ISO14971-2007-风险管理报告模板-中英对照

RiskManagementReportNo.RM-(Project#)-00xSheetTABLE-E.1–ENERGYHAZARDS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.1–BIOLOGICALANDCHEMICALHAZARDS表格E-1生化危害性 7BIOLOGICAL生物学制品 7CHEMICAL化学制品 7BIOCOMPATABILITY 8TABLE-E.1–OPERATIONALHAZARDS表格E-1操作危害性 8FUNCTION功能 8USEERROR使用误差 9TABLE-E.1–INFOMATIONHAZARDS表格E-1 9LABELING标号 9OPERATATINGINSTRUCTIONS操作使用说明 10WARNINGS警告 11TABLE-E.2–INITIATINGEVENTSANDCIRCUMSTANCES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,andsterialization 14disposalandscrapping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”）

PROBABILITYOFOCCURRENCE发生的可能性Probability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<10-3and≥10-4REASONABLYLIKELYTOOCCUR有时候可能发生OCCASIONAL偶发的<10-4and≥10-5IRREGULAROCCURRENCE,INFREQUENT不规律发生，不常见的REMOTE很少发生的<10-5and≥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PROBABILITYOFOCCURRENCE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

Examplesofhazards,foreseeablesequencesofeventsandhazardoussituations[fromENISO14971:2007AnnexE]危险的例子,可预测事情进展以及危险情况TABLE-E.1–ENERGYHAZARDS 电磁波危害ELECTROMAGNETICENERGY 电磁兼容性HAZARD危害因素APPLICABLE适用的POTENTIALFAILURE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FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesign设计FORMCHECKBOXLabel标签EnclosureLeakagecurrent附件漏电FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelEarthLeakagecurrent接地漏电FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelPatientLeakagecurrent耐漏电FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelElectricFields电场FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelMagneticFields磁场FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelRADIATIONENERGY 电磁波辐射HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENIonizingradiation致电离辐射FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelNon-ionizingradiation非电离辐射FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelMECHANICALENERGYHAZARDAPPLICABLEPOTENTIALFAILURCAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENGravity-Falling地心引力-下落FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelGravity–suspendedmasses地心引力被悬浮的质量FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelVibration振动FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelStoredEnergy储存的能量FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelMovingParts移动的部件FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelTorsion,shearandtensileforceFORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelMovingandpositioningofpatient患者移动和转动FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelAcousticenergy-ultrasonicenergy声能-超声波能量FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelAcousticenergy-infrasoundenergy超低声波能FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelAcousticenergy-sound声音FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelHighpressurefluidinjection高压液体注入FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelTABLE-E.1–BIOLOGICALANDCHEMICALHAZARDS 生物化学危害BIOLOGICAL 生物学的HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENBacteria细菌FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelViruses病毒FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelOtheragents(e.g.poisons)其它FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelRe-orcross-infection交差感染FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelCHEMICAL:Exposureofairway,tissues,environmentorpropertye.g.toforeignmaterials化学因素：导气管暴露、组织、环境、外来材料HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENAcidsoralkalis酸碱FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelResidues残留物FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelContaminants污染物FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelAddictivesorprocessingaids加工助剂FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelCleaning,disinfectingortestingagents清洁消毒或检测制剂FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelDegradationproducts降解产物FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelMedicalgasses医疗气体FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelAnestheticproducts麻醉制剂FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelBIOCOMPATABILITY,Toxicityofchemicalconstituents,e.g. 化学毒性成分HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENAllergenicity/irritancy过敏性/刺激FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelPyrogenicity(inducefever)发热性(导致发烧)FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelTABLE-E.1–OPERATIONALHAZARDS 操作危害FUNCTION 功能HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENIncorrectorinappropriateoutputorfunctionality不正确或不适当的输出或功能性FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelIncorrectmeasurement不正确测量FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelErroneousdatatransfer错误资料传递FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelLossordeteriorationoffunction功能丧失或恶化FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelUSEERROR 使用错误HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENAttentionalfailure保养不当FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelMemoryfailure记忆故障FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelRule-basedfailure设立基准规则故障FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelKnowledge-basedfailure系统故障FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelRoutineViolation违反常规FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelTABLE-E.1–INFOMATIONHAZARDS 信息危害LABELING 标签HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENIncompleteinstructionsforuse不完全按照使用说明书操作FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelInadequatedescriptionofperformancecharacteristics不完整的工作特性说明书FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelInadequatespecificationofaccessoriestobeusedwiththemedicaldevice用于医疗器械的附件说明书不完整FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelInadequatedisclosureoflimitations有限的改进但不完整FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelOPERATATINGINSTRUCTIONS 操作说明HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENInadequatespecificationofaccessoriestobeusedwiththemedicaldevice用于医疗器械的附件说明书不完整FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelInadequatespecificationofpre-usechecks预先使用FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelOver-complicatedoperatinginstructions过于复杂的操作说明书FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelWARNINGS 警告HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENWarningsofsideeffects副作用的警告FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelWarningsofhazardslikelywithre-useofsingle-usemedicaldevices危险警示可能与单纯重复使用医疗设备有关FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelSPECIFICATIONOFSERVICEANDMAINTENANCE 维护保养说明HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENInadequatespecificationofwhenserviceandmaintenanceisrequired当需要维护保养时，说明书不详尽FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelTABLE-E.2–INITIATINGEVENTSANDCIRCUMSTANCES 启动结果INCOMPLETEREQUIREMENTS,InadequateSpecificationof: 不完全要求，不充分的说明：HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENDesignparameters设计参数FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelOperatingparameters操作参数FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelPerformancerequirements性能要求FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelIn-servicerequirements(e.g.maintenance,reprocessing)运行中要求（维护，重复处理）FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelEndoflife保质期结束FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelMANUFACTURINGPROCESSES,Insufficientcontrolof: 产品处理程序，没有完全控制:HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENChangestomanufacturingprocess改变产品的程序FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelMaterials/materialscompatibilityinformation材料兼容性报告FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelManufacturingprocesses生产程序FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelSubcontractors次承包商FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelTRANSPORTANDSTORAGE 运输和储存HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENInadequatepackaging不适当包装FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelContaminationordeterioration污染或变质FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelInappropriateenvironmentalconditions不良的环境条件FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelENVIROMANTALFACTORS 环境因素HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENPhysical(e.g.heat,pressure,time)物理上的（热，压力，时间）FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelChemical(e.g.cocorrosions,degradation,contamination)化学上的（腐蚀，变质，污染）FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelElectromagneticfields(e.g.susceptibilitytoelectromagneticdisturbance)电磁场（易受电磁干扰）FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelInadequatesupplyofpower能量不能充分供应FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelInadequatesupplyofcoolant冷却剂不能充分供应FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelcleaning,disenfecting,andsterializationHAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENLackof,orinadequatespecificationfor,validatedproceduresforcleaning,disinfectingandsterilization.缺乏或对有效性没有充分的说明，对清洁消毒杀菌过程没有充分说明FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelInadequateconductforcleaning,disinfectingandsterilization没有对清洁消毒杀菌进行充分的指导FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabeldisposalandscrapping 处理和报废HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENNo,orinadequateinformationprovided.提供不准确的信息FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelUseerror使用误差FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelFormulation 明确地表达HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENBiodegrationFORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelBiocompatibility生物适应性FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelNoInformationorinadequatespecificationprovided没有提供信息或充分说明FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelInadequatewarningsofhazardsassociatedwithincorrectformulations不充分的危险警告与不正确的表达FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelUseerror使用误差FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelhumanfactors,Potentialforuseerrorstriggeredbydesignflaws,suchas:人为因素，设计缺陷而引起可能使用误差HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENConfusingormissinginstructionsforuse使用说明书使用不当或丢失FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelComplexorconfusingcontrolsystem复杂或混乱的控制系统FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelAmbiguousoruncleardevicestate含混不清的设计说明FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelAmbiguousorunclearpresentationofsettings,measurementsorotherinformation设置说明，尺寸或其它介绍含混不清FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelMisrepresentationofresults结果误报FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelInsufficientvisibility,audibilityoftactility触感的可见度，可听度不够FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelPoormappingofcontrolstoactions,orofdisplayedinformationtoactualstate对具体的情态信息显示，对动作的控制影象都很差FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelControversialmodesormappingascomparedtoexistingequipment与现有的装置相比，模式和影象都有争议FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelUsebyunskilled/untrainedpersonnel设备由不熟练和没有培训过的人员来操控FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelInsufficientwarningsofsideeffects副作用的警告不够完备FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelInadequatewarningsofhazardsassociatedwithre-useofsingle-usemedicaldevices不适当的警告拌有单一反复使用医疗设备FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelIncorrectmeasurementandothermetrologicalaspects.不正确的尺寸和其它计量方法FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelIncompatibilitywithconsumables/accessories/othermedicaldevices与耗材，附件或其它医疗设备不相容FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelSlip,lapsandmistakes错误FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelfailuremodes 错误模式HAZARDAPPLICABLEPOTENTIALFAILURECAUSEOFFAILUREEFFECTSOFFAILURERESPONSERISKINDEXACTIONTAKENUnexpectedlossofelectrical/mechanicalintegrity电气机械完善的不可预测的损耗FORMCHECKBOXYesFORMCHECKBOXNoFORMCHECKBOXDesignFORMCHECKBOXLabelDeteriorationinfunction(e.g.gradualocclusionoffluid/gaspath,orchangeinresistancetoflow,electricalconduct