Sheet1of19WrittenBy:作者REV.ReviewedBy:审核ECNHistoryECN历史记录Date日期APPROVALS批准NAME名称FUNCTION功能APPROVAL批准SIGNATURE签名DATE日期DirectorofEngineering工程主管OperationsManager业务经理ProjectEngineer项目工程师PRODUCTS:产品：ProductName产品名称ModelNo.型号EngineeringNo.工程设计编号Sheet2of19TableofContents目录TABLE-E.1ENERGYHAZARDS表格E-1兼容危害性5ELECTROMAGNETICENERGY电磁兼容性5RADIATIONENERGY辐射电磁波5MECHANICALENERGY机械兼容性6TABLE-E.1BIOLOGICALANDCHEMICALHAZARDS表格E-1生化危害性7BIOLOGICAL生物学制品7CHEMICAL化学制品7BIOCOMPATABILITY8TABLE-E.1OPERATIONALHAZARDS表格E-1操作危害性8FUNCTION功能8USEERROR使用误差9TABLE-E.1-INFOMATIONHAZARDS表格E-19LABELING标号9OPERATATINGINSTRUCTIONS操作使用说明10WARNINGS警告11TABLE-E.2INITIATINGEVENTSANDCIRCUMSTANCES表格E-2启动结果与环境12INCOMPLETEREQUIREMENTS:不完全12MANUFACTURINGPROCESSES生产程序12TRANSPORTANDSTORAGE运输和储存13ENVIROMANTALFACTORS环境因素13CLEANING,DISENFECTING,ANDSTERIALIZATION14DISPOSALANDSCRAPPING处理和报废14FORMULATION简要表述15HUMANFACTORS人为因素15FAILUREMODES故障模式18Conclusion:结论19TobecompletedperinstructionsSOP-XX-XXRiskManagement,currentrevision,inconjunctionwithstandardISO14971andMDD93/42/EEC对于完成的标准操作程序中的风险管理和近期修正中的每项说明都应与标准的ISO14971以及MDD93/42/EEC保持一致Note:ALLBoxesinmatrixmusthaveanentrywhetherapplicableornot.注：所有的方框，必须要做登记适用与否(UseN/Aforboxeswhicharenotapplicable,TheACTIONTAKENBoxmustbefilledoutforanexplanation“WhyitisnotApplicable”)(使用N/A来判定方框哪个是不适用的。采用的方框必须填写明确的解释，“为什么不能用”)Sheet3of19PROBABILITYOFOCCURRENCE发生的可能性PROBABILITYRANGE概率等级DESCRIPTION描述FREQUENT发生频繁10-3OCCURRINGOFTENORREPEATEDLY经常发生或反复发生PROBABLE很可能的10-4REASONABLYLIKELYTOOCCUR有时候可能发生OCCASIONAL偶发的10-5IRREGULAROCCURRENCE,INFREQUENT不规律发生，不常见的REMOTE很少发生的10-6NOTLIKELYTOOCCUR不可能发生IMPROBABLE不可能的10-6UNLIKELYTOEVEROCCUR不大可能发生SEVERITY严重程度DESCRIPTION描述CATASTROPHIC致命的RESULTSINPATIENTDEATH导致患者死亡CRITICAL危险的RESULTSINPERMANENTIMPAIRMENTORLIFE-THREATENINGINJURY导致永久性损伤或危及生命的伤害SERIOUS严重的RESULTSININJURYORIMPAIRMENTREQUIRINGPROFESSIONALMEDICALINTERVENTION导致伤害或需要医务人员介入MINOR次要的LOWRISKFAILURENOTEXPECTEDTOCONTRIBUTETOANINJURY比较低的风险故障对之造成的伤害不可预知NEGLIGIBLE微小的INSIGNIFICANTFAILURENOTSERIOUSENOUGHTOCONTRIBUTETOANINJURY可以忽略的故障不足以促成严重伤害Sheet4of19PROBABILITYOFOCCURRENCE发生的可能性SEVERITYCATEGORIES严重程度分类NEGLIGIBLE忽略不计MINOR次要SERIOUS严重CRITICAL危险临界CATASTROPHIC致命FREQUENT频繁147531PROBABLE可能169752OCCASIONAL偶发1812964REMOTE很少191513118IMPROBABLE不可能2017151310HAZARDRISKINDEX危险指数ACCEPTANCECRITERIA接受标准1TO5UNACCEPTABLE不能接受6TO9UNDESIRABLE.WRITTEN&REVIEWEDDECISIONTOPROCEED著明不合格或需要进一步审核10TO16ACCEPTABLEUPONCOMPLETIONOFQUALITY可接受的在质量达标上线ASSURANCE/REGULATORYREVIEW保险但要调制审核17TO20ACCEPTABLEWITHOUTREVIEW合格不需要审查Sheet5of19Examplesofhazards,foreseeablesequencesofeventsandhazardoussituationsfromENISO14971:2007AnnexE危险的例子，可预测事情进展以及危险情况-TABLE-E.1一ENERGYHAZARDS电磁波危害ELECTROMAGNETICENERGY电磁兼容性HAZARD危害因素APPLIC适用的ABLTENTIALFAILURE潜在故障CAUSEOFFAILURE故障原因EFFECTSOFFAILURE故障影响RESPONSE反应RISKINDEX危险指数ACTIONTAKEN采用的措施LineVoltage线路电压YesNo11Design设计Label标签EnclosureLeakagecurrent附件漏电YesNoDesignLabelEarthLeakagecurrent接地漏电YesNoDesignLabelPatientLeakagecurrent耐漏电=YesNo=DesignLabelElectricFields电场YesNoDesignLabelMagneticFields磁场YesNoDesignLabelRADIATIONENERGY电磁波辐射HAZARDAPPLICAlpotentialBAiLureCAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENIonizingradiation致电离辐射YesNoDesignLabelNon-ionizingradiation非电离辐射YesNoDesignLabelSheet6of19MECHANICALENERGYHAZARDAPPLICABOENTIALCAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENGravity-Falling地心引力-下落=YesNo=DesignLabelGravitysuspendedmasses地心引力被悬浮的质量YesNoDesignLabelVibration振动YesNoDesignLabelStoredEnergy储存的能量YesNoDesignLabelMovingParts移动的部件=YesNo=DesignLabelTorsion,shearandtensileforceYesNoDesignLabelMovingandpositioningofpatient患者移动和转动YesNoDesignLabelAcousticenergy-ultrasonicenergy声能-超声波能量YesNoDesignLabelAcousticenergy-infrasoundenergy超低声波能=YesNo=DesignLabelAcousticenergy-sound声音YesNoDesignLabelHighpressurefluidinjection高压液体注入=YesNo=DesignLabelSheet7of19TABLE-E.1一BIOLOGICALANDCHEMICALHAZARDS生物化学危害BIOLOGICAL生物学的HAZARDAPPLICABOTEntialABAEureCAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENBacter