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MDR AnnexI附录一General safety and performance requirements Checklist通用安全和性能要求检查表Applica LocationEvidencecomplianceGeneral safety and performancerequirements or reasonblity适用Standards Used应用标准for noapplicability符合性证据-section位置-章通用安全和性能要求或不适用迪由性节第章一般要求CHAPTER1GENERAL REQUIREMENTS
11.Devices shallachieve the performance intended by theirmanufacturer and shall bedesigned and manufactured in such a way that,during normalconditions of use,theyare suitable for their intended purpose.They shall be safe and effective and shallnotcompromise the clinical conditionor the safety of patients,or the safety andhealth ofusersor,where applicable,other persons,provided that any risks which may beassociated with their useconstitute acceptablerisks whenweighed againstthe benefitsto the patientand arecompatible with a high.
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.The requirement in thisAnnex toreduce risks as far as possiblemeans thereductionof risksas far as possiblewithout adverselyaffecting the benefit-risk ratio.
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.Manufacturers shallestablish,implement,document andmaintain a riskmanagement system.如适用和可用时,基于根据第节和节制定的最新相关的科学委员会指d
10.
4.
4.南邻苯二甲酸酯使用指南.Guidelines onphthalatesFor the purposes of Section
10.
4.,the Commissionshall,as soonas possible and by26May2018,provide the relevant scientific committee with a mandateto prepareguidelinesthat shall be readybefore26May
2020.The mandatefor thecommitteeshall encompassat leasta benefit-risk assessmentof the presence ofphthalates whichbelongto either of thegroups of substances referred to in points a and b of Section
10.
4.
1.The benefit-risk assessmentshall takeinto account the intended purpose andcontextof the use of the device,as wellas anyavailable alternativesubstances andalternativematerials,designs ormedical treatments.When deemedappropriate为达到本附录第条的目的,委员会应尽快并于年月日向相关科
10.42018526学委员会提供任务以制定指南,且本指南应在年月日前编制好委员会的2020526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节要点和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a b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1Regulation EC No1272/2008of theEuropean Parliament and of the Councilof16December2008on classification,labelling andpackaging of substances andmixtures,amending andrepealing Directives67/548/EEC and1999/45/EC,and amendingRegulation ECNo1907/2006OJ L353,
31.
12.2008,p.
1.2Regulation ECNo1907/2006of theEuropean Parliamentand of the Councilof18December2006concerning theRegistration.Evaluation,Authorisation andRestriction ofChemicalsREACH OJ L396,
30.
12.2006,p.
1.3Regulation EU No528/2012of theEuropean Parliamentand the欧洲议会和理事会于年月日签发的关于物质和混合物分类、标签和包装的第号法规,修订和废除第号指令和第号指令,并1200812161272/200867/548/EEC1999/45/EC修订了第号法规1907/20060J L353,
31.
12.2008,p.1«欧洲议会和理事会于年月日签发的关于化学品注册、评价、授权和限制的第号法规欧洲议会和理事会于220061218REACH1907/2006OJ L396,
30.
12.2006,p.Do3年月日签发的关于在市场上提供和使用杀生物产品的第号法规2012522528/2012OJ L167,
27.
06.2012,p.
110.
4.4Guidelines onother CMRand endocrine-disrupting substances其他和内分泌干扰物质的指南CMRSubsequently,the Commissionshall mandate therelevant scientificcommitteetoprepare guidelinesas referred to inSection
10.
4.
3.also for other substancesreferredto in points aand bof Section
10.
4.
1.,where appropriate.随后,委员会应授权相关科学委员会按照第中所述的要求,也为第节要点
107.
4.3a和中所所述的其他物质制定指南b贴标LabellingWhere devices,parts thereofor materials used therein as referred to inSection
10.
4.
1.contain substancesreferred to inpoints a orbof Section
10.
4.
1.in aconcentrationabove0,1%weight byweight w/w,the presence of thosesubstancesshall belabelled on the device itself and/or on the packagingfor eachunit or,whereappropriate,on thesales packaging,with thelist of such substances.If the intendeduse of such devices includes treatmentof childrenor treatmentof pregnant orbreastfeeding womenor treatmentof otherpatient groupsconsidered particularlyvulnerableto such substances and/or materials,information onresidual risks for thosepatientgroups按照第节所述的要求,若此中所使用的器械、其部件或材料,包含第
10.
4.
110.
4.1节中所述的浓度高于重量比的物质,则应在器械本身和/或各单元的包装上或,
0.1%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.Devices shall be designed and manufactured in such a way as toreduce as far aspossible the risksposed by the unintentionalingress of substances into thedevice taking into account the device and the nature of the environmentin which it isintended to be 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.Devices shall be designed and manufactured in such a way as toreduce as far aspossible the riskslinked to the size and theproperties ofparticles which are orcan bereleasedinto the patients or users body,unless theycome into contact withintact skinonly.Special attentionshall be given tonanomaterials.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.Infection andmicrobial contamination感染及微生物污染
11.
1.Devices and their manufacturing processes shall be designedin such a wayas to eliminate or toreduce as far as possiblethe risk ofinfection to patients,usersand,where applicable,other persons.The designshall:a reduce as far as possibleand appropriatethe risksfrom unintendedcuts andpricks,such asneedle stickinjuries,ballow easyand safehandling,c reduce as far as possibleany microbialleakage from the device and/or microbialexposureduring use,andd preventmicrobial contaminationof the device orits contentsuch asspecimensor fluids.器械和生产过程的设计应尽可能消除或减少感染患者、使用者和适用时其他人的风险设计应尽可能减少并消除意外由于切割和刺破造成的风险,例如针刺损伤;a使用便捷安全;b尽可能降低器械的微生物泄漏和/或使用过程中的微生物暴露;c防止器械或其所包含之物例如样本或液体受到微生物的污染d
11.
2.Where necessarydevices shall be designed to facilitate their safecleaning,disinfection,and/orre-sterilisation.必要时,应将器械设计成便于进行安全清洁、消毒和/或再灭菌
11.
3.Devices labelledas havinga specificmicrobial stateshall be designed,manufactured and packaged to ensure that they remainin thatstate whenplaced onthe market andremain sounder the transport and storage conditions specified by themanufacturer.应对标记为具有特殊微生物种群的器械进行设计、生产和包装,以确保在投放到市场时,及在制造商规定的运输和储存条件下,器械依旧保持原样
11.
4.Devices deliveredina sterile stateshall be designed,manufactured andpackaged in accordance with appropriateprocedures,to ensure that theyare sterilewhenplaced on the marketand that,unless the packaging whichis intended tomaintain theirsterile conditionis damaged,they remainsterile,under thetransportand storageconditionsspecifiedby the manufacturer,until that packaging isopened atthe point of use.It shall be ensuredthat the integrity of thatpackagingis clearlyevidentto thefinal user.应根据适当流程,对在无菌状态下运输的器械进行设计、生产和包装,以确保在投放到市场时,及在制造商指定的运输和储存条件下,器械能保持无菌状态,除非旨在保持其无菌状态的包装遭到损坏,仍保持无菌,直至保护包装破损或出于使用目的而打开时这些措施应确保最终使用者可清晰可见无菌包装的完整性
11.
5.Devices labelledas sterileshall beprocessed,manufactured,packaged and,sterilised by means of appropriate,validated methods.应通过适当的经过验证的处理、生产、包装和灭菌方法标识为无菌器械
11.
6.Devices intended to besterilised shall be manufactured andpackaged inappropriate and controlled conditionsand facilities.用于灭菌的器械应采用适当且可控条件和设备进行生产和包装
11.
7.Packaging systemsfor non-sterile devices shall maintain theintegrityandcleanliness of the productand,where the devices areto besterilised priorto use,minimise the risk ofmicrobial contamination;the packaging若器械在使用前灭菌,则非无菌器械的包装系统应保持产品的完整性和清洁度,
11.7以尽量减少微生物污染风险;此外,包装系统应适当考虑制造商指定的灭菌方法
11.
8.The labellingof the device shalldistinguish betweenidentical orsimilar devicesplaced on themarket inboth asterile anda non-sterile conditionadditional to thesymbol usedto indicatethat devices are sterile.器械标识除带有灭菌产品的指示符号外,还应可区别市场上相同或相似器械的
11.8灭菌和非灭菌状态
12.Devices incorporatinga substanceconsidered to be a medicinal productanddevices that are composed ofsubstances or of combinations ofsubstances that areabsorbed by or locally dispersed in the human body.包含被认为是药品物质的器械,及由人体吸收或局部喷洒在人体上的物质或物质12组合构成的器械
12.
1.In the case of devices referredto in the first subparagraph of Article18,thequality,safety andusefulness of the substancewhich,if usedseparately,would beconsideredto bea medicinalproduct within the meaningof point2of Article1ofDirective2001/83/EC,shall beverified byanalogy with the methodsspecified inAnnex1to Directive2001/83/EC,as requiredby theapplicable conformityassessmentprocedure underthis Regulation.对于第条第一子段所指的器械,若单独使用,则该物质的质量、安全性和
12.118可用性将被视为是符合第号指令第条点的医药产品,则应按照本法2001/83/EC12规中适用的符合性评价流程的规定,使用与第号指令附录所规定方法2001/83/EC I相似的方法进行验证
12.
2.Devices that are composed ofsubstances or of combinations ofsubstances thatare intended to be introduced into the human body,and that are absorbed by or locallydispersed in the humanbody shallcomply,where applicable and ina mannerlimited totheaspects notcovered by this Regulation,with therelevant requirementslaid downinAnnex1to Directive2001/83/EC for the evaluation of absorption,distribution,metabolism,excretion,local tolerance,toxicity,interaction with otherdevices,medicinal productsor othersubstances andpotential预期植入到人体,以及由人体吸收或局部喷洒在人体上的物质或物质组合构成
12.2的渊械,应遵从,适用时并受限于本法规与第号指令附录中规定的相2001/83/EC I关要求未涵盖方面,而这些相关要求用于按照本法规适用的符合性评价流程,对吸收、分配、新陈代谢、排泄、局部耐受性、毒性,与其他器械、医药产品呼呼其他物质和相互影响,及副作用的潜在影响进行评价
13.Devices incorporatingmaterials ofbiological origin.含有生物来源材料的器械
1313.
1.For devicesmanufactured utilisingderivatives oftissues orcells of humanorigin whichare non-viable orare rendered non-viable covered bythis Regulation in对于使用由本accordance withpoint gof Article16,the following shall apply:
13.1法规涵盖的非活性或处理为非活性人源生物组织或细胞生产成的器械,根据第条16点,适用以下规定ga donation,procurement andtesting of the tissues and cellsshall bedone inaccordance with Directive2004/23/EC;对用于器械生产的人源组织和细胞的捐赠、购买和测试应根据第号指令2004/23/EC完成b processing,preservation and any otherhandling of those tissuesand cellsortheir derivativesshall be carried out so as to provide safety for patients,users and,where applicable,other persons.In particular,safety with regard to viruses and othertransmissible agents shall be addressed byappropriate methods of sourcingand byimplementation of validatedmethods ofelimination or inactivation in the courseof the应对那些组织和细胞或其衍生物进行处理、保存和任何其他操manufacturing process;作,从而为患者、使用者、适用时其他人员提供安全保障特别是,应通过适当D的来源方法,以及通过在生产过程中实施经验证的消除或灭活方法处理与病毒和传染因子安全性相关的问题c the traceability systemfor thosedevices shall be complementaryand compatiblewith thetraceabilityand dataprotection requirementslaid downin Directive2004/23/EC and in Directive2002/98/EC.这些器械的可追溯体系应与第号指令和第号指令所规定可2004/23/EC2002/98/EC溯源性和数据保护要求是互补和相兼容
13.
2.For devicesmanufactured utilisingtissues orcells of animal origin,or theirderivatives,whicharenon-viable orrenderednon-viable the followingshallapply:a wherefeasible taking into account the animalspecies,tissuesandcells of animalorigin,or theirderivatives,shall originatefrom animalsthat have been subjected toveterinary controlsthat areadapted to the intended use of the tissues.Information onthegeographical originof theanimals shall be retainedby manufacturers;b sourcing,processing,preservation,testing andhandling oftissues,cells andsubstances of animal origin,or theirderivatives,shall becarried outso as to providesafetyfor patients,users and,where applicable,other persons.In particularsafetywith regard toviruses and other transmissible agentsshall beaddressed by implementationof validatedmethodsofelimination orviral inactivationin the courseof themanufacturing process,except when the use ofsuchmethodswould leadto unacceptabledegradation compromising theclinical benefit of thedevice;c inthe caseof devicesmanufactured utilisingtissues orcells of animal origin,ortheir derivatives,as referredto in Regulation EUNo722/2012the particularrequirementslaid downin thatRegulation shallapply.对于使用非活性或处理非活性动物源组织或细胞,或其衍生物生产的器械,应
13.2适用以下规定在可行的情况下,考虑到动物种类,动物源组织和细胞或其衍生物应来自己经a受兽医控制,即适合于组织预期使用的动物由制造商保留动物地理来源信息应获取动物源组织、细胞和物质或其衍生物,并对其进行处理、保存、测试和b操作,从而为患者、使用者和其他人员如适用提供安全保障特别是关于病毒和其他传播因子的安全性,应通过在生产过程中,实施经验证的消除或病毒灭活方法来解决,除非此类方法的使用会导致不可接受的降解,损害器械的临床益处在使用动物来源的组织或细胞或其衍生物生产的器械,如第号法规所c722/2012述,应适用该法规规定的特别要求
13.
3.For devicesmanufactured utilisingnon-viable biologicalsubstances otherthanthose referredto inSections
13.1and
13.2,the processing,preservation,testing andhandlingofthosesubstances shall becarriedoutsoas toprovidesafetyfor patients,users and,where applicable,other persons,including inthe wastedisposal chain.Inparticular,safety withregardtovirusesandothertransmissibleagentsshall beaddressedbyappropriate methodsof sourcingand byimplementationofvalidatedmethods ofelimination or inactivation inthe courseof themanufacturingprocess.对于使用其他非活性生物物质生产的器械,在第和节所述的情况下,应对
13.
113.2这些物质的进行加工、保存、测定和处理,以便为患者、使用者和其他人(如适用)提供安全性,包括整条废物处理链特别是,应通过适当的来源方法,及通过在生产过程中实施经验证的消除或失活方法处理与病毒和传染因子安全性相关的问题
14.Construction of devices andinteraction with their environment器械构造及其与环境之间的相互作用
14.
14.
1.If the device is intended for use incombination with other devices or equipmentthewhole combination.including theconnection systemshall besafeandshall notimpairthe specified performance of the devices.Any restrictionson useapplying tosuchcombinations shall be indicatedon the label and/or inthe instructions for use.Connections which the userhas tohandle,such asfluid,gas transfer,electrical ormechanicalcoupling,shall be designed andconstructed in such a way as to minimiseallpossible risks,such asmisconnection.若器械预定与其他潜械或设备一起配合使用,必须保证整个系统包括连接系统具有安全性,同时不得改变本器械的指定性能此类组合结构的任何使用限制应在标签和/或使用说明书上标明应以尽量减少所有可能的风险如误连接的方式设计和构造使用者必须处理的连接件,例如流体、气体输送、电气或机械联轴节
14.
2.Devices shall be designedand manufactured in such a way as to remove orreduceas faras possible:a therisk ofinjury,in connection with theirphysical features,including thevolume/pressure ratio,dimensional and where appropriateergonomic features;b risks connected withreasonably foreseeable external influences orenvironmental conditions,such asmagnetic fields,external electricalandelectromagnetic effects,electrostatic discharge,radiation associated with diagnosticortherapeutic procedures,pressure,humidity,temperature,variationsin pressureand accelerationor radiosignal interferences;cthe risksassociated with the use of the device whenit comesintocontact withmaterials,liquids,and substances,including gases,to whichit isexposed duringnormalconditions ofuse;dthe risksassociated with the possiblenegative interactionbetween softwareandthe ITenvironment within whichitoperates andinteracts;ethe risks of accidentalingress ofsubstances into the device;f the risksof reciprocal interferencewith other devices normallyused intheinvestigations orfor thetreatment given;andgrisks arisingwhere maintenanceor calibration are notpossible aswith implants,from ageing of materials used orloss of accuracy of any measuring or controlmechanism.应采用适当方式设计和生产溶械,确保尽可能地避免或减少以下内容与器械物理特征有关的伤害风险,包含体积/压力比、尺寸、和人体工程学特征a|如适用;与可合理预见的外部影响或环境条件相关的风险,例如磁场、外部电场和电磁b效应、静电放电、诊断或治疗过程的辐射、压力、湿度、温度、压力变化和压力加速或者无线电信号干扰;与该器械使用相关的风险,当其接触材料、液体和物质时,包括其在正常使用c条件下暴露接触的气体;与软件和环境间的可能负相互作用相关的风险,器械在该环境内操作和相d IT IT互作用;物质意外进入器械的风险;e⑴在研究中正常使用或给予治疗期间,与其他器械相互干扰造成的风险;由于下面原因导致的风险材料老化、测试或控制机能精准度下降而无法维修g或校正如植入人体后器械
14.
3.Devices shall be designedand manufactured in such a wayas tominimise
3.制造商应建立、实施、记录和维护风险管理体系Risk managementshall beunderstood asa continuousiterative processthroughout theentirelifecycle ofa device,requiring regularsystematic updating.In carryingout riskmanagementmanufacturers shall: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 establishand documentariskmanagement planfor eachdevice;制订并记录各器械的风险管理计划;b identify and analysethe known and foreseeablehazards associated with eachdevice;识别和分析与各器械相关的己知和可预见的危害;c estimateand evaluatethe risksassociatedwith,and occurringduring,the intendeduse and duringreasonably foreseeablemisuse;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 eliminateor controlthe risksreferredto inpointin accordance with therequirements ofSection4;根据第4节的要求消除或控制c点所述的这些风险;e evaluatethe impactof informationfrom theproduction phaseand,in particular,from thepost-market surveillancesystem,on hazardsand thefrequency ofoccurrencethereof,on estimatesof theirassociated risks,as wellas on the overallrisk,benefit-riskratio andrisk acceptability;and评估生产阶段,特别是上市后监管体系的信息、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 based on theevaluationof the impactof the information referredto inpoint e,ifnecessary amendcontrol measuresin line withthe requirementsofSectionthe risksof fireor explosionduring normal use andin singlefault condition.Particularattention shall be paid to devicesthe intended use of which includesexposure toor useinassociation withflammable orexplosive substancesor substanceswhich couldcausecombustion.必须适当地设计和生产器械,确保在正常使用期间和单一故障情形下尽量减少火灾或爆炸风险应特别留意此类器械其预期用途包括暴露于或与易燃易爆物质或可引燃物质结合使用的器械
14.
4.Devices shall be designedand manufacturedin sucha way that adjustment,calibration,and maintenancecan bedone safelyand effectively.器械的设计和生产应确保可安全且有效地进行调整、校准和维护
14.
5.Devices that are intended to beoperated together withother devices orproductsshall be designedand manufacturedin sucha way that the interoperabilityand用于与其他滞械或产品协同操作的器械设计和生产compatibility arereliable andsafe,应确保其互通性和兼容性可靠且安全
14.
6.Any measurement,monitoring ordisplay scaleshall be designed andmanufacturedin linewith ergonomic principles,taking accountof the intendedpurpose,users and the environmental conditions in which the devices are intended tobe used.应根据人体工程学原理设计和生产任何测量、监测或显示器标度的器械,且考虑到器械的预期用途、使用者以及器械预期使用所在的环境条件
14.
7.Devices shall be designedand manufacturedin sucha wayas tofacilitate theirsafe disposal and thesafedisposal ofrelated wastesubstances by the user,patient orother person.To thatend,manufacturers shallidentifyandtest proceduresandmeasures asa resultof which their devicescan besafely disposedafter use.Such应以此类方式设计和生procedures shall be describedinthe instructions for use.
14.7产器械,以便于使用者、患者或其他人安全处置器械和/或相关废物为此,制造商应研究并测试程序和措施,以便器械使用后可安全处置这些程序应在使用说明中给出色诂具有诊断或测定功能的器械
15.Devices with a diagnosticor measuring
31115.
1.Diagnostic devices and devices witha measuring function,shall be designed andmanufacturedin sucha wayas toprovide sufficientaccuracy,precision andstability fortheir intended purpose,based onappropriate scientificand technicalmethods.Thelimits ofaccuracy shall be indicatedby the manufacturer.应以此类方式设计和生产具有测定功能的诊断器械和器械,应根据适当的科学
15.1和技术方法为其预期用途提供足够的准确度、精度和稳定性准确度范围应由制造商指定
15.
2.The measurementsmade by devices withameasuring function shall beexpressed inlegal unitsconforming to the provisionsof Council Directive80/181/EEC
1.具有监测功能的器械进行并且以合法单位表示的测量应符合理事会第
15.2号指令关于成员国对于测量单位的相似法律以及废除第号指80/181/EEC71/354/EEC令的规定11CouncilDirective80/181/EEC of20December1979on theapproximation of the lawsof the Member Statesrelating tounits ofmeasurement and on therepeal ofDirective71/354/EEC OJL39,
15.
2.1980,p.
40.年月日关于成员国关于衡量单位法律的理事会第号指令,并废除第号指令11979122080/181/EEC71/354/EEC0JL39,
15.
2.1980,p.
4016.Protection againstradiation辐射防护
16.
16.
1.General概述
16.1a Devices shall be designed,manufactured andpackaged in sucha way thatexposureofpatients,users andother personsto radiationis reduced as faras possible,andina mannerthat iscompatible withthe intended purpose,whilst notrestricting theapplicationofappropriatespecified levelsfor therapeuticanddiagnostic purposes.必须适当地设计、生产和包装器械,确保在预定用途下尽量减少对患者、便用者a和其他人员造成辐射,但在治疗和诊断目的使用下不对规定合理的剂量进行限制b Theoperating instructions for devicesemittinghazardous orpotentiallyhazardousradiation shall contain detailed information as to the nature of the emittedradiation,the means of protectingthe patientand the user,andonways ofavoiding misuseandof reducingthe risksinherent to installation as faras possibleand appropriate.Information regarding the acceptanceand performancetesting,the acceptancecriteria,and themaintenance procedureshall alsobe specified.发出有害或潜在危险辐射的器械的操作说明应包含关于发射辐射性质、保扩患者b和使用者的方法,以及避免误用和尽可能和适当减少安装固有风险的详细信息此外,还应指定有关验收试验、性能试验、验收标准以及维修保养程序的佶息
16.
2.Intended radiation预期辐射
16.3a Wheredevices aredesigned toemit hazardous,or potentiallyhazardous,levels ofionizingand/or nonionizing radiation necessary for a specific medical purpose thebenefitofwhichis consideredto outweighthe risksinherent to the emission,it shallbepossible for the user to controlthe emissions.Such devices shallbe designed andmanufacturedto ensurereproducibility ofrelevant variableparameters within anacceptable tolerance.若器械因实现特定医疗目的而不可避免地辐射危害或潜在危害水平的电离和/或a非电离辐射,并且其受益一般视为超过该辐射内固有的风险,则使用者必须可控制辐射此类器械的设计和生产应确保相关可变参数在可接受公差范围内的再现性b Wheredevices areintended toemit hazardous,or potentiallyhazardous,ionizingand/or non-ionizingradiation,they shallbe fitted,where possible,with visualdisplaysand/or audiblewarnings ofsuch emissions.当器械用于发射有害或潜在危险的电感和/或非电离辐射时,应尽可能安装此类发b射的可视显示器和/或声响报警信号
16.
3.Devices shallbe designedand manufacturedin sucha waythat exposureofpatients,users andother personsto theemission ofunintended,stray orscatteredradiation isreducedas faras possible.Where possibleand appropriate,methods shallbeselected whichreduce theexposure toradiation ofpatients,users andotherpersons whomay beaffected.应采用适当方式设计和生产器械,确保尽可能降低患者、使用者和其他人员遭
16.3受非预期、漫辐射或散射辐射暴露在可能和适当的情况下,应选择减少患者、使用者和可能受影响的其他人的辐射暴露方法
16.
4.Ionising radiation电离辐射
16.
4.a Devices intended toemit ionizingradiation shallbe designedand manufacturedtaking into accounttherequirementsof theDirective2013/59/Euratom layingdownbasic safetystandards forprotection againstthe dangersarising fromexposure toionising radiation.旨在发射电离辐射的器械的设计和生产应考虑到第号指令的要求,2013/59/Euratom其中规定了防止由于暴露于电离辐射而产生危险的基本安全标准b Devicesintendedtoemit ionisingradiation shallbe designedand manufacturedinsuch a wayas toensure that,where possible,taking into accountthe intendeduse,thequantity,geometry andquality of the radiationemitted can be variedandcontrolled,and,if possible,monitored duringtreatment.旨在发射电离辐射的器械的设计和生产应确保如可能考虑到可在治疗期间改变和控制和(如可能)监测所发射辐射的预期用途、数量、几何形状和质量()b Devicesemitting ionisingradiation intended for diagnosticradiology shallbedesigned and manufacturedin sucha wayas to achievean imageand/or outputqualitythat areappropriate to the intendedmedicalpurposewhilst minimisingradiationexposure of the patientand user.若会发射离子辐射的器械预定用于放射医学诊断,则应采用适当方式设计和生产器械,确保获得符合预期医疗用途的合适图像和/或输出质量,同时尽量减少对患者和使用者的辐射()d Devices that emitionisingradiation and areintended for therapeutic radiologyshallbe designedand manufacturedin sucha wayas toenable reliablemonitoring andcontrolof thedelivered dose,the beamtype,energy and,where appropriate,thequality ofradiation.若会发射离子并预定用于放射医治的器械,则应采用适当方式设计和生产器械,确保可1监
7.控El和ect控ro制ni器cp械ro辐gr射am剂m量ab、le光sy束st类em型s和—能d量ev以ice及s辐th射at质inc量or(po如ra适te用e)lectronicprogrammable systemsand softwarethat aredevices inthemselves
17.可编程电子系统——包含可编程电子系统的器械与本身就是器械的软件.
17.
1.Devicesthat incorporate electronicprogrammable systems,including software,or softwarethat aredevices inthemselves,shallbe designedtoensure repeatability,reliability and performance inlinewiththeir intendeduse.ln the event ofa singlefaultcondition,appropriate meansshallbeadopted toeliminateor reduceasfar aspossibleconsequentrisks orimpairment ofperformance.包含可编程电子系统(包括软件)的器械或者自身为器械的软件,其设计应根
17.1据其预期用途确保相应可重复性、可靠性和性能在单一故障条件下,应采取适当手段以尽可能消除或降低由此造成的风险或性能损害For devices thatincorporatesoftware orfor softwarethataredevices inthemselves,the softwareshallbedeveloped and manufacturedin accordance withthe state of the arttaking into accounttheprinciples ofdevelopment lifecycle,riskmanagement,including informationsecurity,verification andvalidation.针对包含软件的器械或自身为器械的软件,应根据现有技术开发和生产软件,
17.2同时考虑开发生命周期原则、风险管理,包括信息安全、验证和确认
17.
3.Software referredto inthis Sectionthat is intendedto beusedin combinationwithmobile computingplatforms shallbe designedand manufacturedtaking intoaccountthe specificfeatures of the mobileplatform e.g.sizeandcontrast ratioof thescreenand theexternal factorsrelated to their usevarying environmentas regardslevelof lightor noise.本节所指软件用于与移动计算平台结合使用,其设计和制作应考虑移动平台的
17.3具体特征如,屏幕的大小和对比度以及与其用途相关的外部因素环境变化,如光照或噪声水平
17.
4.Manufacturers shallset outminimum requirementsconcerning hardware,ITnetworks characteristics and IT security measures,including protectionagainstunauthorised access,necessary torun thesoftware as intended.NA制造商应规定有关硬件、网络特性和安全措施的最低要求,包括防止非授
17.4IT IT权访问、按预期运行软件的必要条件有源医疗器械
18.Active devicesand devicesconnected to them
18.
1.For non-implantable activedevices,inthe event ofa single对于非植入式有源器械,在出现单一故障情况时,应采取适当的措施尽可能消NA
18.1除或减少由此产生的风险
18.
2.Devices wherethe safety of the patient dependson aninternal power supplyshall beequipped witha meansof determiningthestate of the powersupplyand anNAappropriatewarning or indication forwhen thecapacity of thepower supplybecomes critical.If necessary,such warningorindicationshallbegivenprior to thepowersupply becomingcritical.当患者的安全性取决于内部电源时,此类器械应配备可确定电源状态的手段,
18.2并且当电源容量处于临界值时必要时应在电源容量变为临界值之前,提供适当警告或指示
18.
3.Devices wherethesafetyof the patient dependsonanexternal powersupplyshall include an alarmsystem tosignal anypower failure.NA若患者安全取决于外部供电,器械必须包含一个报警系统,用于指示任何电力
18.3故障
18.
4.Devicesintendedto monitor one ormore clinicalparameters ofa patientshallbe equippedwith appropriatealarm systemsto alertthe userof situationswhich couldleadto deathor severedeterioration of the patientsstateofhealth.NA若器械预定用于监测患者内一个或多个临床参数,器械必须配备适当报警系统,
18.4用于提供有关可导致患者死亡或健康状态严重恶化的警戒信息给使用者
18.
5.Devices shallbe designedand manufacturedin sucha wayas toreduceas faras possiblethe risksof creatingelectromagnetic interferencewhich couldimpair theoperationof the device inquestion or otherdevicesor equipmentinthe intendedNAenvironment.器械的设计和生产应尽可能降低产生电磁干扰的风险,以免影响相关器械或该
18.5使用环境下其他器械或设备的操作
18.
6.Devices shallbe designedand manufacturedin sucha wayas toprovide alevelof intrinsicimmunity toelectromagnetic interferencesuch that is adequateto enablethemto operateas intended.NA器械的设计和生产应提供充足的抗电磁干扰天然免疫水平,使其足以使器械按
18.6预期操作
18.
7.Devices shallbe designedand manufacturedin sucha wayas toavoid,asfarasNApossible,therisk of accidentalelectric shockstothe patient,user or anyother person,both duringnormaluse of the device andintheevent ofa singlefaultcondition inthe device,provided the device isinstalled andmaintained as indicated bythe manufacturer.器械的设计和生产应尽可能避免在正常使用器械期间和在单一故障情况下对患者、使用者或任何其他人造成意外电击危险,但前提是器械须按照制造商的指示安装和维护保养
18.
8.Devices shallbe designedand manufacturedin sucha wayas toprotect,asfaras possible,against unauthorizedaccess that could hamperthe devicefromfunctioning asintended.NA器械的设计和生产应尽可能保护对器械的未经授权访问,以免器械无法正常运
18.8行有源可植入器械的特殊要
19.Particular requirementsfor active implantable devices求
19.
1.Active implantabledevices shallbe designedand manufacturedin such away as toremoveor minimizeasfaraspossible:a risksconnected withtheuseof energysources withparticular reference,whereelectricity isused,to insulation,leakage currentsand overheatingof the devices,b risksconnected withmedical treatment,in particularthose resulting from theuseof defibrillatorsor highfrequencysurgical equipment,andc riskswhich mayarise wheremaintenance andcalibrationareimpossible,NAincluding:—excessive increaseof leakagecurrents,一ageingof the materialsused,—excess heatgenerated by the device,一decreased accuracyof anymeasuringorcontrol mechanism.应采用适当方式设计和生产有源可植入器械,确保尽可能地避免或减少根据特定参考文献,与使用能源相关的风险,如使用电力,器械的绝缘、漏泄a电流和过热风险,与医疗有关的风险,特别是使用除颤器或高频外科手术器械产生的风险,b在不可能进行维护和校准时可能出现的风险,包括c-漏泄电流过度增大;-所使用材料的老化;-器械产生的过热测量或控制机制准确性降低
19.
2.Active implantabledevices shallbedesignedand manufacturedin sucha wayasto ensure—if applicable,the compatibilityof the deviceswiththe substancesthey areintendedto administer,andNA—the reliabilityof thesource of energy.有嫄可植入器械的设计和生产应确保-如适当,器械与其预期施用物质的兼容性,-能源的可靠性
19.
3.Active implantabledevicesand,if appropriate,their component parts shallbeidentifiable toallow any necessary measureto be taken followingthe discoveryof aNApotentialrisk inconnectionwiththe devicesor theircomponentparts.有源可植入器械(如适当)及其组成部分应可识别,以便允许在发现与器械或其组成部分相关的潜在风险之后采取任何必要的措施
19.
4.Active implantabledevicesshall bear a code bywhich theyand their(manufacturer canbe unequivocallyidentified particularlywithregardtothetype of)device and its year of manufacture;it shallbe possibleto readthis code,if NAnecessary,without theneed fora surgicaloperation.有源可植入器械应附带可明确识别自身及其制造商的代码(特别是关于器械的类型和生产年份);若必要,应可读取该代码,而不需要进行外科手术机械和热风险防护
20.Protection against mechanical and thermal risks
20.
1.Devices shallbedesignedand manufacturedin sucha wayas toprotectpatientsand usersagainstmechanicalrisksconnectedwith,for example,resistance tomovement,instability andmoving parts.应采用适当方式设计和生产器械,确保防止患者和使用者遭受与机械特征有关
20.1的机械风险,例如运动阻力、稳定性或运动部件等
20.
2.Devices shallbedesignedand manufacturedin sucha wayastoreduce tothelowest possiblelevel the risks arising from vibrationgenerated by the devices,takingaccount oftechnical progressand of the means available forlimiting vibrations,particularly atsource,unless thevibrations arepart of the specifiedperformance.应采用适当方式设计和生产器械,确保尽量降低因器械振动引起的风险水平,
20.2并考虑利用先进技术和手段限制振动(尤其振动源处),除非振动是规定性能中一部分
20.
3.Devices shallbedesignedand manufacturedin suchawayastoreduce tothelowest possiblelevel the risks arisingfrom thenoise emitted,taking accountoftechnical progressand of the meansavailable toreduce noise,particularly atsource,unless thenoise emittedis part of thespecifiedperformance.应采用适当方式设计和生产器械,确保尽量降低因噪音释放而产生的风险水平,
20.3并考虑利用先进技术和手段减少噪音(尤其噪音源处),除非这种噪音是规定性能中组成部分
20.
4.Terminals andconnectors tothe electricity,gas orhydraulic andpneumaticenergy supplieswhichthe user orother personhas tohandle,shallbedesigned andconstructed insuchawayastominimise allpossible risks.若使用者或他人必须操作连接到电力、气体、液压或气动能量供给源的端子
20.4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.Risk controlmeasures adoptedby manufacturersfor the design andmanufacture ofthe devicesshallconform tosafety principles,taking accountof the generallyacknowledged stateof theart.To reducerisks,Manufacturers shallmanage risksso thattheresidual riskassociatedwitheach hazardas wellas the overall residualrisk isjudgedacceptable.Tn selectingthe mostappropriate solutions,manufacturers shall,in thefollowingorder ofpriority:
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 eliminateorreducerisksasfaraspossible throughsafe designandmanufacture;通过安全的设计和生产尽可能消除或降低风险;b where appropriate,take adequateprotection measures,including alarmsifnecessary,inrelationtorisks thatcannotbeeliminated;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 provideinformation forsafety warnings/precautions/contra-indicationsand,where appropriate,training to users.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Manufacturers shallinform usersof anyresidual risks.制造商应将剩余风险告知使用者
5.In eliminatingor reducingrisks related to useerror,the manufacturer shall:
6.在消除或减少使用不当相关风险时,制造商应a reduceasfaraspossibletherisks related tothe ergonomicfeatures和连接器,应采用适当方式设计和构造此类端子和连接器,确保尽量降低任何潜在风险
20.
5.Errors likelyto be made whenfitting orrefitting certainparts whichcould beasource ofrisk shallbe madeimpossible by thedesignand constructionofsuchparts or,failing this,by informationgiven on the partsthemselves and/or theirhousings.The sameinformation shallbegivenon movingparts and/or theirhousings wherethedirection ofmovement needsto beknown in order toavoid arisk.当安装或重装某些部件时可能出现的失误将有可.能成为风险的源头,此类部件
20.5的设计和构造应完全避免该风险,若无法实现,则应通过在部件和/或其外壳的信息说明当需要知道移动方向以避免风险,相同信息应在活动部件和/或其外壳说明
20.
520.
6.Accessible parts of devicesexcluding theparts orareas intendedto supplyheator reachgiven temperaturesand theirsurroundings shallnot attainpotentiallydangerous temperaturesunder normalconditions ofuse.在正常使用条件下,器械内可接触部件不包括拟供热或达到给定温度的部件或
20.6区域及其周围可触及部件不会达到造成危险的温度
21.Protection againsttherisksposed tothe patientor userbydevicessupplyingenergy or substances通过器械供应能量或物质防止对患者或使用者造成危险
21.
21.
1.Devices forsupplying the patient withenergy or substances shallbe designedandconstructedinsuchawaythatthe amountto bedelivered canbe setandmaintained accuratelyenough toensure thesafetyof the patientand of the user.若器械预定用于为患者供给能量或物质,应采用适当方式设计和生产器械,确
21.1保能够准确地设置和维持输送量,从而足以保证患者和使用者的安全
21.
2.Devices shallbe fittedwiththe meansofpreventing and/or indicating anyinadequacies inthe amountof energydelivered or substances deliveredwhich couldpose a danger.Devices shallincorporate suitablemeans toprevent,asfaraspossible,the accidentalrelease ofdangerous levelsofenergyorsubstancesfrom anenergyand/orsubstancesource.器械应配备防止和/或指示输送可能产生危险的能量或物质数量方面的任何不
21.2足器械必须集成适当手段,确保尽可能地防止危险等级的能源或物质从能源及/或物质来源中泄漏
21.
3.The functionof thecontrols andindicators shallbe clearlyspecified onthedevices.Where a device bearsinstructions required for itsoperation orindicatesoperating oradjustment parametersbymeansofavisual system,such informationshallbe understandabletothe user and,as appropriate,thepatient.控制器和指示器功能必须明确地注明在器械上若器械提供使用说明或者通过
21.3一个可视系统指示操作或调整参数,必须保证使用者和患者(如适用)易于理解这些信息
22.Protection againsttherisksposed bymedical devices intended by themanufacturer for use bylay persons防止制造商预期用于非专业人员使用的医疗器械所造成的危险
22.
22.
1.Devices for use bylay personsshallbedesignedandmanufacturedinsuch awaythat theyperform appropriatelyfor theirintended purposetakingintoaccount theskillsand themeansavailableto lay persons and the influenceresultingfromvariationthat canbe reasonablyanticipated inthe lay persons techniqueand environment.Theinformation andinstructions providedby the manufacturershallbe easyfor the layperson tounderstand andapply.由非专业人员使用的器械的设计和生产应使其适用于预期用途,其中考虑到可
22.1用于专业人员的技能和方法以及在非专业人员的技术和环境中合理预期差异导致的影响制造商提供的信息和说明应易于非专业人员理解和应用
22.
2.Devices for use bylay personsshallbedesignedandmanufacturedinsuchawayasto:一ensure thatthe device canbeused safelyand accuratelybythe intended useratall stagesoftheprocedure,if necessaryafter appropriatetraining and/or information,一reduce,asfaraspossibleandappropriate,theriskfrom unintendedcuts andprickssuch asneedle stickinjuries,andreduce asfaraspossibletheriskoferror bythe intendeduser inthe handlingofthe device and,if applicable,intheinterpretation ofthe results.由非专业人员使用的器械的设计和生产应
22.2-确保目标使用者在适当训练和/或信息获得后的所有必要治疗阶段均可安全且准确使用器械;和-尽可能减少并消除意外由于切割和刺破造成的风险,例如针刺损伤;和-尽可能减少预期使用者在处理器械以及(如适当)在结果解读中的错误风险
22.
3.Devices for use bylaypersonsshall,where appropriate,includeaprocedure bywhichthelayperson:一can verifythat,atthe time ofuse,the devicewill performasintendedby themanufacturer,and——if applicable,is warned if the device hasfailed toprovide avalid result.由非专业人员使用的器械(如适当)应包括非专业人员使用的规程
22.4-在使用时,可验证器械将按照制造商的意图工作,并且-如适当,若器械未能提供有效的结果,则发出警告第章有关器械随附信息的要求CHAPTER IIIREQUIREMENTS REGARDINGTHE INFORMATIONSUPPLIED WITHTHE DEVICEni
23.Label andinstructions for use标签和使用说明书
23.
23.
1.General requirementsregardingthe information supplied bythe manufacturer制造商需提供的信息的一般要求
23.1Each device shallbeaccompanied bythe information needed to identify the deviceand itsmanufacturer,and byany safetyand performanceinformation relevantto theuser,orany otherperson,as appropriate.Such informationmay appear onthe deviceitself,onthe packaging orinthe instructions for use,andshall,if the manufacturer hasawebsite,bemade available andkept upto dateonthewebsite,takingintoaccountthe following:各器械应附有识别潜械及其制造商所需的信息,并酌情将安全与性能信息传达给使用者或其他人此类信息可能出现在器械本身、包装上或使用说明书中,若制造商有网站,则应在网站上提供并保持更新最新信息,同时考虑到以下因素a Themedium,format,content,legibility,and locationofthelabel andinstructions foruse shallbeappropriate tothe particulardevice,its intendedpurpose and the technical knowledge,experience.education ortraining oftheintended users.In particular,instructions foruse shallbewritten interms readilyunderstood bytheintendeduser and,whereappropriate,supplemented withdrawings anddiagrams.标签和使用说明的介质、格式、内容、易读性和位置应适合于特定器械、其预期目的和对预期使用者的技术知识、经验、教育或培训尤其是,使用说明书应以预期使用者容易理解的语言撰写,并且在适当时,补充图纸和图表b The information requiredonthelabel shallbe providedonthe deviceitself.If thisis not practicableor appropriate,some orall oftheinformationmay appearon thepackagingfor eachunit,and/oronthepackagingof multiple devices.标签上所需的信息应在器械本身上提供若不可行或不适当,则某些或所有信息可显示在各单元的包装上和/或多个器械的包装上在向单个使用者和/或位置提供多个器械的情况下,若购买者如此同意,则可提供使用说明的单个副本,在任何情况下购买者可请求免费提供进一步的副本c Labelsshallbe provided ina human-readable formatand may be supplementedbymachine-readable information,such asradio-frequency identificationRFID orbarcodes.标签应以人类可读的格式提供,并可通过机器可读信息,例如射频识别或“RFID”条形码来补充d Instructionsforuseshallbe provided together with devices.By wayof exception,instructions foruseshallnot berequiredforclass1and classIla devicesif such devicescan beused safely without anysuch instructions and unlessotherwise providedforelsewhere inthis Section.使用说明应与器械一起提供例外情形对于类和类器械,若在无使用说明书I Ha的情形下同样可安全地使用器械,则无需此类使用说明书除非本节其他地方另有规定e Wheremultipledevicesare supplied toa single user and/or location,asinglecopyof theinstructions foruse maybe providedif soagreed bythe purchaserwho inanycase mayrequest furthercopies to beprovidedfree ofcharge.当向单个使用者和/或位置提供多个器械时,若购买者同意,则可提供使用说明的单个副本,但购买者在任何情况下可请求免费提供其他副本f Instructionsforusemaybeprovided tothe userin non-paper formate.g.electronic tothe extent,and onlyunder theconditions,set out inRegulationEUNo207/2012orinany subsequentimplementing rulesadopted pursuant to thisRegulation.若根据第号法规或根据本法规通过的任何后续实施规则中规定的条件,207/2012可向使用者提供非纸质格式例如,电子格式使用说明g Residualriskswhichare required to becommunicated tothe user and/or otherpersonshallbeincluded aslimitations,contra-indications,precautions orwarnings intheinformation suppliedbythe manufacturer.需要传达给使用者和/或其他人的剩余风险应包括作为制造商所提供信息中的限制、禁忌症、预防措施或警戒h Whereappropriate,theinformationsuppliedbythemanufacturershall taketheform ofinternationally recognisedsymbols.Any symbolor identificationcolourused shallconform tothe harmonisedstandards or CS.In areasfor whichnoharmonised standardsorCSexist,the symbolsand coloursshall bedescribedin thedocumentationsupplied withthe device.如适当,制造商提供的信息应采用国际公认的符号形式使用的任何符号或识别颜色应符合协调标准或若未协调标准或符号和颜色应说明在随同器械提供的文件CS CS,中标签上的信息
23.
2.Information onthelabel标签必须注明下面全部事项The labelshallbearall ofthe followingparticulars:a thename ortrade nameofthe device;器械的名称或商品名称;b thedetails strictlynecessaryfora usertoidentifythe device,the contentsof thepackagingand,where it is notobvious forthe user,theintendedpurpose ofthe device;使用者识别器械所必需的详细信息、包装内容以及对于使用者不明显的器械预期用途;c thename,registered tradename orregistered trademark ofthe manufacturerand the address of itsregistered place of business;制造商的名称、注册商号或注册商标及其注册营业地点的地址;dif themanufacturerhas itsregistered placeof businessoutside the Union,thename ofthe authorised representative andaddress ofthe registeredplaceofbusinessof theauthorisedrepresentative;授权代表的姓名和授权代表的注册营业地点地址若制造商在欧盟以外有其注册营业地点;e where applicable,an indication thatthe device containsor incorporates:——amedicinalsubstance,including ahuman bloodor plasmaderivative,or——tissues orcells,or theirderivatives,ofhuman origin,or—tissues orcells ofanimalorigin,or theirderivatives,as referredtoinRegulationEU No722/2012;如适当,器械包含或采用的指示信息,-药物,包括人血或血浆衍生物或-人源的组织或细胞或其衍生物或-动物源的组织或细胞或其衍生物,如第号法规所述722/2012如适当,f where applicable,information labelledin accordancewith Section
10.
4.5,;标签信息应符合第节规定;gthe lot number orthe serial number ofthe device precededbythe words LOTNUMBER or SERIALNUMBERoran equivalentsymbol,as appropriate;器械的批号或序列号前面带有批号或序列号的词语或等同的符号若适用;根据第i theUDI carrierreferredtoin Article274and PartC of Annex VII;274条和附录第部分的;VII CUDIi anunambiguous indication oftthetime limit for using or implanting the devicesafely,expressed atleast interms ofyear andmonth,where thisis relevant;明确表示可安全使用或植入器械的时间限制,至少表示为与之相关的年份和月份;jwhere there isnoindication ofthe dateuntil whenit maybeusedsafely,the dateof manufacture.This date ofmanufacturemaybeincluded aspartofthe lotnumber orserialnumber,provided thedate isclearly identifiable;若没有表示可安全使用的日期,则标识生产日期若日期清晰可辨,生产日期可作为批号或序列号的一部分;指明适kan indicationof anyspecial storage and/or handlingcondition thatapplies;用的任何特殊储存和/或处理条件;1if the device is supplied sterile,an indicationof itssterile stateandthesterilisationmethod;若以无菌方式提供的器械,还应标识其无菌状态和灭菌方法;m warningsor precautionsto be taken thatneed to be broughttotheimmediateattention ofthe userofthe device,and toanyotherperson.This informationmay bekepttoaminimum inwhich casemore detailedinformation shallappear inthe需要立即引起器械使用者instructions foruse,takingintoaccounttheintendedusers;和任何其他人的注意、需要采取的警戒或预防措施该信息可保持最小量,在这种情况下,更详细的信息将出现在使用说明中,同时考虑到预期使用者;n if the device is intendedfor single use,an indicationof thatfact.A manufacturers若器械用于一次性使用,indicationofsingleuseshallbeconsistent acrosstheUnion;则相应表示制造商的一次性使用指示应在整个欧盟内保持一致;o if the device is asingle-use devicethat has been reprocessed,an indicationof thatfact,the numberof reprocessingcycles alreadyperformed,and anylimitation asregards the numberof reprocessingcycles;若器械是己进行再处理的一次性使用器械,提供该事实的指示信息、己执行的再处理循环次数以及关于再处理循环次数的任何限制;若器械是定制的,p ifthe device is custom-made,the wordscustom-made device;则提供词语“定制器械”;q anindication thatthe device is amedical device.If the deviceis intended forclinical investigation only,the wordsexclusively for clinicalinvestigation;一项表示信息,用于标识器械为医疗器械若本器械仅预定用于临床研究,应标明“临床研究专用”;rinthe caseofdevicesthatarecomposed ofsubstancesorofcombinations ofsubstances thatareintendedto beintroduced into the humanbody viaa bodyorificeor appliedtotheskin and thatareabsorbedbyorlocallydispersed inthe humanbody,the overallqualitative compositionofthedeviceandquantitative information on themainconstituent orconstituents responsiblefor achievingthe principalintendedaction;若器械包含预计经由身体孔口引入人体或施加在皮肤上,并被人体吸收或局部喷洒在人体上的物质或物质组合,则提供器械的整体定量成分和负责实现主要预期作用的主要成分的定量信息;sforactiveimplantabledevices,the serialnumber,and forother implantable匚对于有源可植入器械,提供序列号,对devices,theserialnumberorthelotnumbe于其他可植入器械,提供序列号或批号
23.
3.Information onthepackagingwhich maintainsthe sterilecondition ofadevicesterile packaging关于保持器械无菌条件的包装信息“无菌包装”
23.3The followingparticulars shallappearonthe sterile packaging:无菌包装上应出现以下细节指明无菌aanindication permittingthe sterilepackaging to be recognisedas such,包装标识;声明该器械处于无菌状态;b adeclaration thatthedeviceisinasterilecondition,灭菌方法;c themethod ofsterilisation,制造商名称和地址;dthename andaddressofthemanufacturer,器械说明;eadescription ofthedevice,f ifthedeviceisintendedforclinicalinvestigations,the wordsexclusively forclinicalinvestigations,若本器械仅预定用于临床研究,应标明“临床研究专用”若属于定制器械,g ifthedeviceis custom-made,thewordscustom-made device,应标明“定制器械”;生产年月;hthemonth andyearofmanufacture,i anunambiguous indicationofthetimelimitforusingorimplantingthe devicesafelyexpressed atleast interms ofyear andmonth,and安全使用或植入器械的时间限制的明确指示信息,并表示为与之相关的年月;j aninstruction tocheck theinstructions foruse forwhat todo ifthe sterilepackagingis damagedor unintentionallyopened beforeus检查使用说明的说明,即若无菌包装损坏或在使用前不小心打开,该如何处理ofthedeviceandthe environmentinwhichthedeviceisintendedto beused(designfor patientsafety),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)give considerationtothetechnicalknowledge,experience,education,trainingand useenvironment,whereapplicable,andthemedical andphysical conditions ofintended users(design forlay,professional,disabled orother users).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.The characteristicsandperformance ofadeviceshallnot beadversely affectedtosucha degreethat thehealthorsafety ofthepatientor the userand,whereapplicable,ofother personsare compromisedduring thelifetime ofthedevice,asindicatedby themanufacturer,whenthedeviceissubjectedtothe stresseswhich canoccur duringnormalconditionsofuseandhas beenproperly maintainedin accordancewith themanufacturersinstructions.
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.Devicesshal1bedesigned,manufactured andpackagedinsuchawaythattheircharacteristics andperformance duringtheirintendeduse arenot adverselyaffectedduring transportandstorage,for example,through fluctuationsof temperatureandhumidity,taking accountoftheinstructionsandinformation providedbythemanufacturer.
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
23.
4.Information intheinstructionsforuse使用说明书中的信息
23.
4.The instructionsforuseshallcontainall ofthefollowingparticulars:使用说明应包含以下全部详细规定a theparticulars referredtoinpointsa,c,e,f,k,1,nandrofSection
23.2;第条、、、、和点所述的详细规定;
23.2acefk1n rbthe devicesintendedpurposewithaclear specificationof indications,contra-indications,thepatienttarget groupor groups,and oftheintendedusers,asappropriate;器械的预期用途具有适应症、禁忌症、患者目标群体和预期使用者如适用的明确规范;c whereapplicable,a specificationoftheclinical benefits to beexpected.如适用,提供预期的临床受益规范;dwhereapplicable,links tothe summaryof safetyand clinicalperformance referredtoin Article32;如适用,提供按照第条的安全和临床性能总结链接;32etheperformance characteristicsofthedevice;器械的性能特征;f whereapplicable,information allowingthe healthcareprofessional to verify ifthedevice issuitable andselect thecorresponding softwareand accessories;如适用,提供信息用于医疗保健专业人员验证器械是否合适,并选择相应的软件和附录;ganyresidual risks,contra-indications and any undesirable side-effects,includinginformation to be conveyedtothepatient inthis regard;任何剩余风险、禁忌症和任何不良副作用,包括传达给患者的关于这方面的信h specificationstheuserrequires touse thedevice appropriately,e.g.ifthedevicehas ameasuringfunction,the degreeofaccuracyclaimed forit;规范使用者适当地使用器械的要求,例如,若器械具有测定功能,提供其所要求的准确度;i details ofany preparatory treatment or handlingofthedevice beforeit isready foruse or during its use,such assterilisation,final assembly,calibration,etc.,including thelevelsof disinfectionrequiredtoensure patientsafetyandall availablemethods forachievingthose levelsof disinfection;在准备使用之前或在其使用例如,灭菌、最终组装、校准等期间器械的任何预处理或处理的细节,包括确保患者安全所需的消毒水平和实现那些消毒水平所需的所有可用方法;所有特殊设备的任何要求或特殊培训或器械使用者和/或其他人的特定资格;k theinformationneededtoverifywhether thedeviceisproperly installedand isready toperform safelyand asintendedbythemanufacturer,togetherwith,where relevant:验证器械是否正确安装并是否准备好安全以及按制造商意图执行的信息(若相关):一detailsofthenature,and frequency,of preventiveand regularmaintenance,and ofanypreparatorycleaning ordisinfection,—预防和定期维护以及任何预备清洁或消毒的性质和频率的详细信息;——identification ofany consumablecomponents andhow toreplace them,—任何消耗部件的标识和更换方法;—information onanynecessarycalibration toensurethatthedeviceoperates properlyand safelyduringitsintended lifetime,and—任何必要的校准信息,其用以确保器械在其预期寿命期间正常和安全地工作;—methods foreliminating therisks encounteredby personsinvolved ininstalling,calibrating orservicing devices;一消除参与安装、校准或维修器械的人所遇到风险的方法l ifthedeviceis suppliedsterile,instructions intheeventofthesterilepackagingbeing damagedor unintentionallyopened before use;若提供的器械是无菌的,则无菌包装在使用前被损坏或无意打开的情况下,应提供说明m ifthedeviceissuppliednon-sterile withthe intentionthat it is sterilisedbeforeuse,the appropriateinstructionsforsterilisation;若提供的器械是非无菌的,并且需要在使用前进行灭菌,应提供适当的灭菌说明n ifthedeviceis reusable,information onthe appropriateprocesses forallowingreuse,including cleaning.disinfection,packaging and,where appropriate,thevalidated methodofre-sterilisation appropriatetotheMember Stateor MemberStatesin whichthedevicehasbeenplacedonthemarket.Information shallbeprovidedtoidentify whenthedeviceshould nolonger be reused,e.g.signs ofmaterial degradationorthe maximumnumberofallowable reuses;若器械可重复使用,提供重复必需的适当处理过程的相关信息,包括清洁、消毒、包装以及如适当经过验证的适用于器械投放市场所在成员国的重新灭菌方法应提供信息以识别该器械何时不得再使用,例如,材料老化迹象或允许重复使用的最大数量nanindication,if appropriate,thatadevicecanbereusedonly ifitisreconditionedunder theresponsibility ofthemanufacturerto complywiththe general safetyandperformance requirements;必要的指示信息,指示只有在制造商负责进行重新调整后符合基本安全和性能要求,方可重复使用该器械o ifthedevicebears anindicationthatitisfor singleuse,information onknowncharacteristics andtechnical factorsknown tothemanufacturerthatcouldposeariskif thedevice wereto bere-used.This informationshallbebasedonaspecificsectionof themanufacturers riskmanagement documentation,where suchcharacteristics andtechnicalfactors shallbeaddressedin detail.If in accordancewithpoint dofSection
23.
1.no instructionsforuseare required,this informationshallbemade availabletothe user upon request;若器械带有一次性使用标识,在重复使用器械的情形下,制造商已知的特性和技术因素相关信息可能会构成风险此信息应基于制造商风险管理文档的特定部分,应详细说明这些特征和技术因素若按照第节点无需任何使用说明,该信息必须按
23.1d要求提供给使用者q fordevicesintendedforusetogetherwithotherdevicesand/or generalpurposeequipment:—information toidentify suchdevicesorequipment,inorder to obtaina safecombination,and/or——information onany knownrestrictions tocombinationsofdevices andequipment;对于旨在与其他器械和/或通用设备一起使用的器械—信息用于识别这些器械或设备,以便获得安全组合,和/或一有关器械和设备组合的任何已知限制的信息rif thedevice emitsradiation formedical purposes:一detailedinformationastothenature,type andwhere appropriate,the intensityanddistribution ofthe emittedradiation,一themeansof protectingthepatient,user,orotherperson fromunintendedradiation duringuseofthedevice;若器械发出辐射用于医疗用途-关于发出辐射的性质、类型和如适当强度和分布的详细信息;■防止患者、使用者或其他人在使用器械期间受到意外辐射的方法s informationthat allowstheuserand/or patientto beinformed ofany warnings,precautions,contraindications,measures tobetakenand limitationsofuse regardingthe device.That informationshall,where relevant,allow theusertobrief thepatientabout anywarnings,precautions,contra-indications,measures tobetakenandlimitations ofuseregardingthedevice.Theinformationshall cover,whereappropriate:有关允许向使用者和/或患者通知任何警示、预防措施、禁忌症、待采取措施以及与器械有关的使用限制信息在相关情况下,此信息应允许使用者向患者简述所有警示、预防措施、禁忌症、待采取措施以及与器械有关的使用限制该信息应酌情包括—warnings,precautions and/or measurestobetaken intheeventof malfunctionofthedeviceor changesin itsperformance that may affectsafety,一器械发生故障或可能会影响安全的性能变化时的警示、预防措施和/或待采取措施;一warnings,precautions and/or measurestobetaken asregards theexposure toreasonablyforeseeableexternalinfluencesorenvironmentalconditions,suchas magneticfields,external electricaland electromagneticeffects,electrostatic discharge,radiation associatedwith diagnosticor therapeuticprocedures,pressure,humidity,or temperature,-警示、预防措施和/或就暴露于合理可预见的外部影响或环境条件采取的措施(例如磁场、外部电和电磁效应、静电放电、与诊断或治疗过程相关的辐射、压力、湿度、或温度;一warnings,precautions and/or measurestobetaken asregardstherisks ofinterferenceposed bythe reasonablyforeseeable presenceofthedevice duringspecificdiagnostic investigations,evaluations,or therapeutictreatmentorotherprocedures such as electromagneticinterference emittedbythedevice affectingotherequipment,-在特定诊断研究、评价或治疗处理或其他程序(例如,由影响其他设备的器械所发出的电磁干扰)期间,器械的合理可预见存在所造成的干扰风险的警戒、预防措施和/或待采取措施;—ifthedeviceisintendedtoadminister medicinal products,tissues orcells ofhumanor animalorigin,or theirderivatives,or biologicalsubstances,anylimitations orincompatibility inthe choice ofsubstancestobedelivered,-若器械用于管理人或动物源的生物物质药品、组织或细胞或其衍生物,则在选择交付物质时需考虑任何可能的限制或不相容性;——warnings,precautions and/or limitationsrelated tothe medicinalsubstanceor biologicalmaterial thatis incorporated intothedevice asanintegral partofthedevice;and-结合到器械中作为器械组成部分的药物或生物材料相关的警戒、预防措施和/或限制;-—precautions relatedto materialsincorporatedintothedevicethat containorconsist of CMR substancesor endocrine-disrupting substances,or thatcouldresult insensitisation oran allergicreaction bythepatientor user;-与纳入器械的或具有内分泌干扰性质或可能导致患者或使用者的致敏CMR或过敏反应的材料相关的预防措施;tinthe caseofdevicesthatarecomposedofsubstancesorofcombinationsofsubstances thatareintendedtobeintroducedintothe humanbody andthat areabsorbedbyorlocallydispersedinthehumanbody.warnings andprecautions,whereappropriate,relatedtothegeneralprofile ofinteraction ofthedeviceanditsproductsof metabolismwithotherdevices,medicinal productsandothersubstances aswell ascontraindications,undesirable side-effects andrisks relatingto overdose;若拟引入人体并由人体吸收或局部扩散在人体内的物质或物质组合构成,则该器械及其代谢产物产品与其他器械、药品和其他物质间相互作用的一般概况以及禁忌、不良副作用和过量风险的警戒和预防措施如适用u inthecaseof implantabledevices,theoverallqualitative andquantitative对于informationonthe materials and substancesto whichpatients canbe exposed;可植入器械,有关患者可暴露材料和物质的总体定性和定量信息v warningsor precautionstobetaken inordertofacilitatethesafedisposalof thedevice,its accessoriesandtheconsumables usedwith itif any.This informationshalltcover,where appropriate:为便于安全处理潜械、其附录和与其一起使用的耗材如有,应采取的警戒或预防措施该信息应酌情包括—infection ormicrobial hazardssuch asexplants,needles orsurgical equipmentcontaminated withpotentially infectioussubstancesofhumanorigin,and—感染或微生物危害(例如,被人源潜在感染性物质污染的外植体、针或手术器械);一physical hazardssuchasfrom sharps.-物理性危害(例如来自尖锐物)If in accordancewiththepointdofSection
23.1no instructionsforuseare required,this informationshallbemadeavailabletotheuseruponrequest;若可按照第节()点要求无使用说明,则应根据要求将这些信息提供给使用者;
23.1dwfor devicesintendedforuse bylaypersons,the circumstancesinwhichtheusershould consulta healthcareprofessional;对于非专业人员使用的器械,使用者应咨询医护专业人员x forthe devicescoveredbythisRegulationpursuanttoArticle12,information regardingthe absenceofaclinicalbenefitandtherisksrelatedtouseofthedevice;对于根据本法规第()条涵盖的器械,关于缺乏临床受益以及与器械使用相关的12风险信息;y dateof issueoftheinstructionsforuseor,if theyhavebeenrevised,dateofissue andidentifier ofthe latestrevision oftheinstructionsforuse;使用说明书的发布日期,若已修订,最新版本使用说明书的发布日期和标识符z anotice totheuserand/or patientthat anyserious incidentthat hasoccurred in relation tothedeviceshould bereported tothemanufacturerandthecompetent authorityoftheMemberState inwhichtheuserand/orpatientis established;向使用者和/或患者发出关于与器械有关的任何严重事件的通知,应报告给使用者和/或患者所在成员国的制造商和主管机构aa informationtobesuppliedtothepatientwith animplanted devicein accordancewith Article18;根据第条向患者提供有关植入器械的信息18ab fordevicesthatincorporate electronicprogrammable systems,including software,or softwarethataredevicesinthemselves,minimum requirementsconcerninghardware,IT networkscharacteristicsandITsecuritymeasures,including protectionagainst unauthorisedaccess,necessary torun thesoftware asintended.对于结合可编程电子系统的器械,包括软件或器械本身是软件,有关硬件、网络特性和安全措施的最低要求包括防止未经授权的访问对于运行软件来说所必要的ITIT不利影响
8.Al1known and foreseeable risks,andanyundesirableside-effects,shall beminimisedand beacceptable whenweighed againstthe evaluatedbenefitstothe patientand/or userarisingfrom the achievedperformanceofthedeviceduring normalconditionsofuse.
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.For the devices referredtoinAnnex XVI,thegeneralsafety requirementsset outinSections1and8shallbeunderstood tomean thatthedevice,when usedunder theconditionsandforthepurposesintended,does notpresent arisk atall orpresents ariskthat isno morethan themaximum acceptablerisk relatedtotheproducts usewhich isconsistentwithahigh levelof protectionforthesafetyandhealth ofpersons.
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CHAPTER IIREQUIREMENTS REGARDINGDESIGN ANDMANUFACTURE第2章设计和生产相关要求
10.Chemical,physical andbiological properties
10.化学、物理和生物学特性
10.
1.Devices shallbedesignedandmanufacturedinsuchawayastoensurethatthecharacteristics andperformancerequirementsreferredtoin Chapter1are fulfilled.Particular attentionshallbepaidto: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 thechoiceofmaterials and substances used,particularly asregards toxicityand,where relevant.flammability;使用材料和物质的选择,特别是毒性和易燃性如适用bthe compatibility between the materialsandsubstances usedand biologicaltissues,cells andbody fluids,taking accountoftheintendedpurpose ofthedeviceand,所使用材料和物质where relevant,absorption,distribution,metabolism andexcretion;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 thecompatibilitybetweenthe differentpartsofadevicewhich consistsof morethanone implantablepart;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;过程对材料性能的影响;dthe impactof processeson materialproperties;ewhereappropriate,the resultsof biophysicalor modellingresearch thevalidity ofwhich hasbeendemonstrated beforehand;若适用,生物物理学或建模研究结果有效性己事先获得证实;fthemechanical propertiesofthematerialsused,reflecting,whereappropriate,matters suchas strength.ductility,fracture resistance,wear resistanceand fatigueresistance;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;表面活性;g surfaceproperties;andh theconfirmation thatthedevicemeets anydefined chemicaland/or physical
10.
2.Devices shallbedesigned,manufacturedandpackagedinsuchawayastominimise therisk posedby contaminantsand residuestopatients,taking accountofthe intendedpurposeofthedevice,and tothe personsinvolved inthetransport,storageanduseofthedevices.Particular attentionshallbepaid totissuesexposed tothose contaminantsand residuesand tothe durationandfrequency ofexposure.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.Devices shallbedesignedandmanufacturedinsuchawaythat theycan beusedsafelywiththematerialsandsubstances,including gases,with whichthey enterintocontact duringtheirintendeduse;ifthedevicesareintendedtoadministermedicinal productsthey shallbedesignedandmanufacturedinsuchawayastobecompatible withthe medicinal products concernedinaccordancewiththeprovisionsand restrictionsgoverning thosemedicinalproductsandthattheperformanceof boththemedicinalproductsand ofthedevicesis maintainedinaccordancewith theirrespectiveindications andintendeduse.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,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物质
10.
4.Substances器械的设计和生产.Design andmanufacture ofdevicessubstances orparticles,including weardebris,degradation productsand processingresidues,thatmaybe releasedfromthedevice.器械的设计和生产应尽可能降低由物质或微粒(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,or thoseparts thereofor thosematerialsusedtherein that:器械或其部件或其使用的材料—are invasiveand comeinto directcontactwiththehumanbody,一readminister medicines,body liquidsorothersubstances,including gases,to/fromthebody,or—transport orstore suchmedicines,body fluidsorsubstances,including gases,tobe readministeredtothebody,shall onlycontain thefollowing substancesin aconcentrationthatisabove0,1%weight byweight w/w wherejustified pursuanttoSection
10.
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,在根据第节进行调整时,应仅包含浓度高于重量比的以下物质
0.1%asubstances whichare carcinogenic,mutagenic ortoxic toreproduction CMR,of category1A orIB,inaccordancewith Part3ofAnnexVI toRegulation ECNo1272/2008oftheEuropean Parliamentand ofthe Council1,or或类有致癌、致突变或生育毒性的物质,依据欧洲议会和理事会第1A IBCMR号法规附录第部分判断,或1272/2008VI3b substanceshaving endocrine-disrupting propertiesfor whichthereisscientificevidence ofprobable seriouseffects tohuman healthand whichare identifiedeither inaccordancewiththeprocedure setoutinArticle59of RegulationECNo1907/2006ofthe European ParliamentandoftheCouncil2or,once adelegated acthas beenadoptedbytheCommission pursuanttothefirstsubparagraphofArticle53ofRegulation EUNo528/2012oftheEuropeanParliamentandtheCouncil3,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号法规第条规定程序识别,或者委员会根据1907/200659欧洲议会和理事会第号法规第条第一段通过授权法案后,根据本法规528/201253规定之与人类健康相关准则识别.Justification regardingthepresenceofCMRand/or endocrine-disrupting substances关于存在The justificationforthepresenceofsuchsubstancesshallbebased upon:和/或内分泌干扰物的理由,存在此类物质的理由应基于CMRa ananalysis andestimation ofpotential patientoruserexposure tothesubstance;b ananalysis ofpossible alternativesubstances,materials or designs,including,where available,information aboutindependent research,peer-reviewed studies,scientific opinionsfrom relevantscientific committeesandananalysis ofthe availabilityofsuch alternatives;c argumentationastowhy possiblesubstance and/or materialsubstitutes,ifavailable,ordesignchanges,if feasible,are inappropriateinrelationto maintainingthefunctionality,performance andthebenefit-risk ratiosoftheproduct;including takingintoaccount iftheintendeduseofsuchdevicesincludes treatmentof childrenortreatment ofpregnantorbreastfeeding womenor treatmentof otherpatient groupsconsideredparticularly vulnerableto suchsubstances and/or materials;andd whereapplicableandavailable,the latestrelevantscientificcommitteeguidelines inaccordancewithSections
10.
4.
3.and
10.
4.
4.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;a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、b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;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c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;。