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1、MDRAnnexI附录一GeneralsafetyandperformancerequirementsChecklist通用安全和性能要求检查表Generalsafetyandperformancerequirements通用安全和性能要求Applicablity适用性StandardsUsed应用标准Evidencecomplianceorreasonfornoapplicability符合性证据或不适用理由Location-section位置-章节CHAPTERIGENERALREQUIREMENTS第1章一般要求1.Devicesshallachievetheperformanceint
2、endedbytheirmanufacturerandshallbedesignedandmanufacturedinsuchawaythat,duringnormalconditionsofuse,theyaresuitablefortheirintendedpurpose.Theyshallbesafeandeffectiveandshallnotcompromisetheclinicalconditionorthesafetyofpatients,orthesafetyandhealthofusersor,whereapplicable,otherpersons,providedthat
3、anyriskswhichmaybeassociatedwiththeiruseconstituteacceptableriskswhenweighedagainstthebenefitstothepatientandarecompatiblewithahigh.1.器械应具备制造商预期的性能，并确保其设计和结构在正常使用条件下适用于其预期用途。器械应安全有效，且不得对患者的临床症状或安全或者使用者或其他人员（如适用）的安全和健康造成损害，在最大限度保护健康和安全的同时，器械使用的可接受风险与其对患者的受益相比，应在可接受范围内，并应考虑到符合现有认知水平。2.Therequirementin
4、thisAnnextoreducerisksasfaraspossiblemeansthereductionofrisksasfaraspossiblewithoutadverselyaffectingthebenefit-riskratio.2.本附录中尽可能降低风险的要求，指尽可能降低风险的同时不会对受益-风险比产生不利影响。3.Manufacturersshallestablish,implement,documentandmaintainariskmanagementsystem.3.制造商应建立、实施、记录和维护风险管理体系。Riskmanagementshallbeundersto
5、odasacontinuousiterativeprocessthroughouttheentirelifecycleofadevice,requiringregularsystematicupdating.Incarryingoutriskmanagementmanufacturersshall:风险管理应理解为在器械整个生命周期中为连续迭代过程，需定期进行系统更新。进行风险管理制造商应做到：(a) establishanddocumentariskmanagementplanforeachdevice;制订并记录各器械的风险管理计划；(b) identifyandanalysethekno
6、wnandforeseeablehazardsassociatedwitheachdevice;识别和分析与各器械相关的已知和可预见的危害；(c) estimateandevaluatetherisksassociatedwith,andoccurringduring,theintendeduseandduringreasonablyforeseeablemisuse;估计和评价在预期使用时及在可合理预见的使用不当时产生的相关风险；(d) eliminateorcontroltherisksreferredtoinpoint(inaccordancewiththerequirementsofS
7、ection4;根据第4节的要求消除或控制(C)点所述的这些风险；(e) evaluatetheimpactofinformationfromtheproductionphaseand,inparticular,fromthepost-marketsurveillancesystem,onhazardsandthefrequencyofoccurrencethereof,onestimatesoftheirassociatedrisks,aswellasontheoverallrisk,benefit-riskratioandriskacceptability;and评估生产阶段，特别是上市后
8、监管体系的信息、危害及其发生频率、评估其相关风险及总体风险、风险利益比和风险可接受性。(f) basedontheevaluationoftheimpactoftheinformationreferredtoinpoint(e),ifnecessaryamendcontrolmeasuresinlinewiththerequirementsofSection根据(e)点所述信息影响的评估，必要时根据第4节的要求修改控制措施。4.Riskcontrolmeasuresadoptedbymanufacturersforthedesignandmanufactureofthedevicesshall
9、conformtosafetyprinciples,takingaccountofthegenerallyacknowledgedstateoftheart.Toreducerisks,Manufacturersshallmanageriskssothattheresidualriskassociatedwitheachhazardaswellastheoverallresidualriskisjudgedacceptable.Inselectingthemostappropriatesolutions,manufacturersshall,inthefollowingorderofprior
10、ity:4.制造商就器械的设计和生产所采取的风险控制措施应符合安全原则，并考虑到现有的技术水平。为降低风险，制造商应对风险进行管理，使各危害相关的剩余风险及总剩余风险控制在可接受范围内。在选择最合适的解决方案时，制造商应依据下述优先级原则：(a) eliminateorreducerisksasfaraspossiblethroughsafedesignandmanufacture;通过安全的设计和生产尽可能消除或降低风险；(b) whereappropriate,takeadequateprotectionmeasures,includingalarmsifnecessary,inrelat
11、iontorisksthatcannotbeeliminated;and如适合，采取适当保护措施，关于无法消除的风险，包含必要时的报警；且(c) provideinformationforsafety(warnings/precautions/contra-indications)and,whereappropriate,trainingtousers.提供安全信息(警戒/预防措施/禁忌)，并在适当情况下向使用者提供培训。Manufacturersshallinformusersofanyresidualrisks.制造商应将剩余风险告知使用者。5 .Ineliminatingorreduci
12、ngrisksrelatedtouseerror,themanufacturershall:6 .在消除或减少使用不当相关风险时，制造商应：（八）reduceasfaraspossibletherisksrelatedtotheergonomicfeaturesofthedeviceandtheenvironmentinwhichthedeviceisintendedtobeused（designforpatientsafety）,and尽量降低因器械人体工程学特点及其预期使用环境所造成的风险（针对患者安全而设计），以及（b）giveconsiderationtothetechnicalkno
13、wledge,experience,education,traininganduseenvironment,whereapplicable,andthemedicalandphysicalconditionsofintendedusers（designforlay,professional,disabledorotherusers）.针对技术知识、经验、教育、培训和使用环境，以及预期使用者医疗及身体条件（如适用）的注意事项（针对非专业、专业、残疾或其他使用者而设计）。6.Thecharacteristicsandperformanceofadeviceshallnotbeadverselyaf
14、fectedtosuchadegreethatthehealthorsafetyofthepatientortheuserand,whereapplicable,ofotherpersonsarecompromisedduringthelifetimeofthedevice,asindicatedbythemanufacturer,whenthedeviceissubjectedtothestresseswhichcanoccurduringnormalconditionsofuseandhasbeenproperlymaintainedinaccordancewiththemanufactu
15、rer5sinstructions.6.如器械在正常使用环境中使用并根据制造商的指示进行适当维护保养，在制造商声称的使用期限内器械的特性和性能不得对患者、使用者或其他人员（如适用）的健康或安全造成损害。7.Devicesshallbedesigned,manufacturedandpackagedinsuchawaythattheircharacteristicsandperformanceduringtheirintendedusearenotadverselyaffectedduringtransportandstorage,forexample,throughfluctuationsof
16、temperatureandhumidity,takingaccountoftheinstructionsandinformationprovidedbythemanufacturer.7.器械的设计、生产和包装应确保在根据制造商提供的说明和信息进行运输和储存期间（如温度和湿度的波动），不会对器械在预期使用期间的特性和性能造成不利影响。8.Allknownandforeseeablerisks,andanyundesirableside-effects,shallbeminimisedandbeacceptablewhenweighedagainsttheevaluatedbenefitstoth
