13544 report91123.docx
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13544report91123
JiangSuYuyueMedicalEquipment&SupplyCO.,LTD.
压缩空气式雾化器产品评估报告
EvaluationReportforAirCompressiveNebulizer
依据EN13544-1：
2007呼吸治疗设备-喷雾系统及其元器件
BasedStandardEN13544：
2007Nebulizingsystemsandtheircomponents
评估部门：
技术部门机构
Evaluatedby:
ResearchandDesignDepartment
地址………..
Location.....
评估项目江苏鱼跃医疗设备股份有限公司生产的医疗用压缩空气式雾化器产品
Itemdescription.....:
AirCompressiveNebulizermanufacturedbyJiangSuYuyueMedicalEquipment&SupplyCO.,LTD.
型号区分：
403A,403B,403C
Identification：
403A,403B,403C
评估依据：
欧盟标准:
EN13544-1:
2007----呼吸治疗设备---喷雾系统及其组件
EvaluationSpecification:
EN13544-1:
2007
评估结论：
上述型号的喷雾器产品符欧盟标准:
EN13544-1:
2007内容条款之要求
Evaluationresult:
ThenebulizersmentionedarecompliancewithEN13544-1:
2007
Evaluatedby:
reviewedby:
___________________________________
Evaluationreport
En13544-1:
2007
Part1:
Nebulizingsystemsandtheircomponents
喷雾系统及其组件
possiblecaseverdicts（可能情况之的评估判定）
theclausedoesnotapplytheevaluatingobject………..N（条款不适用评估产品）
theOBJECTdoescomplywiththerequirements……..P（评估产品符合要求）
theOBJECTdoesnotcomplywiththerequirements…F（评估产品不符合要求）
Generalremark:
（一般说明）
Models,403A,403Band403Caresimilarexceptasenclosure,PCBlayout,circuitinputrating,andpoweradapter.
Theirinterrelatedconstructiondatacomesfromtheoriginaltestreportsrespectively,whichhavebeentestedanddeterminedtobeinaccordancewiththerequirementsoftestspecificationEN60601-1:
1990,andareappliedtothisreport
上述产品的相关的结构数据来自原测试报告。
这些报告符合医疗标准EN60601-1:
1990,EN60601-1-2:
2001的要求，并被本报告所引用
En13544-1:
2007
Clause
条款
Requirements
要求
Result
结果
Verdict
评价
5
Classification
ClassIIB
P
6
Identification,markinganddocuments
6.1
Markingontheoutsideofequipmentorequipmentparts
P
e）Thenameortrademarkandaddressofthemanufacturer.FordevicesimportedintotheEuropeanUnionthefollowingapplies:
thenameoraddressofpersonresponsibleorauauthorizedrepresentativeofthemanufacturerortheimporterestablishedwithinEuropeanCommunityshallbeprovidewiththedeviceorwiththeaccompanyingdocuments
P
aa）allflow-directionsensitivecomponents,breathingattachmentsorparts（e.g.maskormouthpieceone-wayvalv）shallbeeitherclearlyanddurablymarkedwithanarrowshowingdirectionofgasflowifoperator–detachable,orshallbepermanentlyattached（seenotof6.8.2dd）
N
bb）ifgas-specific,theinletandoutletshallbeidentifiedbyclearanddurablemarking
N
cc）markingofdevices,labelsandpackaging
devices,labelsand/orpackagingshallcontainthefollowing:
---deviceidentificationandcontentinformation
P
---ifappropriate,thesymbolSTERILEinaccordancewithEN980togetherwiththemethodorsterilization
N
---ifappropriate,thebatchcode,precededbythesymbolLOTinaccordancewithEN980,orserialnumber
P
---theexpirydate,ifthedeviceissensitivetostorageorshelflifeinaccordancewithEN980
P
---ifappropriate,anindicationthatthedeviceisforsingleuse
P
----anyspecialstorageand/orhandingconditions
P
---Anywarningand/orprecautiontotakee.g.compatibilitywiththeuseofoxygenandoxygenmixtures,andcompatibilitybetweenoxygenandadministereddrug
N
---Foractivemedicaladvicestheyearofmanufactureexceptforthosecoveredby6.1cc）5thdash
Note:
thisindicationcanbethebatchorserialnumber
P
---Ifappropriate,therecommendedmethodofcleaning,disinfectionandsterilization
P
---devicepackagingand/orlabelingshalldifferentiatebetweennon-sterileplacedonthesameorsimilarproductsbothsterileandnon-sterileplacedonthemarketbythemanufacture
N
---ifappropriate,packagescontainingpartsmadeofconductivematerialshallbeclearlymarkedwiththeword“ANTISTATIC”or“CONDUCTIVE”
N
---theliquidcontainerofthenebulizershallbemarkedatthemaximumfillinglevel.Thisshallbedefinedintheinstructionforuse（see6.8.2aa）9thdash）
P
6.3
Markingofcontrolsandinstruments:
（控制器和仪器标志）
aa）gassupplypressuresshallbedisplayedinkPa
N
6.4
Symbols符号
P
6.8.2
Instructionofuse（使用说明）
aa）asfarasapplicablethefollowinginformationshallbeprovidewiththenebulizingsystem,itspartsorthepackage:
（尽可能地提供有关喷雾系统，其零件或包装的下列信息）
---thepurposeandintendeduseofthenebulizingsystemand/orparts喷雾系统及部件的用途及目的
P
---alistofnecessarypartswhicharenotanintegralpartofthenebulizingsystem
（喷雾系统之非整体部分的必需的零件清单）
P
---astatementthatthepartslistedin6.82aa）2nddasharerequiredforcorrectfunctionandthattheyhavetobeincompliancewiththisEuropeanStandard（声明上述零件符合本标准
P
---theminimumandmaximumrecommendeddriving–gasflowsandthecorrespondingpressuresforgas–powernebulizer
N
---R）-theparticlesizedistributioncurve,measured
asdescribedinAnnexCC,figureCC.3,ormeasuredwithanalternativetype-testmethodvalidatedasdescribedin4.3,underthenormaloperationconditionsformaximum,andminimum,ifapplicable,pressuresandflow
（须有）符合附录CC或类似测试的颗粒尺寸分布
P
----Theaerosoloutputandaerosoloutputrateminimummaximumandrecommendedmiddiving–gasflowsandfillvolumesalongwiththecorrespondingpressuresinthetestingconditionsdefinedinAnnexCC.
P
---Whetherthenebulizerissuitableforuseinanaestheticsystemsorlungventilatorbreathingsystem
N
---Themaximumtemperature,ifaboveambient,reachedinthenebulizingchamberforthemaximumrecommendedfillvolumeorthesolutioninnormaluseconditions
P
---themaximumandminimumrecommendedfillvolumeasdeclaredbythemanufacturer
P
---detailsofrecommendedpowerorcontroldevicesandaccessoriesforusewiththenebulizer
P
---themaximumA-weightedsoundpressurelevelasmeasuredinclause26
N
---astatementthatperformanceinformationprovidedbythemanufacturerinaccordancewiththisEuropeanstandardmaynotapplytodrugssuppliedinsuspensionorhighviscosityform.Insuchcases,informationshouldbesoughtfromthedrugsupplier
（需）一个陈述或声明：
符合本标准的性能也许不适用悬浮状或高浓粘度形式的药物。
此情况下，应向药商需求信息
P
---therecommendeddrivinggases
N
bb）asfarasapplicablethefollowinginformationshallbeprovidedwithpoweredand/orcontroldeviceitspartsorthepackagesthereof:
---therecommendedrangeofgasflowsandthe
correspondingpresses
N
---therecommendedgas（es）orgasmixture（s）
N
----detailsofrecommendedpowerorcontroldevicesandaccessoriesforusewiththepowerorcontroldevice;
P
cc）theinstructionforuseshallcontaininformationonmethodsofcleaningand/orsterilizationpriortouseandthenumberofcyclesofcleaningsand/orsterilizationsthenebulizingsystemwillwithstand.Theseinstructionshallcontainproceduresforreassembly（see6.82dd）
P
dd）dismantlingandreassembly
themanufacturershallrecommendafunctionaltestofoperationtobecarriedoutafterreassemblyandbeforeuse
N
ee）informationaboutmonitoring,alarmandprotectionmodules;asfarasapplicabletheinstructionsforuseshallcontain:
---Adescriptionofthemethodsofveryingalarmfunctions;
N
---Detailsofanypressurereliefvalvesfitted;
N
ff）informationaboutelectromagneticcompatibility
P
gg）informationaboutdisposal（有产品处理信息）
theinstructionforuseshallincludeinformationaboutanyprecautiontobetakenifitisaspecificunusualriskassociatedwiththedisposalofadevice若装置有特定不同的处置危害，说明书上应有处理措施警告信息
P
6.83
Technicaldescription
Technicaldescriptionshalladditionallyincludethefollowinginformation:
（附加技术规格描述信息如下）
---Interdependenceofcontrol,ifapplicable
---Thepressureandflowcharacteristicsofanygaspoweroutletunderworstcaseconditionsstatedbythemanufacture
N
---Thespecifiedrangeofflowsrequiredfromanygassource,ifapplicable;
N
---Ifrelevant,astatementofthecompositionanddrynessspecificationfororgasestobesuppliedtothenebulizer;
N
---Detailsofnon-returnvalvesandpressurereliefvalvesandtheircharacteristicsiffitted;
N
---Lifetimeofreusableparts
P
7
Powerinput（功率输入）
130VA
P
8
Basicsafetycategories（基本安全分类）
II类设备B型应用部分
P
10
Environmentalconditions（环境条件）
环境温度：
10℃~40℃
相对湿度：
30%~75%
大气压力：
70KPa~106KPa
10.101
IfitisdeclaredbythemanufacturerthatanebulizerisintendedtobedirectlyconnectedtopipelinesystemcomplyingwithENISO7396-1orapressureregulatorcomplyingENISO10524-1,thenebulizershllmeettherequirementsofthisEuropeanStandardforapneumaticpowerhavingarangeof280kPa（2,8bar）to600kPa（6bar）andshallnotcauseasafetyhazardundersinglefaultconditionsofthemedicalgassupplyi.e.upto1MPa（10bar）inletpressure.
Thetime-weightedaverageinputflowrequiredbythemedicalequipmentshallnotexceed60l/minatapressureof280kPa（2.8bar）atthegasinletport
N
14
Requirementsrelatedtoclassification
有关分类要求
P
15
Limitationofvoltageand/orenergy
电压和或能量限制
P
16
EnclosureAndProtectiveCovers
外壳和防护性盖
P
17
Separation隔离
P
18
Protectiveearthing,functionalearthingandpotentialequalization保护性接地，功能性接地以及电位补偿
N
19
Continuousleakagecurrentsandpatientauxiliarycurrents连续漏电流和病人辅电流
外壳漏电流：
正常0.1mA，单一故障状态0.5mA
患者漏电流：
正常0.1mA，单一故障状态0.5mA
P
19.1e
---Thepatientleakagecurrentshallbemeasuredwiththenebulizerfilledwithsalinesolutioncontaining9g/1sodiumchloridetothemaximumrecommendedvolume
---thenebulizeristestedwithametalfoilwrapp
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