon-classIdevicesifnaturalsourcesl.animalsourcesareusedandforallmedicalofanimaloriginwithintact注：生物安全也可能和非I*ENISO22441-ENISO22441-ENISO22441- softhePhysicalNote:Physicalsafetyludesmechanicalcharacteristicsandsafetyrelatedtoionizingandnon-ionizingradiation.*Testreportno.VAL/06/13SS/6.WIno.IN-6/7.5.2;IN-11/8.2.4. softheThereport.Electrical* softhe*EN softhe*EN62366(=IECThecl ialevlautionreport uasbilityevlautionreport. softheReportno. ReviewReportNotestocriticalaspects/Comments評審的文件/關鍵部分備注/Clinical(MDD,AnnexNote:Summarizeyoursafetyandperformance*ENISO14155-ENISO14155- softheCrlevnofscentii eraure* ialevlautionreportno.CER01/11.Referencesofthemanufacturer:PartBChapterUpdatebypostmarketsurveillanceactivities*Every每1years年Post-maketingsurveillancereportFY2012. softhemanufacturer:PartBchapterNote:sampleno.forSamplepreparationprocedurecorrectionENISO11737-ENISO11737-Themicrobiologicalexaminaionreportno.13-4.Threelots.Model0301-06S. softheThereportFollowup:lookatmaintenancedocsformajorchangesinequipmentpriortorevalidationdocs.AsepticENISO13408- softhe ReviewReportNotestocriticalaspects/Comments評審的文件/關鍵部分備注/ENISO11135-ENISO11137-ENISO ReviewReportNotestocriticalaspects/Comments評審的文件/關鍵部分備注/Note:Pleasedescribekeycharacteristicsoftheprocessanditsvalidation.DuringtheTechnicalationreviewthefocusisontheperformancequalification(PQ):mostcurrentre-validationneedtobeprovided.Approachofvalidation(e.g.aworstcasescenario,useofaPCD[yesorno],validationwithaloadwhichwillbealsousedinroutinesterilizationcycles).Ifworstcasescenarioloadisused:whatwerethewhichleadtothedefinition.Therearetwosterlizationchamber,eqiupment#ZD-006,volume6M3,newchamber#ZD-030,20M3,duringtheaudit,the20M3equi ntvalidationreportwasreviewed.Thereportno.05/12BS.luidngfoursteps:prconditioning,conditioningexposure,earation.ThevalidationprocessofZD-030,20M3wasasfollowing:IntheMPQstep,reportno.PQM-R-05/12.thebioburdentestwasdone,theaverageresultofthreelotsdevicegenerallyavailablethereportno.PQM-LT-05/12BS-BT.TheFractionnegative(HSKP)istaken;sevencycleswithBIswereperformedinthevalidationprocess.Finalprocessesspecificationwasdeterminatesasfollowing:warmingproductsup:-initialnegativepressure:-minimumtime:11minimumT1temperatureat:watertemperaturesetT13-relativehumidity minimumtemperatureT1atstart:relativehumidity:-watertemperaturesetT13pressure:-timetoachieve:45-60minimumtimetokeep:5EOgasconcentrationspan:560-time(countedaftercompletionofEOinjection)-pressure:--timetoachieve:-ty:-Intheaerationroom:2daysto11daysroutineconditiondependonthedifferentproducts,definedinthereportno.DQ-R-05/12BSinmoredetailed. softhemanufacturer(alsodatesofinitialandmostcurrentre-validationInitialreport,07/1.Mostcurrentvalidation05/12BS, ReviewReportNotestocriticalaspects/Comments評審的文件/關鍵部分備注/InformationisinaccordancewithinformationonTUVRheinlandproductlist(whichispartoftheproject DeclarationofNote:Referencetobatchno.provided(e.g.asreferencetoabatchrelatedapproval)*issuedbefore21stMarch2010andgivesreferenceto2007/47/ECissuedafter21stMarch2010201