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,shallbeminimisedandbeacceptablewhenweighedagainsttheevaluatedbenefitsto
17、thepatientand/oruserarisingfromtheachievedperformanceofthedeviceduringnormalconditionsofuse.8.与正常使用条件下器械预期性能对患者和/或使用者产生的潜在益处相比,所有已知和可预见的风险及任何不良影响应最小化并控制在可接受范围内。9.ForthedevicesreferredtoinAnnexXVI,thegeneralsafetyrequirementssetoutinSections1and8shallbeunderstoodtomeanthatthedevice,whenusedundertheco
18、nditionsandforthepurposesintended,doesnotpresentariskatallorpresentsariskthatisnomorethanthemaximumacceptableriskrelatedtotheproduct,susewhichisconsistentwithahighlevelofprotectionforthesafetyandhealthofpersons.9.对于在附录十六中所列出的,制造商未声称用于医疗目的之器械,应充分了解在第1节和第8节规定的通用安全要求,即在预期条件下出于预期目的而使用器械时,器械不得出现任何风险,或出现不
19、超过与产品使用相关的最大可接受风险,这符合高水平保障人员安全和健康原则一致。CHAPTERIlREQUIREMENTSREGARDINGDESIGNANDMANUFACTURE第2章设计和生产相关要求10.Chemical,physicalandbiologicalproperties10化学、物理和生物学特性10.1.DevicesshallbedesignedandmanufacturedinsuchawayastoensurethatthecharacteristicsandperformancerequirementsreferredtoinChapterIarefulfilled.P
20、articularattentionshallbepaidto:器械的设计和生产应当能确保符合第I章中所述的特性和性能要求。特别注意:(a) thechoiceofmaterialsandsubstancesused,particularlyasregardstoxicityand,whererelevat,flammability;使用材料和物质的选择,特别是毒性和易燃性(如适用)(b) thecompatibilitybetweenthematerialsandsubstancesusedandbiologicaltissues,cellsandbodyfluids,takingaccou
21、ntoftheintendedpurposeofthedeviceand,whererelevant,absorption,distribution,metabolismandexcretion;所使用材料和物质与生物组织,细胞及体液间的相容性,及考虑到器械使用目的及相关的吸收、分布、新陈代谢和排泄;(c) thecompatibilitybetweenthedifferentpartsofadevicewhichconsistsofmorethanoneimplantablepart;器械不同部件之间的兼容性,该器械由多个可植入部件组成;(d)theimpactofprocessesonma
22、terialPrOPerties;过程对材料性能的影响;(e)whereappropriate,theresultsofbiophysicalormodellingresearchthevalidityofwhichhasbeendemonstratedbeforehand;若适用,生物物理学或建模研究结果有效性已事先获得证实;(f) themechanicalpropertiesofthematerialsused,reflecting,whereappropriate,matterssuchasstregth,ductility,fractureresistance,wearresista
23、nceandfatigueresistance;所使用材料的机械性能,在适当情况下反映诸如强度、延展性、抗断裂性、耐磨性和耐疲劳强度等问题;(g) surfaceproperties;and表面活性;(h) theconfirmationthatthedevicemeetsanydefinedchemicaland/orphysicalSPeCifiCationS.确认该器械满足任何确定的化学和/或物理要求。10.2.Devicesshallbedesigned,manufacturedandpackagedinsuchawayastominimisetheriskposedbycontami
24、nantsandresiduestopatients,takingaccountoftheintendedpurposeofthedevice,andtothepersonsinvolvedinthetransport,storageanduseofthedevices.Particularattentionshallbepaidtotissuesexposedtothosecontaminantsandresiduesandtothedurationandfrequencyofexposure.器械的设计、生产和包装应尽可能降低污染物和残留物对患者造成的风险,同时考虑到器械预期用途以及参与器
25、械运输、储存和使用的人员。应当特别注意暴露于这些污染物和残留物的组织以及暴露时间与频率。10.3.Devicesshallbedesignedandmanufacturedinsuchawaythattheycanbeusedsafelywiththematerialsandsubstances,includinggases,withwhichtheyenterintocontactduringtheirintendeduse;ifthedevicesareintendedtoadministermedicinalproductstheyshallbedesignedandmanufactur
26、edinsuchawayastobecompatiblewiththemedicinalproductsconcernedinaccordancewiththeprovisionsandrestrictionsgoverningthosemedicinalproductsandthattheperformanceofboththemedicinalproductsandofthedevicesismaintainedinaccordancewiththeirrespectiveindicationsandintendeduse.器械的设计和生产应以能使其可安全地与材料和物质(包括气体)一起使用
27、且在预期使用时,这些材料和物质会与器械接触;若器械预期用于管理医疗产品,根据管理这些医疗产品的条款和限制,则其设计和生产应使其能够与相关的医疗产品兼容,并应可根据其相应的指示和预期用途维护医疗产品和器械的性能。10.4.Substances物质10.4.1.Designandmanufactureofdevices器械的设计和生产substancesorparticles,includingweardebris,degradationproductsandprocessingresidues,thatmaybereleasedfromthedevice.器械的设计和生产应尽可能降低由物质或微
28、粒(包括磨屑、降解产物和加工残留物)造成的风险,而此类物质或微粒可能由器械产生。Devices,orthosepartsthereoforthosematerialsusedthereinthat:器械或其部件或其使用的材料:areinvasiveandcomeintodirectcontactwiththehumanbody,一(re)admiistermedicines,bodyliquidsorothersubstances,includinggases,to/fromthebody,or一transportorstoresuchmedicines,bodyfluidsorsubstan
29、ces,includinggases,tobe(re)admiisteredtothebody,shallonlycontainthefollowingsubstancesinaconcentrationthatisabove0,1%weightbyweight(ww)wherejustifiedpursuanttoSection10.4.2:-具有侵入性,并与人体直接接触,或-(重新)为人体输送药物、体液或其他物质(包括气体),或运输或储存待(重新)为人体输送药物、体液或物质(包括气体),在根据第10.4.2节进行调整时,应仅包含浓度高于0.1%重量比的以下物质:(八)substaceswh
30、icharecarcinogenic,mutagenicortoxictoreproduction(,CMR,),ofcategoryIAorIB,inaccordancewithPart3ofAnnexVltoRegulation(EC)No1272/2008oftheEuropeanParliamentandoftheCouncil(1),orIA或IB类有致癌、致突变或生育毒性(CMR)的物质,依据欧洲议会和理事会第1272/2008号法规附录VI第3部分判断,或(b)substanceshavingendocrine-disruptingpropertiesforwhichtherei
31、sscientificevidenceofprobableseriouseffectstohumanhealthandwhichareidentifiedeitherinaccordancewiththeproceduresetoutinArticle59ofRegulation(EC)No1907/2006oftheEuropeanParliamentandoftheCouncil(2)or,onceadelegatedacthasbeenadoptedbytheCommissionpursuanttothefirstsubparagraphofArticle5(3)ofRegulation
32、EU)No528/2012oftheEuropeanParliamentandtheCouncil(3),in有科学证据证明可能对人类健康造成严重影响的具有内分泌干扰性质的物质,根据欧洲议会和理事会第1907/2006号法规(?)第59条规定程序识别,或者委员会根据欧洲议会和理事会第528/2012号法规I)第5(3)条第一段通过授权法案后,根据本法规规定之与人类健康相关准则识别。1. .4.2.JustificationregardingthepresenceofCMRand/orendocrine-disruptingsubstancesThejustificationforthepre
33、senceofsuchsubstancesshallbebasedupon:10. 4.2关于存在CMR和/或内分泌干扰物的理由,存在此类物质的理由应基于:(a) ananalysisandestimationofpotentialpatientoruserexposuretothesubstance;(b) ananalysisofpossiblealternativesubstances,materialsordesigns,including,whereavailable,informationaboutindependentresearch,peer-reviewedstudies,s
34、cientificopinionsfromrelevantscientificcommitteesandananalysisoftheavailabilityofsuchalternatives;(c) argumentationastowhypossiblesubstanceand/ormaterialsubstitutes,ifavailable,ordesignchanges,iffeasible,areinappropriateinrelationtomaintainingthefunctionality,performanceandthebenefit-riskratiosofthe
35、product;includingtakingintoaccountiftheintendeduseofsuchdevicesincludestreatmentofchildrenortreatmentofpregnantorbreastfeedingwomenortreatmentofotherpatientgroupsconsideredparticularlyvulnerabletosuchsubstancesand/ormaterials;and(d) whereapplicableandavailable,thelatestrelevantscientificcommitteegui
36、delinesinaccordancewithSections10.4.3.and10.4.4.(八)对潜在患者或使用者暴露于该物质下情况进行分析和判断;(b)对可能的替代物质、材料或设计进行的分析,(在可用时)包括有关独立研究、同等评审研究、相关科学委员会的科学意见等信息,以及对这些替代品可用性的分析;(C)论证可能的物质和/或材料替代品(如有)或设计变更(如可行)不适用于维护产品功能、性能和利益-风险比的原因;包括要考虑这些器械的预期用途是否包括儿童治疗,或孕妇或哺乳妇女治疗,或对其他特别容易受到此类物质和/或材料影响的患者群体的治疗;(d)如适用和可用时,基于根据第10.4.3节和10.
37、4.4.节制定的最新相关的科学委员会指南。10.4.3.Guidelinesonphthalates10.4.3邻苯二甲酸酯使用指南ForthepurposesofSection10.4.,theCommissionshall,assoonaspossibleandby26May2018,providetherelevantscientificcommitteewithamandatetoprepareguidelinesthatshallbereadybefore26May2020.Themandateforthecommitteeshallencompassatleastabenefit-
38、riskassessmentofthepresenceofphthalateswhichbelongtoeitherofthegroupsofsubstancesreferredtoinpoints(八)and(b)ofSection10.4.1.Thebenefit-riskassessmentshalltakeintoaccounttheintendedpurposeandcontextoftheuseofthedevice,aswellasanyavailablealternativesubstancesandalternativematerials,designsormedicaltr
39、eatments.Whendeemedappropriate为达到本附录第104条的目的,委员会应尽快并于2018年5月26日向相关科学委员会提供任务以制定指南,且本指南应在2020年5月26日前编制好。委员会的任务至少应包含对邻苯二甲酸酯存在的利益风险评价,其中邻苯二甲酸酯属于第10.4.1节要点(八)和(b)中所所述物质组中的任何一组。利益风险评价应考虑器械、可用替代物质和替代材料、设计和/或药物治疗使用的预期目的和环境。虽然根据最新科学证据认为是适当的,但应至少每五年更新一次本指南。(1) Regulation(EC)No1272/2008oftheEuropeanParliamenta
40、ndoftheCouncilof16December2008onclassification,labellingandpackagingofsubstancesandmixtures,amendingandrepealingDirectives67/548/EECand1999/45/EC,andamendingRegulation(EC)No1907/2006(OJL353,31.12.2008,p.1).(2) Regulation(EC)No1907/2006oftheEuropeanParliamentandoftheCouncilof18December2006concerningt
41、heRegistration1EvaIuation,AuthorisationandRestrictionofChemicals(REACH)(OJL396,30.12.2006,p.1).(3) Regulation(EU)No528/2012oftheEuropeanParliamentandthe(1)欧洲议会和理事会于2008年12月16日签发的关于物质和混合物分类、标签和包装的第1272/2008号法规,修订和废除第67/548/EEC号指令和第1999/45/EC号指令,并修订了第1907/2006号法规(OJL353,31.12.2008,p.1)。(2)欧洲议会和理事会于200
42、6年12月18日签发的关于化学品注册、评价、授权和限制(REACH)的第1907/2006号法规(OJL396,30.12.2006,p.(3)欧洲议会和理事会于2012年5月22日签发的关于在市场上提供和使用杀生物产品的第528/2012号法规(OJL167,27.06.2012,p.1)。Do10.4.4GuideliesonotherCMRandendocrine-disruptingsubstances其他CMR和内分泌干扰物质的指南Subsequently,theCommissionshallmandatetherelevantscientificcommitteetoprepare
43、guidelinesasreferredtoinSection10.4.3.alsoforothersubstancesreferredtoinpoints(八)and(b)ofSection10.4.1.,whereappropriate.随后,委员会应授权相关科学委员会按照第107.4.3中所述的要求,也为第10.4.1节要点(八)和(b)中所所述的其他物质制定指南。10.4.5Labelling贝占标Wheredevices,partsthereoformaterialsusedthereinasreferredtoinSection10.4.1.containsubstancesref
44、erredtoinpoints(八)or(b)ofSection10.4.1.inaconcentrationabove0,1%weightbyweight(ww),thepresenceofthosesubstancesshallbelabelledonthedeviceitselfand/oronthepackagingforeachunitor,whereappropriate,onthesalespackaging,withthelistofsuchsubstances.Iftheintendeduseofsuchdevicesincludestreatmentofchildrenor
45、treatmentofpregnantorbreastfeedingwomenortreatmentofotherpatientgroupsconsideredparticularlyvulnerabletosuchsubstancesand/ormaterials,informationonresidualrisksforthosepatientgroups按照第10.4.1节所述的要求,若此中所使用的器械、其部件或材料,包含第10.4.1节中所述的浓度高于0.1%重量比的物质,则应在器械本身和/或各单元的包装上或,(适当时)在销售包装上把此类物质清单标识清楚。若此类器械的预期用途,包括儿童
46、治疗,或孕妇或哺乳妇女治疗,或对视为特别易受到此类物质和/或材料影响的其他患者群体的治疗,则关于这些患者群体的剩余风险、(如适用)预防措施信息,均应在使用说明中给出。10.5.Devicesshallbedesignedandmanufacturedinsuchawayastoreduceasfaraspossibletherisksposedbytheunintentionalingressofsubstancesintothedevicetakingintoaccountthedeviceandthenatureoftheenvironmentinwhichitisintendedtobe
47、used.必须合理设计及生产器械,以尽量降低因物质意外进入器械而造成的风险,并且应考虑到器械及其预期使用环境的性质。10.6.Devicesshallbedesignedandmanufacturedinsuchawayastoreduceasfaraspossibletheriskslinkedtothesizeandthepropertiesofparticleswhichareorcanbereleasedintothepatientsorusersbody,unlesstheycomeintocontactwithintactskinonly.Specialattentionshall
48、begiventoaomaterials.器械的设计和生产应尽可能减少与微粒尺寸和性能相关的风险,除非这些微粒接触到的是完好的皮肤,否则这些微粒会位于或可释放到患者或使用者体内。应特别注意纳米材料。11.Infectionandmicrobialcontamination感染及微生物污染11.1. Devicesandtheirmanufacturingprocessesshallbedesignedinsuchawayastoeliminateortoreduceasfaraspossibletheriskofinfectiontopatients,usersand,whereapplicable,otherpersons.Thedesignshall:(a) reduceasfaraspossiblean