美国FDA 医疗器械体系法规QSR820中英文对照 zywen(1).doc

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美国FDA医疗器械体系法规QSR820中英文对照SubpartB--QualitySystemRequirements质量体系要求Sec.820.20Managementresponsibility.管理职责(a)Qualitypolicy.质量方针Managementwithexecutiveresponsibilityshallestablishitspolicyandobjectivesfor,andcommitmentto,quality.Managementwithexecutiveresponsibilityshallensurethatthequalitypolicyisunderstood,implemented,andmaintainedatalllevelsoftheorganization.具有管理职责的管理者应为质量确定方针和目标,并做出承诺。管理者还应保证质量方针能够在公司各个层级被充分的理解、实施和维护。(b)Organization.组织Eachmanufacturershallestablishandmaintainanadequateorganizationalstructuretoensurethatdevicesaredesignedandproducedinaccordancewiththerequirementsofthispart.每个制造商都应当建立一合适的组织结构用以保证设计和生产的器械符合本部分的要求。(1)Responsibilityandauthority.职责和权限Eachmanufacturershallestablishtheappropriateresponsibility,authority,andinterrelationofallpersonnelwhomanage,perform,andassessworkaffectingquality,andprovidetheindependenceandauthoritynecessarytoperformthesetasks.每个制造商都应当为具体管理、实施、考核影响质量工作的所有人员确立职责、权限和相互关系，并提供必要的独立性和权利来处理这些工作。(2)Resources.资源 Eachmanufacturershallprovideadequateresources,includingtheassignmentoftrainedpersonnel,formanagement,performanceofwork,andassessmentactivities,includinginternalqualityaudits,tomeettherequirementsofthispart.每个制造商都应当提供充足的资源，包括委派受训过的人员，这些人员用来进行管理、实施相应的工作、并评估相应的活动，这些活动包括为了满足本章节的要求而实施的内部的审计。(3)Managementrepresentative.管理者代表Managementwithexecutiveresponsibilityshallappoint,anddocumentsuchappointmentof,amemberofmanagementwho,irrespectiveofotherresponsibilities,shallhaveestablishedauthorityoverandresponsibilityfor:具有管理职责的管理者应当任命一定数量的管理者，并形成说面的任命文件。这些管理者不管有无其他职责，都至少要具有以下明确的职责和权限：(i)Ensuringthatqualitysystemrequirementsareeffectivelyestablishedandeffectivelymaintainedinaccordancewiththispart;and（i）确保质体系按照本部分的要求得以有效的确定、维护；并且(ii)Reportingontheperformanceofthequalitysystemtomanagementwithexecutiveresponsibilityforreview.(ii)向具有审核管理职责的管理者报告质量体系的运行情况。(c)Managementreview.管理审核（管理评审）Managementwithexecutiveresponsibilityshallreviewthesuitabilityandeffectivenessofthequalitysystematdefinedintervalsandwithsufficientfrequencyaccordingtoestablishedprocedurestoensurethatthequalitysystemsatisfiestherequirementsofthispartandthemanufacturer'sestablishedqualitypolicyandobjectives.Thedatesandresultsofqualitysystemreviewsshallbedocumented. 具有管理职责的管理者应当依据已经确定的规程（程序）在规定的时间间隔和足够的频率下定期对质量体系的有效性和适宜性进行审核，从而保证质量体系符合本部分的规定的要求以及符合制造商已经确立的质量方针和目标。质量体系审核的结果和日期应当予以记录。(d)Qualityplanning.质量策划Eachmanufacturershallestablishaqualityplanwhichdefinesthequalitypractices,resources,andactivitiesrelevanttodevicesthataredesignedandmanufactured.Themanufacturershallestablishhowtherequirementsforqualitywillbemet.每个制造商应当形成一个质量策划，明确与器械设计和制造相关的质量行为、资源和活动。制造商应当明确质量需求将如何得到满足。(e)Qualitysystemprocedures.质量体系规程（程序）Eachmanufacturershallestablishqualitysystemproceduresandinstructions.Anoutlineofthestructureofthedocumentationusedinthequalitysystemshallbeestablishedwhereappropriate.每个制造商应当明确质量体系程序和规范。相应的应当明确用于质量体系文件结构的概述。Sec.820.22Qualityaudit.质量审计Eachmanufacturershallestablishproceduresforqualityauditsandconductsuchauditstoassurethatthequalitysystemisincompliancewiththeestablishedqualitysystemrequirementsandtodeterminetheeffectivenessofthequalitysystem.Qualityauditsshallbeconductedbyindividualswhodonothavedirectresponsibilityforthemattersbeingaudited.Correctiveaction(s),includingareauditofdeficientmatters,shallbetakenwhennecessary.Areportoftheresultsofeachqualityaudit,andreaudit(s)wheretaken,shallbemadeandsuchreportsshallbereviewedbymanagementhaving responsibilityforthemattersaudited.Thedatesandresultsofqualityauditsandreauditsshallbedocumented.每个制造商都应当建立质量审计的规程，并实施相应的审计来保证质量体系符合已经明确的质量体系要求，并确定质量体系的有效性。质量审计应当由不直接从事即将被审计项目的人员进行。当必须实施纠正措施时，应当实施包括不合格项目重新审计的纠正措施。应当形成每次质量审计以及重新审计结果的报告，这些报告应当经过具有项目审计职责管理者的审核。质量审计和重审计的结果和日期应当予以记录。Sec.820.25Personnel.人员(a)General.概述Eachmanufacturershallhavesufficientpersonnelwiththenecessaryeducation,background,training,andexperiencetoassurethatallactivitiesrequiredbythispartarecorrectlyperformed.每个制造商都应当具有足够的人员，这些人员应当具有相应的教育经历、工作背景、经过必要的培训、具有实际的工作经验从而保证本章节要求的所有活动得以正确实施。(b)Training.培训Eachmanufacturershallestablishproceduresforidentifyingtrainingneedsandensurethatallpersonnelaretrainedtoadequatelyperformtheirassignedresponsibilities.Trainingshallbedocumented.每个制造商应当建立培训规程，识别培训需求，并保证所有受训人员能够充分执行赋予他们的职责。培训应当予以记录。（1）Aspartoftheirtraining,personnelshallbemadeawareofdevicedefectswhichmayoccurfromtheimproperperformanceoftheirspecificjobs. （1）作为他们培训的一部分，应使员工意识到他们的特殊工作中的不正确的操作可造成设备的缺陷。(2)Personnelwhoperformverificationandvalidationactivitiesshallbemadeawareofdefectsanderrorsthatmaybeencounteredaspartoftheirjobfunctions.（2）实施确认和验证的人员应当意识到，在其工作中会遇到缺陷和错误。SubpartA--GeneralProvisions总则Sec.820.1Scope范围(a)Applicability.适用性(1)Currentgoodmanufacturingpractice(CGMP)requirementsaresetforthinthisqualitysystemregulation.Therequirementsinthispartgovernthemethodsusedin,andthefacilitiesandcontrolsusedfor,thedesign,manufacture,packaging,labeling,storage,installation,andservicingofallfinisheddevicesintendedforhumanuse.TherequirementsinthispartareintendedtoensurethatfinisheddeviceswillbesafeandeffectiveandotherwiseincompliancewiththeFederalFood,Drug,andCosmeticAct(theact).Thispartestablishesbasicrequirementsapplicabletomanufacturersoffinishedmedicaldevices.Ifamanufacturerengagesinonlysomeoperationssubjecttotherequirementsinthispart,andnotinothers,thatmanufacturerneedonlycomplywiththoserequirementsapplicabletotheoperationsinwhichitisengaged.WithrespecttoclassIdevices,designcontrolsapplyonlytothosedeviceslistedin820.30(a)(2).Thisregulationdoesnotapplytomanufacturersofcomponentsorpartsoffinisheddevices,butsuchmanufacturersare encouragedtouseappropriateprovisionsofthisregulationasguidance.Manufacturersofhumanbloodandbloodcomponentsarenotsubjecttothispart,butaresubjecttopart606ofthischapter.（1）本质量体系法规阐明了现行生产质量管理规范（CGMP）的要求。本标准的要求管控所有的用于人用的终产品（器械）的设计、生产、包装、贴签、存储、安装和服务的方法、装置、控制。本标准要求的意图是保证成品器械安全有效并符合美国联邦食品，药品和化妆品法案。本标准确定的基本要求适用于医疗器械成品生产商。如果制造商从事的仅仅是本标准有要求服从的某些过程而不是其他过程，制造商仅需要符合适用于其实施的过程的要求即可。对遵从于I类器械要求的器械来讲，设计控制只适用于那些在820.30（a）（2）中列出的设备。本规例不适用于元件或部件的成品制造商，但鼓励这些制造商使用本标准的适当条文作为指南来使用。人体血液和血液成分的生产商是不受本标准的控制，但应遵循本章606部分法规的要求。Manufacturersofhumancells,tissues,andcellularandtissue-basedproducts(HCT/Ps),asdefinedin1271.3(d)ofthischapter,thataremedicaldevices(subjecttopremarketreviewornotification,orexemptfromnotification,underanapplicationsubmittedunderthedeviceprovisionsoftheactorunderabiologicalproductlicenseapplicationundersection351ofthePublicHealthServiceAct)aresubjecttothispartandarealsosubjecttothedonor-eligibilityproceduressetforthinpart1271subpartCofthischapterandapplicablecurrentgoodtissuepracticeproceduresinpart1271subpartDofthischapter.Intheeventofaconflictbetweenapplicableregulationsinpart1271andinotherpartsofthischapter,theregulationspecificallyapplicabletothedeviceinquestionshallsupersedethemoregeneral.在本章1271.3（d）中界定清楚的人体细胞、组织和以细胞和组织为基础的产品（HCT/Ps ）的生产商（适用于上市前审查或通知，或豁免通知，本法案器械规定申请下的、公共卫生服务法第351条规定的生物制品许可证申请下的）适用于本标准的要求、也适用于本章1271C部分额献血资格程序和本章1271D部份的现行良好组织实践规范。当出现1271部分相应法规与本章其他部分法规冲突时，特定应用于考虑之中的器械法规将取代更多的一般原则。(2)Theprovisionsofthispartshallbeapplicabletoanyfinisheddeviceasdefinedinthispart,intendedforhumanuse,thatismanufactured,imported,orofferedforimportinanyStateorTerritoryoftheUnitedStates,theDistrictofColumbia,ortheCommonwealthofPuertoRico.（2）本部分的规定将适用于任何本部分定义下的供人类使用的成品器械，不论其在美国（包含美国的任何州或地区、哥伦比亚特区和波多黎各自治区）生产、还是进口或提供进口的产品。(3)Inthisregulationtheterm"whereappropriate"isusedseveraltimes.Whenarequirementisqualifiedby"whereappropriate,"itisdeemedtobe"appropriate"unlessthemanufacturercandocumentjustificationotherwise.Arequirementis"appropriate"ifnonimplementationcouldreasonablybeexpectedtoresultintheproductnotmeetingitsspecifiedrequirementsorthemanufacturernotbeingabletocarryoutanynecessarycorrectiveaction.（3）在本法规中“适用时”出现过多次。除非制造商以文件的形式证明其理由充分，否则根据"whereappropriate,"只要认定有需求，这个需求就被认为是“适用的”。如果不执行预期结果将会导致产品不符合其特定要求，这时需求是“适用的”；或生产商不能实施必要的纠正措施，这时需求是“适用的”。(b)Thequalitysystemregulationinthispartsupplementsregulationsinotherpartsofthischapterexceptwhereexplicitlystatedotherwise.Intheeventofaconflictbetweenapplicableregulationsinthispartandinotherpartsofthischapter,the regulationsspecificallyapplicabletothedeviceinquestionshallsupersedeanyothergenerallyapplicablerequirements.（b）除另有明确规定外，本部分的质量体系法规是本章其他部分法规的补充。当本部分适用性法规与本章的其他部分法规发生冲突时，专属于考虑之中的器械法规将取代一般性适用法规要求。(c)Authority.权限Part820isestablishedandissuedunderauthorityofsections501,502,510,513,514,515,518,519,520,522,701,704,801,803oftheact(21U.S.C.351,352,360,360c,360d,360e,360h,360i,360j,360l,371,374,381,383).Thefailuretocomplywithanyapplicableprovisioninthispartrendersadeviceadulteratedundersection501(h)oftheact.Suchadevice,aswellasanypersonresponsibleforthefailuretocomply,issubjecttoregulatoryaction.PART820是在（501,502,510,513,514,515,518,519,520,522,701,704,801,803oftheact(21U.S.C.351,352,360,360c,360d,360e,360h,360i,360j,360l,371,374,381,383)章节下建立和出版。根据501（h）章节法案的要求，如果不符合本部分的任何适用条款将视为伪劣品。像这样的器械及对不符合负责的人都将受到法律起诉。(d)Foreignmanufacturers.国外制造商IfamanufacturerwhooffersdevicesforimportintotheUnitedStatesrefusestopermitorallowthecompletionofaFoodandDrugAdministration(FDA)inspectionoftheforeignfacilityforthepurposeofdeterminingcompliancewiththispart,itshallappearforpurposesofsection801(a)oftheact,thatthemethodsusedin,andthefacilitiesandcontrolsusedfor,thedesign,manufacture,packaging,labeling,storage,installation,orservicingofanydevicesproducedatsuchfacilitythatareofferedforimportintotheUnitedStatesdonotconformtotherequirementsofsection520(f)oftheactandthispart andthatthedevicesmanufacturedatthatfacilityareadulteratedundersection501(h)oftheact.如果向美国出口器械的国外制造商拒绝允许或同意FDA对国外的工厂实施为确定器械是否符合本章节的法规（Part820）所进行的检查，可按section801（a）条款对其提出诉讼。那么其设计、生产、包装、标签、贮存或服务中使用的方法设施以及控制将会被认为不符合本法令section520（f）和本部分（Part820）的要求，同时可依据本法令section501（h）条款裁定在此工厂内制造的产品为伪劣产品。(e)Exemptionsorvariances.豁免或特别许可(1)Anypersonwhowishestopetitionforanexemptionorvariancefromanydevicequalitysystemrequirementissubjecttotherequirementsofsection520(f)(2)oftheact.Petitionsforanexemptionorvarianceshallbesubmittedaccordingtotheproceduressetforthin10.30ofthischapter,theFDA'sadministrativeprocedures.GuidanceisavailablefromtheFoodandDrugAdministration,CenterforDevicesandRadiologicalHealth,DivisionofSmallManufacturers,InternationalandConsumerAssistance,10903NewHampshireAve.,Bldg.66,rm.4613,SilverSpring,MD20993-0002,1-800-638-2041or301-796-7100,FAX:301-847-8149.(1)任何人希望得到质量体系需求豁免或特别许可，应符合法令520(f)要求。审请豁免或特别许可的申请应当依据设置在本章10.30中的程序进行——FDA行政程序。可以从器械和辐射健康中心和小型制造商援助处获得指导。地址：10903NewHampshireAve.,Bldg.66,rm.4613,SilverSpring,MD20993-0002,1-800-638-2041or301-796-7100,FAX:301-847-8149.(2)FDAmayinitiateandgrantavariancefromanydevicequalitysystemrequirementwhentheagencydeterminesthatsuchvarianceisinthebestinterestofthepublichealth.Suchvariancewillremainineffectonlysolongasthereremainsapublichealthneedforthe deviceandthedevicewouldnotlikelybemadesufficientlyavailablewithoutthevariance.（2）当有关部门确定此种改变对公共健康非常有利时，FDA可以发起和允许来源于任何质量体系要求的特别许可。只要公众健康确实需要该器械，这样的特别许可将会一直维持有效。若没有特别许可，器械将不可能被生产，并得到充分的应用。Sec.820.3Definitions.定义(a)ActmeanstheFederalFood,Drug,andCosmeticAct,asamended(secs.201-903,52Stat.1040etseq.,asamended(21U.S.C.321-394)).Alldefinitionsinsection201oftheactshallapplytotheregulationsinthispart.（a）法案：指美国联邦食品、药品和化妆品法案，例如已经修订的（secs.201-903,52Stat.1040etseq.以及已经修订的（21U.S.C.321-394））。所有在法案201部分中的定义均适用于本文件。(b)Complaintmeansanywritten,electronic,ororalcommunicationthatallegesdeficienciesrelatedtotheidentity,quality,durability,reliability,safety,effectiveness,orperformanceofadeviceafteritisreleasedfordistribution.（b）抱怨：指产品放行销售后，任何与器械标识，质量，耐久性，可靠性，安全性，有效性，或性能有关的书面的、电子的，口头的不满。通常称其为顾客投诉或抱怨。(c)Componentmeansanyrawmaterial,substance,piece,part,software,firmware,labeling,orassemblywhichisintendedtobeincludedaspartofthefinished,packaged,andlabeleddevice.（c）部件（组分）：指任何意图作为终产品、包装产品、贴标产品一部分的原材料、物质、构件、零件、软件、固件、标签或其集合。(d)Controlnumbermeansanydistinctivesymbols,suchasadistinctivecombinationoflettersornumbers,orboth,fromwhichthehistoryofthemanufacturing,packaging, labeling,anddistributionofaunit,lot,orbatchoffinisheddevicescanbedetermined.（d）控制编码：指任何特定符号，例如字母或数字的特定组合，或字母与数字的特定组合，通过控制编码可以确定产品一个单元、批，或批产品的生产、包装、贴标以及销售历史。(e)Designhistoryfile(DHF)meansacompilationofrecordswhichdescribesthedesignhistoryofafinisheddevice.（e）设计历史文档：指描述终产品设计历史的汇编记录。(f)Designinputmeansthephysicalandperformancerequirementsofadevicethatareusedasabasisfordevicedesign.（f）设计输入：指作为器械设计基础并被使用的器械物理能需求。(g)Designoutputmeanstheresultsofadesigneffortateachdesignphaseandattheendofthetotaldesigneffort.Thefinisheddesignoutputisthebasisforthedevicemasterrecord.Thetotalfinisheddesignoutputconsistsofthedevice,itspackagingandlabeling,andthedevicemasterrecord.（g）设计输出：指在每个设计阶段结果以及在最后总的设计成果的结果。已完成的设计输出是DMR的基础，部最终完成的设计输出由器械、他的包装、贴标和DMR组成。(h)Designreviewmeansadocumented,comprehensive,systematicexaminationofadesigntoevaluatetheadequacyofthedesignrequirements,toevaluatethecapabilityofthedesigntomeettheserequirements,andtoidentifyproblems.（h）设计审核：指设计文件化的、综合性的、系统化的检查用以评估设计需求的充分性，评估符合这些需求的设计能力，并发现问题。(i)Devicehistoryrecord(DHR)meansacompilationofrecordscontainingtheproductionhistoryofafinisheddevice.（i）器械历史记录（DHR）：指包含终产品历史的汇编记录。 (j)Devicemasterrecord(DMR)meansacompilationofrecordscontainingtheproceduresandspecificationsforafinisheddevice.（j）器械主记录（DMR）：指包含终产品规程和标准的汇编记录。(k)Establishmeansdefine,document(inwritingorelectronically),andimplement.（k）建立：指定义、文件化（书面或电子形式）和实施。(l)Finisheddevicemeansanydeviceoraccessorytoanydevicethatissuitableforuseorcapableoffunctioning,whetherornotitispackaged,labeled,orsterilized.（l）终产品（成品器械）：指无论产品是否包装、贴标或灭菌，都能满足使用或功能性要求的器械及器械附件。(m)Lotorbatchmeansoneormorecomponentsorfinisheddevicesthatconsistofasingletype,model,class,size,composition,orsoftwareversionthataremanufacturedunderessentiallythesameconditionsandthatareintendedtohaveuniformcharacteristicsandqualitywithinspecifiedlimits.（m）批号和批次：指由一个类型、型号、级别、尺寸、构图或软件版本在相同的条件下在一定的时间内生产出来的具有均一特性和质量的一个或多个组件或终产品。(n)Managementwithexecutiveresponsibilitymeansthosesenioremployeesofamanufacturerwhohavetheauthoritytoestablishormakechangestothemanufacturer'squalitypolicyandqualitysystem.（n）具有最高管理职责的管理人员：指那些有权制定和改变制造商质量方针和质量体系的高级雇员。(o)Manufacturermeansanypersonwhodesigns,manufactures,fabricates,assembles,orprocessesafinisheddevice.Manufacturerincludesbutisnotlimitedtothosewhoperformthefunctionsofcontractsterilization,installation,relabeling,remanufacturing,repacking,orspecificationdevelopment,andinitialdistributorsofforeignentitiesperformingthese functions.（o）制造商：指任何设计、生产、组合、装配、加工终产品的人。制造商包括但不限于具有实施合同灭菌、安装、重贴签、再制造、重包装或标准开发的人，以及执行这些职能的国外组织的国内分销商。(p)Manufacturingmaterialmeansanymaterialorsubstanceusedinorusedtofacilitatethemanufacturingprocess,aconcomitantconstituent,orabyproductconstituentproducedduringthemanufacturingprocess,whichispresentinoronthefinisheddeviceasaresidueorimpuritynotbydesignorintentofthemanufacturer.（p）生产物料：指在制造过程中，任何用于或用在生产工艺、中间产品、产成品生产的材料或物质，制造商的意图和设计是将这些物质放在在终产品中出现或在终产品上，而非杂质或残留。(q)Nonconformitymeansthenonfulfillmentofaspecifiedrequirement.（q）不合格：指不能满足特定的要求。(r)Productmeanscomponents,manufacturingmaterials,in-processdevices,finisheddevices,andreturneddevices.（r）产品：指部件，生产物料、中间产品（工艺器械）、成品器械和返厂器械。(s)Qualitymeansthetotalityoffeaturesandcharacteristicsthatbearontheabilityofadevicetosatisfyfitness-for-use,includingsafetyandperformance.（s）质量：指赋予器械能力的特性和属性的总和，以满足包括安全性和性能的使用属性。(t)Qualityauditmeansasystematic,independentexaminationofamanufacturer'squalitysystemthatisperformedatdefinedintervalsandatsufficientfrequencytodeterminewhetherbothqualitysystemactivitiesandtheresultsofsuchactivitiescomplywithqualitysystemprocedures,thattheseproceduresareimplementedeffectively,andthat theseproceduresaresuitabletoachievequalitysystemobjectives.（t）质量审计（审核）：指制造商质量体系系统化、独立性的检查。通常在固定的时间间隔和足够的频率下实施从而确定是否质量体系活动和这些活动的结果符合质量体系规程（程序），确定这些程序是否有效的得以实施，确定这些程序适用于完成质量体系目标。(u)Qualitypolicymeanstheoverallintentionsanddirectionofanorganizationwithrespecttoquality,asestablishedbymanagementwithexecutiveresponsibility.（u）质量方针：由一个具有最高管理职责的管理人员确定的一个与质量体系有关的全面的组织宗旨和方向。(v)Qualitysystemmeanstheorganizationalstructure,responsibilities,procedures,processes,andresourcesforimplementingqualitymanagement.（v）质量体系：指用于实施质量管理的组织构架、职责、规程（程序）、工艺（过程）和资源。(w)Remanufacturermeansanypersonwhoprocesses,conditions,renovates,repackages,restores,ordoesanyotheracttoafinisheddevicethatsignificantlychangesthefinisheddevice'sperformanceorsafetyspecifications,orintendeduse.（w）再造商：对其完成的产品进行重新加工、翻新、重包装、修复或进行的别的其他活动的拥有工艺和条件的任何人。这些设备显然已经改变了制造完成后器械的性能或安全标准，或预期用途。(x)ReworkmeansactiontakenonanonconformingproductsothatitwillfulfillthespecifiedDMRrequirementsbeforeitisreleasedfordistribution.（x）返工：指对一个不合格品进行处理使其在放行用于销售前符合特定的DMR要求。(y)Specificationmeansanyrequirementwithwhichaproduct,process,service,orotheractivitymustconform. （y）标准（规范）：指产品、工艺、服务或其他活动所必须符合的任何要求。(z)Validationmeansconfirmationbyexaminationandprovisionofobjectiveevidencethattheparticularrequirementsforaspecificintendedusecanbeconsistentlyfulfilled.（Z）验证：指通过检查或提供客观证据来证实器械预期用途的特定要求能够持续的得到满足。(1)Processvalidationmeansestablishingbyobjectiveevidencethataprocessconsistentlyproducesaresultorproductmeetingitspredeterminedspecifications.（1）工艺验证（过程确认）：指指通过客观的证据表明该工艺能够持续的生产出符合其事先确定的标准要求的产品或结果。(2)Designvalidationmeansestablishingbyobjectiveevidencethatdevicespecificationsconformwithuserneedsandintendeduse(s).（2）设计验证：指通过客观的证据表明设备标准符合用户需求和预期用途。(aa)Verificationmeansconfirmationbyexaminationandprovisionofobjectiveevidencethatspecifiedrequirementshavebeenfulfilled.（aa）确认：指通过检查和提供客观证据来证实已满足规定的要求。(bb)Humancell,tissue,orcellularortissue-basedproduct(HCT/P)regulatedasadevicemeansanHCT/Pasdefinedin1271.3(d)ofthischapterthatdoesnotmeetthecriteriain1271.10(a)andthatisalsoregulatedasadevice.（bb）HCT/P：人细胞、组织或以细胞或组织为基础的产品按器械进行管理：指明确在本章中1271.3（d）的HCT/P虽然不符合1271.10(a)的标准，但是仍然按照器械来监管。(cc)Uniquedeviceidentifier(UDI)meansanidentifierthatadequatelyidentifiesadevicethroughitsdistributionandusebymeetingtherequirementsof830.20ofthischapter.Auniquedeviceidentifieriscomposedof:(1)Adeviceidentifier--amandatory,fixedportionofaUDIthatidentifiesthespecific versionormodelofadeviceandthelabelerofthatdevice;and(2)Aproductionidentifier--aconditional,variableportionofaUDIthatidentifiesoneormoreofthefollowingwhenincludedonthelabelofthedevice:(i)Thelotorbatchwithinwhichadevicewasmanufactured;(ii)Theserialnumberofaspecificdevice;(iii)Theexpirationdateofaspecificdevice;(iv)Thedateaspecificdevicewasmanufactured.(v)ForanHCT/Pregulatedasadevice,thedistinctidentificationcoderequiredby1271.290(c)ofthischapter.器械唯一标识(UDI):是指在其销售和使用时用以充分标记器械的一种标识，从而满足本文83.20章节的要求。器械的唯一标识由以下内容构成：（1）一个器械标识：一个强制性的要求，作为UDI固定的一部分，显示器械以及该器械贴标机的特定版本或型号的标签。并且（2）一个产品标识：一个条件性的，作为UDI可以变化的一部分，显示在器械标签上的一个或多个下述内容的标签：（i）制造器械的“批号”或“批量”；（ii）特殊器械的序列批号；（iii）特殊器械有效期（货架寿命、过期日）（iv）特殊器械的生产日期。（v）对于按器械管理的HCT/P产品，本章中1271.290（c）所要求的独特识别码。Sec.820.5Qualitysystem.质量体系Eachmanufacturershallestablishandmaintainaqualitysystemthatisappropriateforthespecificmedicaldevice(s)designedormanufactured,andthatmeetstherequirementsofthispart. 每个制造商应当建立和维护一个质量体系，适用于特定器械设计或制造，并且符合本部分的要求。SubpartC--DesignControls设计控制Sec.820.30Designcontrols.设计控制(a)General.总则(1)EachmanufacturerofanyclassIIIorclassIIdevice,andtheclassIdeviceslistedinparagraph(a)(2)ofthissection,shallestablishandmaintainprocedurestocontrolthedesignofthedeviceinordertoensurethatspecifieddesignrequirementsaremet.(2)ThefollowingclassIdevicesaresubjecttodesigncontrols:(i)Devicesautomatedwithcomputersoftware;and(ii)Thedeviceslistedinthefollowingchart.（1）II类和III类器械，以及在本章节（a）（2）清单下的I类器械制造商应当建立和维护一个控制器械设计的规程，从而保证特定的设计需求得以实现。（2）以下的I类器械应当进行设控制：(i)由计算机软件自动操作的器械；并且(ii)以及以下表格所列的器械。Section章节Device器械868.6810Catheter,TracheobronchialSuction.气管插管878.4460Glove,Surgeon's.外科手套880.6760Restraint,Protective. 保护性约束器械892.5650System,Applicator,Radionuclide,Manual.放射性药物人工给药系统892.5740Source,RadionuclideTeletherapy.放疗用放射源(b)Designanddevelopmentplanning.设计和开发计划（策划）Eachmanufacturershallestablishandmaintainplansthatdescribeorreferencethedesignanddevelopmentactivitiesanddefineresponsibilityforimplementation.Theplansshallidentifyanddescribetheinterfaceswithdifferentgroupsoractivitiesthatprovide,orresultin,inputtothedesignanddevelopmentprocess.Theplansshallbereviewed,updated,andapprovedasdesignanddevelopmentevolves.每个制造商应当建立和维护一个描述或包括设计和开发活动以及定期实施职责的策划书。策划书应当界定和描述内部为设计开发所设定的不同组别或活动之间的联系，这些活动包括输入、产生结果等。该策划随着设计和开发的推进进行审核、更新，并经批准。(c)Designinput.设计输入Eachmanufacturershallestablishandmaintainprocedurestoensurethatthedesignrequirementsrelatingtoadeviceareappropriateandaddresstheintendeduseofthedevice,includingtheneedsoftheuserandpatient.Theproceduresshallincludeamechanismforaddressingincomplete,ambiguous,orconflictingrequirements.Thedesigninputrequirementsshallbedocumentedandshallbereviewedandapprovedbyadesignatedindividual(s).Theapproval,includingthedateandsignatureoftheindividual(s)approvingtherequirements,shallbedocumented. 每个制造商应当建立和维护一个程序来保证与设备相关的设计要求符合设备预期使用，包括病人和使用者的需求。该规程应当包括一个能够处理不完整、不明确、矛盾需求的途径。设计输入的需求应当指定人员进行记录，并审核和批准。该批准（其中包括批准需求的人员的签字和日期）应当予以记录。(d)Designoutput.设计输出Eachmanufacturershallestablishandmaintainproceduresfordefininganddocumentingdesignoutputintermsthatallowanadequateevaluationofconformancetodesigninputrequirements.Designoutputproceduresshallcontainormakereferencetoacceptancecriteriaandshallensurethatthosedesignoutputsthatareessentialfortheproperfunctioningofthedeviceareidentified.Designoutputshallbedocumented,reviewed,andapprovedbeforerelease.Theapproval,includingthedateandsignatureoftheindividual(s)approvingtheoutput,shallbedocumented.每个制造商应当确定和维护一个程序，用于界定和记录设计输出，从而给予一个符合设计输入要求的充分评估。设计输出规程应当包含或考虑可接受标准并且应保证这些设计输出得以确定。因为这些输出对设备正常运作来说非常重要。设计输出应当文件化，并在其放行前得以审核和批准。该批准（其中包括批准输出的人员的签字和日期）应当予以记录。(e)Designreview.设计审核Eachmanufacturershallestablishandmaintainprocedurestoensurethatformaldocumentedreviewsofthedesignresultsareplannedandconductedatappropriatestagesofthedevice'sdesigndevelopment.Theproceduresshallensurethatparticipantsateachdesignreviewincluderepresentativesofallfunctionsconcernedwiththedesignstagebeingreviewedandanindividual(s)whodoesnothavedirectresponsibilityforthedesignstagebeingreviewed,aswellasanyspecialistsneeded.Theresultsofadesignreview,includingidentificationofthedesign,thedate,andtheindividual(s)performingthereview, shallbedocumentedinthedesignhistoryfile(theDHF).每个制造商应当建立和维护一个规程用以保证在器械设计开发的相应阶段设计结果正式文件化的审核得以策划和实施。该规程应当保证在每次设计审核中的参与者都包括了设计阶段的所有职能的代表，在设计阶段中不负有直接责任的一些个人，以及所需的专家。设计审核的结果应当记录在设计历史文档中。这些结果包括设计识别、日期和实施审核的人员。(f)Designverification.设计确认Eachmanufacturershallestablishandmaintainproceduresforverifyingthedevicedesign.Designverificationshallconfirmthatthedesignoutputmeetsthedesigninputrequirements.Theresultsofthedesignverification,includingidentificationofthedesign,method(s),thedate,andtheindividual(s)performingtheverification,shallbedocumentedintheDHF.每个制造商应当建立和维护一个程序用于确认器械的设计。设计确认应当证明设计输出符合设计输入要求。设计确认的结果应当记录在设计历史文档中。这些结果包括设计识别、方法学、日期和实施审核的人员。(g)Designvalidation.设计验证Eachmanufacturershallestablishandmaintainproceduresforvalidatingthedevicedesign.Designvalidationshallbeperformedunderdefinedoperatingconditionsoninitialproductionunits,lots,orbatches,ortheirequivalents.Designvalidationshallensurethatdevicesconformtodefineduserneedsandintendedusesandshallincludetestingofproductionunitsunderactualorsimulateduseconditions.Designvalidationshallincludesoftwarevalidationandriskanalysis,whereappropriate.Theresultsofthedesignvalidation,includingidentificationofthedesign,method(s),thedate,andtheindividual(s)performingthevalidation,shallbedocumentedintheDHF. 每个制造商应当建立和维护一个程序用于验证器械的设计。设计验证应当在规定的条件下（最初的产品、批次或其等价物）进行。设计验证应当保证器械符合之前界定好的使用者需求和预期使用要求，设计验证应当包括在实际或等效的使用条件下的产品单元的测试。设计验证应当包括适当的软件验证和风险分析。包括设计的确定、方法学、日期、实施验证的人员的设计验证结果应当记录在设计历史文档中。(h)Designtransfer.设计转换Eachmanufacturershallestablishandmaintainprocedurestoensurethatthedevicedesigniscorrectlytranslatedintoproductionspecifications.每个制造商应当建立和维护一个程序来保证器械设计正确的转换成产品标准。(i)Designchanges.设计变更Eachmanufacturershallestablishandmaintainproceduresfortheidentification,documentation,validationorwhereappropriateverification,review,andapprovalofdesignchangesbeforetheirimplementation.每个制造商应当建立和维护一个程序在变更实施前用以对设计变更进行相应的识别、记录、验证或相应的确认、审核和批准。(j)Designhistoryfile.设计历史文档EachmanufacturershallestablishandmaintainaDHFforeachtypeofdevice.TheDHFshallcontainorreferencetherecordsnecessarytodemonstratethatthedesignwasdevelopedinaccordancewiththeapproveddesignplanandtherequirementsofthispart.每个制造商应当为每个类型的器械建立和维护一个设计历史文档，该历史文档应当包括或涉及必须的记录来保证设计已经依据批准的设计方案和本章节的要求进行了相应的开发。SubpartD--DocumentControls 文件控制Sec.820.40Documentcontrols.文件控制 Eachmanufacturershallestablishandmaintainprocedurestocontrolalldocumentsthatarerequiredbythispart.Theproceduresshallprovideforthefollowing:  制造商应当建立和维护相应的规程用于控制本标准要求下的所有文件。规程应包括：(a)Documentapprovalanddistribution.文件的批准和下发Eachmanufacturershalldesignateanindividual(s)toreviewforadequacyandapprovepriortoissuancealldocumentsestablishedtomeettherequirementsofthispart.Theapproval,includingthedateandsignatureoftheindividual(s)approvingthedocument,shallbedocumented.Documentsestablishedtomeettherequirementsofthispartshallbeavailableatalllocationsforwhichtheyaredesignated,used,orotherwisenecessary,andallobsoletedocumentsshallbepromptlyremovedfromallpointsofuseorotherwisepreventedfromunintendeduse.  制造商应当指定相应的人员对所有符合本标准要求的文件在其生效前进行充分审核,并批准。包括人员的签字和日期的批准应当予以记录。符合本标准要求的经批准过的文件应当在指定的，或其他必要的地点进行使用，所有已作废的文件应及时从防止其意外使用的所有使用点或以其它地点进行回收(removed)。(b)Documentchanges.文件变更Changestodocumentsshallbereviewedandapprovedanindividual(s)inthesamefunctionororganizationthatperformedtheoriginalreviewandapproval,unlessspecificallydesignatedotherwise.Approvedchangesshallbecommunicatedtotheappropriatepersonnelinatimelymanner.Eachmanufacturershallmaintainrecordsofchangestodocuments.Changerecordsshallincludeadescriptionofthechange,identificationoftheaffecteddocuments,thesignatureoftheapprovingindividual(s),theapprovaldate,andwhenthechangebecomeseffective.   除非有特殊规定，否则应当由最初审核和批准该文件的部门或机构对变更后的文件进行重新审核和批准。经批准的变更应当及时地通知相应的人员。制造商应当保存文件变更的记录。文件变更的记录包括了变化部分的描述、受影响文件的标识、批准人员的签字、批准的日期、以及变更生效的时间。SubpartE--PurchasingControls采购控制Sec.820.50Purchasingcontrols采购控制Eachmanufacturershallestablishandmaintainprocedurestoensurethatallpurchasedorotherwisereceivedproductandservicesconformtospecifiedrequirements.  制造商应当建立和维护相应的规程来保证所有的采购的和其他接收的产品和服务符合规定的要求。(a)Evaluationofsuppliers,contractors,andconsultants.供应商的评估Eachmanufacturershallestablishandmaintaintherequirements,includingqualityrequirements,thatmustbemetbysuppliers,contractors,andconsultants.Eachmanufacturershall:  制造商应当建立和维护相应的求要（包括必须被供应商所遵守的质量要求），制造商应当：(1)Evaluateandselectpotentialsuppliers,contractors,andconsultantsonthebasisoftheirabilitytomeetspecifiedrequirements,includingqualityrequirements.Theevaluationshallbedocumented.  基于符合指定要求（包括质量要求）的能力来评估和选择潜在的供应商。评估应当予以记录。(2)Definethetypeandextentofcontroltobeexercisedovertheproduct,services,suppliers,contractors,andconsultants,basedontheevaluationresults.  基于评估结果，明确覆盖供应商控制的类型和程度。(3)Establishandmaintainrecordsofacceptablesuppliers,contractors,andconsultants.   建立并维护合格供应商的记录。(b)Purchasingdata.采购文件Eachmanufacturershallestablishandmaintaindatathatclearlydescribeorreferencethespecifiedrequirements,includingqualityrequirements,forpurchasedorotherwisereceivedproductandservices.Purchasingdocumentsshallinclude,wherepossible,anagreementthatthesuppliers,contractors,andconsultantsagreetonotifythemanufacturerofchangesintheproductorservicesothatmanufacturersmaydeterminewhetherthechangesmayaffectthequalityofafinisheddevice.Purchasingdatashallbeapprovedinaccordancewith820.40.  制造商应当建立和维护清楚描述或引用特定要求的资料。包括用于采购的、其他接收的产品和服务的质量要求。如果可能，采购文件应包括供应商同意向制造商告知其产品、服务变更的相关协议以便制造商可以确定变更是否会影响成品器械的质量。应依据820.40的相关要求批准采购资料。SubpartF--IdentificationandTraceability标识和可追溯性Sec.820.60Identification.标识Eachmanufacturershallestablishandmaintainproceduresforidentifyingproductduringallstagesofreceipt,production,distribution,andinstallationtopreventmixups.  制造商应当建立和维护标识程序,用以在接收、生产、销售和安装的所有阶段识别产品来避免混淆。Sec.820.65Traceability.可追溯性Eachmanufacturerofadevicethatisintendedforsurgicalimplantintothebodyortosupportorsustainlifeandwhosefailuretoperformwhenproperlyusedinaccordancewithinstructionsforuseprovidedinthelabelingcanbereasonablyexpectedtoresultinasignificantinjurytotheuser）shallestablishandmaintainproceduresforidentifyingwitha controlnumbereachunit,lot,orbatchoffinisheddevicesandwhereappropriatecomponents.Theproceduresshallfacilitatecorrectiveaction.SuchidentificationshallbedocumentedintheDHR.  当依据标签上的外科植入体内的或用以维持生命体征的器械说明书使用器械时，由于操作不当（failuretoperform）可能会导致使用者受到的重大的伤害，所以制造商应当建立和维护可追溯性规程，用成品器械或是相应组分的每个单元、批或批的控制号码作为标识。此程序有助于纠正措施。在器械历史记录用应当记录该标标识。SubpartG--ProductionandProcessControls生产和工艺控制Sec.820.70Productionandprocesscontrols.生产和工艺控制(a)General.Eachmanufacturershalldevelop,conduct,control,andmonitorproductionprocessestoensurethatadeviceconformstoitsspecifications.Wheredeviationsfromdevicespecificationscouldoccurasaresultofthemanufacturingprocess,themanufacturershallestablishandmaintainprocesscontrolproceduresthatdescribeanyprocesscontrolsnecessarytoensureconformancetospecifications.Whereprocesscontrolsareneededtheyshallinclude:  （a）概述。制造商应当开发、实施、控制和监控生产工艺来保证器械符合其标准。在制造过程中可能会出现偏离标准的偏差，制造商应当建立和维护描述了必要工艺控制的工艺控制规程来保证符合标准要求。工艺控制应包括如下内容：(1)Documentedinstructions,standardoperatingprocedures(SOP's),andmethodsthatdefineandcontrolthemannerofproduction;  （1）文件化的指导书、标准操作规程、以及界定和控制生产方式的方法；(2)Monitoringandcontrolofprocessparametersandcomponentanddevicecharacteristicsduringproduction;   （2）在生产期间对器械特性、组件、工艺参数的监控和控制；(3)Compliancewithspecifiedreferencestandardsorcodes;  （3）符合特定的标准和法规；(4)Theapprovalofprocessesandprocessequipment;and  （4）工艺和工艺设备的确认；和(5)Criteriaforworkmanshipwhichshallbeexpressedindocumentedstandardsorbymeansofidentifiedandapprovedrepresentativesamples.  （5）标准的工艺，应在文件化的标准中加以明确或通过确定好的和确认过的样件方式进行。(b)Productionandprocesschanges.Eachmanufacturershallestablishandmaintainproceduresforchangestoaspecification,method,process,orprocedure.Suchchangesshallbeverifiedorwhereappropriatevalidatedaccordingto820.75,beforeimplementationandtheseactivitiesshallbedocumented.Changesshallbeapprovedinaccordancewith820.40.  （b）生产和工艺的变更。制造商应当建立和维护一个用一于标准、方法、工艺、规程的变更规程。变更在其实施前应当依据820.75经过适当的确认和验证。这些措施应当予以记录。变更应当依据820.40的要求经过批准。(c)Environmentalcontrol.Whereenvironmentalconditionscouldreasonablybeexpectedtohaveanadverseeffectonproductquality,themanufacturershallestablishandmaintainprocedurestoadequatelycontroltheseenvironmentalconditions.Environmentalcontrolsystem(s)shallbeperiodicallyinspectedtoverifythatthesystem,includingnecessaryequipment,isadequateandfunctioningproperly.Theseactivitiesshallbedocumentedandreviewed.  （c ）环境控制。如果环境条件可能对产品质量有不利影响时，制造商应当建立和维护充分的控制这些环境的规程。应当定期的、对环境控制系统进行检查来保证包括必要设备的系统处于良好的工作状态。这些措施应当予以记录和审核。(d)Personnel.Eachmanufacturershallestablishandmaintainrequirementsforthehealth,cleanliness,personalpractices,andclothingofpersonnelifcontactbetweensuchpersonnelandproductorenvironmentcouldreasonablybeexpectedtohaveanadverseeffectonproductquality.Themanufacturershallensurethatmaintenanceandotherpersonnelwhoarerequiredtoworktemporarilyunderspecialenvironmentalconditionsareappropriatelytrainedorsupervisedbyatrainedindividual.ectonproductquality.  （d）人员。如果人和环境或产品接触会直接影响产品质量。那么制造商应当建立和维护用于健康，卫生，人员操作和人员着装有关的要求。并保证维修人员及其他工作在有要求的特定环境下的人员经过适当的培训和考核。(e)Contaminationcontrol.Eachmanufacturershallestablishandmaintainprocedurestopreventcontaminationofequipmentorproductbysubstancesthatcouldreasonablybeexpectedtohaveanadverseeffectonproductquality.（e）污染控制。制造商应当建立和维护防污染的规程来防止对对产品质量有直接影响的物质污染设备和产品。保证所有用于生产工艺的设备符合特定的要求。(f)Buildings.Buildingsshallbeofsuitabledesignandcontainsufficientspacetoperformnecessaryoperations,preventmixups,andassureorderlyhandling.  （f）建筑。建筑应该当经过适当的设计，拥有足够的空间来实施必要的操作，防止混淆，确保有序操作。(g)Equipment.Eachmanufacturershallensurethatallequipmentusedinthemanufacturingprocessmeetsspecifiedrequirementsandisappropriatelydesigned,constructed,placed,andinstalledtofacilitatemaintenance,adjustment,cleaning,anduse.   （g）设备。制造商应当保证所有用于生产工艺的设备符合特定的要求。其设计、操作、放置、安装便于进行维护、维修、清洁和使用。(1)Maintenanceschedule.Eachmanufacturershallestablishandmaintainschedulesfortheadjustment,cleaning,andothermaintenanceofequipmenttoensurethatmanufacturingspecificationsaremet.Maintenanceactivities,includingthedateandindividual(s)performingthemaintenanceactivities,shallbedocumented.  （1）维护保养计划。制造商应当建立和维护用于校准、清洁、或设备的其他维护来保证符合制造标准的要求。包括维护日期和实施维护的人员的维护活动都应当予以记录。(2)Inspection.Eachmanufacturershallconductperiodicinspectionsinaccordancewithestablishedprocedurestoensureadherencetoapplicableequipmentmaintenanceschedules.Theinspections,includingthedateandindividual(s)conductingtheinspections,shallbedocumented.  （2）检查。制造商应当依据所确定的规程实施相应的审核来保证设备维护计划得以实施。包括检查日期和实施检查人员的检查都应当予以记录。(3)Adjustment.Eachmanufacturershallensurethatanyinherentlimitationsorallowabletolerancesarevisiblypostedonornearequipmentrequiringperiodicadjustmentsorarereadilyavailabletopersonnelperformingtheseadjustments.  （3）校准。组织应确保将规定的限制或允许的误差粘贴在应定期校准的设备上，或放在其附近，或张贴到实施校准工作的人员容易看到的地方。(h)Manufacturingmaterial.Whereamanufacturingmaterialcouldreasonablybeexpectedtohaveanadverseeffectonproductquality,themanufacturershallestablishandmaintainproceduresfortheuseandremovalofsuchmanufacturingmaterialtoensurethatitisremovedorlimitedtoanamountthatdoesnotadverselyaffectthedevice'squality.The removalorreductionofsuchmanufacturingmaterialshallbedocumented.  （h）生产原材料。当生产原材料对产品质量有严重影响时，制造商应当建立和维护一个用于使用和去除此种物料的程序从而保证物料被去除或降低到一个不会严重影响器械质量的相应限度。生产原材料的去除和降低应当予以记录。(i)Automatedprocesses.Whencomputersorautomateddataprocessingsystemsareusedaspartofproductionorthequalitysystem,themanufacturershallvalidatecomputersoftwareforitsintendeduseaccordingtoanestablishedprotocol.Allsoftwarechangesshallbevalidatedbeforeapprovalandissuance.Thesevalidationactivitiesandresultsshallbedocumented.  （i）自动化工艺。当使用计算机或自动化数据工艺系统作为生产或质量体系统的一部分时，生产商应当依据确定的方案来验证其预期使用的计算机系统软件。在计算机系统变更得到批准和发布前都应当经过验证。验证的活动和结果应当予以记录。Sec.820.72Inspection,measuring,andtestequipment.检测、测量和试验设备(a)Controlofinspection,measuring,andtestequipment.检测、测量和试验设备控制Eachmanufacturershallensurethatallinspection,measuring,andtestequipment,includingmechanical,automated,orelectronicinspectionandtestequipment,issuitableforitsintendedpurposesandiscapableofproducingvalidresults.Eachmanufacturershallestablishandmaintainprocedurestoensurethatequipmentisroutinelycalibrated,inspected,checked,andmaintained.Theproceduresshallincludeprovisionsforhandling,preservation,andstorageofequipment,sothatitsaccuracyandfitnessforusearemaintained.Theseactivitiesshallbedocumented.   制造商应保证包括手工，自动化或电子的检测和试验设备在内的所有检测、测量和试验设备都符合其预期使用的目的，并且能够得到有效的结果。制造商应当建立和维护一个规程来保证设备经过常规的校准、检验、检查和维护。该程序应当包括设备搬运、保管和存储。以至于其使用的适应性和准确度得以维护。这些活动应当予以记录。(b)Calibration.Calibrationproceduresshallincludespecificdirectionsandlimitsforaccuracyandprecision.Whenaccuracyandprecisionlimitsarenotmet,thereshallbeprovisionsforremedialactiontoreestablishthelimitsandtoevaluatewhethertherewasanyadverseeffectonthedevice'squality.Theseactivitiesshallbedocumented.  （b）校准  校准程序应当包括准确性和精确度的特定说明和限制。当准确性和精确度的限度无法得到满足时，应该当重新确认该限度并评估是否对器械的质量产生严重的影响。这些活动应当予以记录。(1)Calibrationstandards.Calibrationstandardsusedforinspection,measuring,andtestequipmentshallbetraceabletonationalorinternationalstandards.Ifnationalorinternationalstandardsarenotpracticaloravailable,themanufacturershalluseanindependentreproduciblestandard.Ifnoapplicablestandardexists,themanufacturershallestablishandmaintainanin-housestandard.  （1）校准标准 用于检测、测量和检查试验设备的校准标准应当溯源到国际或国家标准。如果国家或国际标准品不使用或不可用。制造商应使用一个独立的可重现的校准标准。如果没有合适的校准标准，企业应建立和维护一个企业内部标准。(2)Calibrationrecords.Theequipmentidentification,calibrationdates,theindividualperformingeachcalibration,andthenextcalibrationdateshallbedocumented.Theserecordsshallbedisplayedonorneareachpieceofequipmentorshallbereadilyavailabletothepersonnelusingsuchequipmentandtotheindividualsresponsibleforcalibratingtheequipment.  （2）校准记录   设备标识、校准日期、实施校准的人员、下次校准的日期应当予以记录。这些记录应当很容易被使用该设备的人员以及校准该设备的人员观察到。并且应当放置于设备附近，或悬挂于设备上。Sec.820.75Processvalidation.工艺验证(a)Wheretheresultsofaprocesscannotbefullyverifiedbysubsequentinspectionandtest,theprocessshallbevalidatedwithahighdegreeofassuranceandapprovedaccordingtoestablishedprocedures.Thevalidationactivitiesandresults,includingthedateandsignatureoftheindividual(s)approvingthevalidationandwhereappropriatethemajorequipmentvalidated,shallbedocumented.  （a）当工艺结果不能通过其后的检验和试验进行充分的确认时，应当用高级别的控制对工艺进行验证。并依据确定的程序来批准该工艺。包括批准验证人员署名和签署日期的在内的验证活动和验证结果以及主要经过了确认的设备，都应当予以记录。(b)Eachmanufacturershallestablishandmaintainproceduresformonitoringandcontrolofprocessparametersforvalidatedprocessestoensurethatthespecifiedrequirementscontinuetobemet.  （b）制造商应当建立和维护一个用以监控和控制用于验证过的工艺当中的工艺参数的规程来保证持续符合特定要求。(1)Eachmanufacturershallensurethatvalidatedprocessesareperformedbyqualifiedindividual(s).  （1）制造商应保证经过验证的工艺由经过确认的人员来实施。(2)Forvalidatedprocesses,themonitoringandcontrolmethodsanddata,thedateperformed,and,whereappropriate,theindividual(s)performingtheprocessorthemajorequipmentusedshallbedocumented.  （2 ）对于验证的工艺而言，实施的日期、控制和监控的方法和数据以及相应的实施工艺的人员或主要使用的设备都应当予以记录。(c)Whenchangesorprocessdeviationsoccur,themanufacturershallreviewandevaluatetheprocessandperformrevalidationwhereappropriate.Theseactivitiesshallbedocumented.（c）当出现变更或工艺偏差时，制造商应当审核和评估该工艺并适当的进行再确认。这些活动应当予以记录。SubpartH--AcceptanceActivities 验收措施Sec.820.80Receiving,in-process,andfinisheddeviceacceptance.进货、中间品和成品器械的验收(a)General.Eachmanufacturershallestablishandmaintainproceduresforacceptanceactivities.Acceptanceactivitiesincludeinspections,tests,orotherverificationactivities.  (a)概述。制造商应当建立和维护用于验收措施的规程。验收活动包括检验、试验或其他确认活动。(b)Receivingacceptanceactivities.Eachmanufacturershallestablishandmaintainproceduresforacceptanceofincomingproduct.Incomingproductshallbeinspected,tested,orotherwiseverifiedasconformingtospecifiedrequirements.Acceptanceorrejectionshallbedocumented.  （b）进货验收措施。制造商应当建立和维护用于验收进货产品的规程。进货产品应当经过检测、测试或其他确认方式，并满足其特定要求。验收或拒收应当予以记录。(c)In-processacceptanceactivities.Eachmanufacturershallestablishandmaintainacceptanceprocedures,whereappropriate,toensurethatspecifiedrequirementsforin-processproductaremet.Suchproceduresshallensurethat in-processproductiscontrolleduntiltherequiredinspectionandtestsorotherverificationactivitieshavebeencompleted,ornecessaryapprovalsarereceived,andaredocumented.  （c）中间产品的验收措施。制造商应当建立和维护相应的中间品验收规程来保证中间产品符合其特定要求。该规程应当保证直到所需要的检测、试验或其他确认活动得以实施或得到必须的批准，中间产品一直处于受控状态。所有的控制措施应当予以记录。(d)Finalacceptanceactivities.Eachmanufacturershallestablishandmaintainproceduresforfinisheddeviceacceptancetoensurethateachproductionrun,lot,orbatchoffinisheddevicesmeetsacceptancecriteria.Finisheddevicesshallbeheldinquarantineorotherwiseadequatelycontrolleduntilreleased.Finisheddevicesshallnotbereleasedfordistributionuntil:  （d）成品的验收措施。制造商应当建立和维护成品器械验收的规程来保证成品器械批或批、每个产品的运行符合其验收标准。成品器械在其放行前应当单独存放或其他适当的方式进行控制。成品器械直到下述工作完成后才可以放行用于销售：(1)TheactivitiesrequiredintheDMRarecompleted;  （1）DMR要求的验收得以完成；(2)theassociateddataanddocumentationisreviewed;  （2）相应的数据和文件已经得到审核；(3)thereleaseisauthorizedbythesignatureofadesignatedindividual(s);and  （3）经过有权限的人员签名批准放行；并(4)theauthorizationisdated.  （4）批准日期得以记录。(e)Acceptancerecords.Eachmanufacturershalldocumentacceptanceactivitiesrequiredbythispart.Theserecordsshallinclude:   （e）验收记录。制造商应当记录本部分要求的验收措施。记录应当包括：(1)Theacceptanceactivitiesperformed;实施的验收措施；(2)thedatesacceptanceactivitiesareperformed;实施验收措施的日期；(3)theresults;验收结果；(4)thesignatureoftheindividual(s)conductingtheacceptanceactivities;and实施验收活动人员；并(5)whereappropriatetheequipmentused.TheserecordsshallbepartoftheDHR.相应的使用设备。这些记录将作为DHR的一部分。Sec.820.86Acceptancestatus.验收状态Eachmanufacturershallidentifybysuitablemeanstheacceptancestatusofproduct,toindicatetheconformanceornonconformanceofproductwithacceptancecriteria.Theidentificationofacceptancestatusshallbemaintainedthroughoutmanufacturing,packaging,labeling,installation,andservicingoftheproducttoensurethatonlyproductwhichhaspassedtherequiredacceptanceactivitiesisdistributed,used,orinstalled.  制造商应当通过适当的方式来标识产品的验收状态，来标明是否符验收标准。验收状态的标识应当贯穿于产品生产、包装、贴标、安装、服务的全过程从而保证只有经过符合验收措施要求的产品才可以销售、使用或安装。SubpartI--NonconformingProduct不合格品Sec.820.90Nonconformingproduct.不合格品(a)Controlofnonconformingproduct.Eachmanufacturershallestablishandmaintainprocedurestocontrolproductthatdoesnotconformtospecifiedrequirements.Theproceduresshalladdresstheidentification,documentation,evaluation,segregation,anddispositionofnonconformingproduct.Theevaluationofnonconformanceshallincludeadeterminationoftheneedforaninvestigationandnotificationofthepersonsor organizationsresponsibleforthenonconformance.Theevaluationandanyinvestigationshallbedocumented.（a）不合格品的控制。制造商应当建立和维护相应的规程来控制不符合特定要求的产品。该程序应当对不合格品标识、记录、评估、隔离和处理进行规定。对不合格品的评估应当包括明确的调整的需求以及向对不合格品负责的人或组织进行告知。评估和任何的调整都应当予以记录。(b)Nonconformityreviewanddisposition.不合格品的审核和处理(1)Eachmanufacturershallestablishandmaintainproceduresthatdefinetheresponsibilityforreviewandtheauthorityforthedispositionofnonconformingproduct.Theproceduresshallsetforththereviewanddispositionprocess.Dispositionofnonconformingproductshallbedocumented.Documentationshallincludethejustificationforuseofnonconformingproductandthesignatureoftheindividual(s)authorizingtheuse.  （1）制造商应当建立和维护相应规程来界定审核职责以及不合格处理的权限。该程序应当阐明审核和处置过程。不合格品的处置应当予以记录。记录应当包括不合品使用的理由以及批准使用人员的签字。(2)Eachmanufacturershallestablishandmaintainproceduresforrework,toincluderetestingandreevaluationofthenonconformingproductafterrework,toensurethattheproductmeetsitscurrentapprovedspecifications.Reworkandreevaluationactivities,includingadeterminationofanyadverseeffectfromthereworkupontheproduct,shallbedocumentedintheDHR.  （2）制造商应当建立和维护包括在返工后重新对不合格品进行试验和再评估的返工规程来保证重加工产品符合其现行批准的标准。包括确定返工是否给产品带来不利影响的返工和再评估活动应当在记录在DHR中。SubpartJ--CorrectiveandPreventiveAction纠正和预防措施 Sec.820.100Correctiveandpreventiveaction.纠正和预防措施(a)Eachmanufacturershallestablishandmaintainproceduresforimplementingcorrectiveandpreventiveaction.Theproceduresshallincluderequirementsfor:  （a）制造商应当建立和维护用于实施纠正和预防措施的规程。该规程应当包括以下要求：(1)Analyzingprocesses,workoperations,concessions,qualityauditreports,qualityrecords,servicerecords,complaints,returnedproduct,andothersourcesofqualitydatatoidentifyexistingandpotentialcausesofnonconformingproduct,orotherqualityproblems.Appropriatestatisticalmethodologyshallbeemployedwherenecessarytodetectrecurringqualityproblems;  （1）分析工艺、操作、让步接收、质量审计报告、质量记录、服务记录、投诉、返厂产品、其他质量数据的资源来找出存在的和潜在的导致不合格品或其他质量问题的原因。应采用适当的统计技术以发现重复出现的质量问题。(2)Investigatingthecauseofnonconformitiesrelatingtoproduct,processes,andthequalitysystem;  （2）调查与产品、工艺和质量体系相关联的不合格品产生的原因。(3)Identifyingtheaction(s)neededtocorrectandpreventrecurrenceofnonconformingproductandotherqualityproblems;  （3）识别用于纠正和预防不合格品和其他质量问题再发生所需的活动(4)Verifyingorvalidatingthecorrectiveandpreventiveactiontoensurethatsuchactioniseffectiveanddoesnotadverselyaffectthefinisheddevice;  （4）确认和验纠正和预防措施来保证措施有效，并对成品器械不产生不利影响。(5)Implementingandrecordingchangesinmethodsandproceduresneededtocorrectandpreventidentifiedqualityproblems;   （5）实施和记录用于纠正和预防已经确定质量问题方法和程序的变更。(6)Ensuringthatinformationrelatedtoqualityproblemsornonconformingproductisdisseminatedtothosedirectlyresponsibleforassuringthequalityofsuchproductorthepreventionofsuchproblems;and  （6）保证与质量问题或不合格品有关的信息能够传递给那些直接对保证这类产品质量负责的或是能够预防这些问题的人。(7)Submittingrelevantinformationonidentifiedqualityproblems,aswellascorrectiveandpreventiveactions,formanagementreview.  （7）提交已确认的质量问题的相应信息和纠正预防措施进行管理审核。(b)Allactivitiesrequiredunderthissection,andtheirresults,shallbedocumented.  （b）在本节下要求的所有措施、结果都应当予以记录。SubpartK--LabelingandPackagingControl标签和包装控制Sec.820.120Devicelabeling.器械标签Eachmanufacturershallestablishandmaintainprocedurestocontrollabelingactivities.制造商应当建立和维护用于控制标签活动的规程。(a)Labelintegrity.Labelsshallbeprintedandappliedsoastoremainlegibleandaffixedduringthecustomaryconditionsofprocessing,storage,handling,distribution,andwhereappropriateuse.（a）标签的完整性。标签应是打印和印刷的。在其加工、存储、搬运、交付使用的常规条件下应当清晰可辨，粘贴牢固。(b)Labelinginspection.Labelingshallnotbereleasedforstorageoruseuntiladesignatedindividual(s)hasexaminedthelabelingforaccuracyincluding,whereapplicable,thecorrectuniquedeviceidentifier(UDI)oruniversalproductcode(UPC),expirationdate,control number,storageinstructions,handlinginstructions,andanyadditionalprocessinginstructions.Therelease,includingthedateandsignatureoftheindividual(s)performingtheexamination,shallbedocumentedintheDHR.  （b）标签的检验。在标签放行存储或使用前，相应的授权人应对标签进行正确性的检查。包括，适用时，正确的唯一器械标识（UDI）或内部产品代码（UPC）、有效期、控制码、存储条件、运输说明、以及其他的处置要求。包括实施检查人员签字和签署日期的放行措施赢的那个记录在DHR中。(c)Labelingstorage.Eachmanufacturershallstorelabelinginamannerthatprovidesproperidentificationandisdesignedtopreventmixups.  （c）标签存储。制造商应当以一种提供适当标识的方式来存储标签，其目的是防止混淆。(d)Labelingoperations.Eachmanufacturershallcontrollabelingandpackagingoperationstopreventlabelingmixups.Thelabelandlabelingusedforeachproductionunit,lot,orbatchshallbedocumentedintheDHR.  (d)标签的操作。制造商应当控制标签和包装操作来预防标签混淆。用于每个产品单元、批次的标签和标识都应当在DHR中予以记录。(e)Controlnumber.Whereacontrolnumberisrequiredby820.65,thatcontrolnumbershallbeonorshallaccompanythedevicethroughdistribution.（e）控制码。Sec.820.65要求下控制码，在整个销售过程中应始终附着在或伴随着产品。修订历史：[61FR52654,Oct.7,1996,asamendedat78FR55822,Sept.24,2013]Sec.820.130Devicepackaging.器械包装Eachmanufacturershallensurethatdevicepackagingandshippingcontainersaredesignedandconstructedtoprotectthedevicefromalterationordamageduringthecustomary conditionsofprocessing,storage,handling,anddistribution.  制造商应保证设计和构造的器械包装和货运箱能够保护器械在运输加工、存储、搬运、交付使用的常规条件下不发生改变或损坏。SubpartL--Handling,Storage,Distribution,andInstallation搬运、贮存、交付和安装Sec.820.140Handling.搬运Eachmanufacturershallestablishandmaintainprocedurestoensurethatmixups,damage,deterioration,contamination,orotheradverseeffectstoproductdonotoccurduringhandling.  制造商应当建立和维护相应的规程来保证在搬运期间不会发生混淆、损坏、质量下降、污染或其他对产品质量产生的不利影响。Sec.820.150Storage.存储(a)Eachmanufacturershallestablishandmaintainproceduresforthecontrolofstorageareasandstockroomsforproducttopreventmixups,damage,deterioration,contamination,orotheradverseeffectspendinguseordistributionandtoensurethatnoobsolete,rejected,ordeterioratedproductisusedordistributed.Whenthequalityofproductdeterioratesovertime,itshallbestoredinamannertofacilitateproperstockrotation,anditsconditionshallbeassessedasappropriate.  （a）制造商应当建立和维护相应的程序，用于控制产品存储区域和库房，从而预防混淆、损害、质量下降、污染或其他不利影响，保证废品、拒收品、质量下降的产品不被使用和销售。(b)Eachmanufacturershallestablishandmaintainproceduresthatdescribethemethodsforauthorizingreceiptfromanddispatchtostorageareasandstockrooms.（b）制造商应当建立和维护相应的程序，用以描述出入库权限的方法。Sec.820.160Distribution.交付 (a)Eachmanufacturershallestablishandmaintainproceduresforcontrolanddistributionoffinisheddevicestoensurethatonlythosedevicesapprovedforreleasearedistributedandthatpurchaseordersarereviewedtoensurethatambiguitiesanderrorsareresolvedbeforedevicesarereleasedfordistribution.Whereadevice'sfitnessforuseorqualitydeterioratesovertime,theproceduresshallensurethatexpireddevicesordevicesdeterioratedbeyondacceptablefitnessforusearenotdistributed.  （a）制造商应当建立和维护相应的程序用于成品器械的控制和交付来保证只有那些经过批准放行的器械才能被交付，并且采购指令应当经过审核来保证在器械放行销售之前有偏差（不清楚和错误）得以解决。当器械适用和质量跌幅超过期限时，该程序应当保证超期的器械或器械质量下降超过了可接受的适用期时，都不得进行销售。(b)Eachmanufacturershallmaintaindistributionrecordswhichincludeorrefertothelocationof:（b）制造商应当保留销售记录，记录应当涵盖以下内容：(1)Thenameandaddressoftheinitialconsignee;最初销售者的名称和地址(2)Theidentificationandquantityofdevicesshipped;发运设备的标识和数量(3)Thedateshipped;and发运日期；并且(4)Anycontrolnumber(s)used.任何使用的控制码。 Sec.820.170Installation.安装(a)Eachmanufacturerofadevicerequiringinstallationshallestablishandmaintainadequateinstallationandinspectioninstructions,andwhereappropriatetestprocedures.Instructionsandproceduresshallincludedirectionsforensuringproperinstallationsothatthedevicewillperformasintendedafterinstallation.Themanufacturershalldistributetheinstructionsandprocedureswiththedeviceorotherwisemakethemavailabletothe person(s)installingthedevice.  （a）对有安要求的器械，制造商应当建立和维护适当的安装和检测说明书，以及适当的测试规程。安装和规程应包括能够确保设备正确安装的指导，使设备在安装后能够按照预期的要求工作。制造商应当连同器械一起交付说明书和规程或者使安装的器械人员掌握这些规程和说明。(b)Thepersoninstallingthedeviceshallensurethattheinstallation,inspection,andanyrequiredtestingareperformedinaccordancewiththemanufacturer'sinstructionsandproceduresandshalldocumenttheinspectionandanytestresultstodemonstrateproperinstallation.  (b)安装器械的人员应当保证依据制造商说明书和规程实施相应的安装、检测以及任何所需的测试。并记录检测、和任何测试的结果来证明器械得以正确安装。SubpartM--Records记录Sec.820.180Generalrequirements.一般要求AllrecordsrequiredbythispartshallbemaintainedatthemanufacturingestablishmentorotherlocationthatisreasonablyaccessibletoresponsibleofficialsofthemanufacturerandtoemployeesofFDAdesignatedtoperforminspections.Suchrecords,includingthosenotstoredattheinspectedestablishment,shallbemadereadilyavailableforreviewandcopyingbyFDAemployee(s).Suchrecordsshallbelegibleandshallbestoredtominimizedeteriorationandtopreventloss.Thoserecordsstoredinautomateddataprocessingsystemsshallbebackedup.本部分要求的所有记录应当存储于制造企业内部或其他的地方,并且很容易被实施检查的FDA检查员以及制造企业的职责部门合理的调阅。包括不在制造公司存储在内的所有记录应当FDA检查员开放使之能够进行审核和复印。记录应当清洗可辨并且妥善保管以防止丢失或损坏。存储于自动化处理系统的记录应当予以备份。 (a)Confidentiality.RecordsdeemedconfidentialbythemanufacturermaybemarkedtoaidFDAindeterminingwhetherinformationmaybedisclosedunderthepublicinformationregulationinpart20ofthischapter.（a）保密性。制造商应标识认为是保密的记录，以帮助FDA按照本章part20公众信息法规的要求确定其信息是否公开。(b)Recordretentionperiod.Allrecordsrequiredbythispartshallberetainedforaperiodoftimeequivalenttothedesignandexpectedlifeofthedevice,butinnocaselessthan2yearsfromthedateofreleaseforcommercialdistributionbythemanufacturer.（b）记录的保存期限。本部分要求的所有记录都应至少当保存至其器械和设计和预期的有效期，并在制造商放行用于销售器械之日起不少于2年。(c)Exceptions.Thissectiondoesnotapplytothereportsrequiredby820.20(c)Managementreview,820.22Qualityaudits,andsupplierauditreportsusedtomeettherequirementsof820.50(a)Evaluationofsuppliers,contractors,andconsultants,butdoesapplytoproceduresestablishedundertheseprovisions.UponrequestofadesignatedemployeeofFDA,anemployeeinmanagementwithexecutiveresponsibilityshallcertifyinwritingthatthemanagementreviewsandqualityauditsrequiredunderthispart,andsupplierauditswhereapplicable,havebeenperformedanddocumented,thedatesonwhichtheywereperformed,andthatanyrequiredcorrectiveactionhasbeenundertaken.（c）例外。本部分虽然不适用于Sec.820.20（c）所要求的管理评审、Sec.820.22质量审核的报告，同时也不适用于用于满足Sec.820.50（a）供应商（suppliers,contractors,andconsultants）评价的供应商审核报告，但是适用于依据这些规定建立的程序。依据FDA检查员的要求，制造商最高负责人应以书面形式证明，本部分所要求的管理审核、质量审计以及相应的供应商审计活动已经得以实施并予以记录，实施的日期和相应的纠正预防措施应包含记录当中。 Sec.820.181Devicemasterrecord.器械主记录Eachmanufacturershallmaintaindevicemasterrecords(DMR's).EachmanufacturershallensurethateachDMRispreparedandapprovedinaccordancewith820.40.TheDMRforeachtypeofdeviceshallinclude,orrefertothelocationof,thefollowinginformation:制造商应当保存DMR's并保证依据820.40的相关要求提供并批准DRM。每个类型器械的DMR应包括或应涉及的内容，包括以下信息：(a)Devicespecificationsincludingappropriatedrawings,composition,formulation,componentspecifications,andsoftwarespecifications;（a）器械标准，应包括适用的图样、构造、配方、软硬件标准。(b)Productionprocessspecificationsincludingtheappropriateequipmentspecifications,productionmethods,productionprocedures,andproductionenvironmentspecifications;（b）生产工艺标准，包括适用的设备标准、生产方法、生产规程和生产环境标准。(c)Qualityassuranceproceduresandspecificationsincludingacceptancecriteriaandthequalityassuranceequipmenttobeused;（c）质量保证规程和标准，包括接收标准和使用的质量保证设备。(d)Packagingandlabelingspecifications,includingmethodsandprocessesused;and（d）包装和标签标准，包括使用的方法和工艺，并且(e)Installation,maintenance,andservicingproceduresandmethods.（e）安装、维护及服务的规程和方法。Sec.820.184Devicehistoryrecord.器械历史记录Eachmanufacturershallmaintaindevicehistoryrecords(DHR's).EachmanufacturershallestablishandmaintainprocedurestoensurethatDHR'sforeachbatch,lot,orunitaremaintainedtodemonstratethatthedeviceismanufacturedinaccordancewiththeDMRandtherequirementsofthispart.TheDHRshallinclude,orrefertothelocationof,the followinginformation:制造商应当保留DHR's。制造商应当建立和维护相应的程序来保证每批或每个器械的DHR's得以保存，从而证明器械是依据DMR和本部分的要求进行生产的。DHR应包括或应涉及的内容，包括以下信息：(a)Thedatesofmanufacture; 制造日期(b)Thequantitymanufactured;生产数量(c)Thequantityreleasedfordistribution;放行用于销售的数量(d)TheacceptancerecordswhichdemonstratethedeviceismanufacturedinaccordancewiththeDMR;证明器械依据DMR进行生产的检验记录。(e)Theprimaryidentificationlabelandlabelingusedforeachproductionunit;and用于每个生产单元的主要标识标签和标签；并且(f)Anyuniquedeviceidentifier(UDI)oruniversalproductcode(UPC),andanyotherdeviceidentification(s)andcontrolnumber(s)used.使用的UDI或UPC,以及其他器械标识和控制码文件修订历史：[61FR52654,Oct.7,1996,asamendedat78FR55822,Sept.24,2013]Sec.820.186Qualitysystemrecord.质量体系记录Eachmanufacturershallmaintainaqualitysystemrecord(QSR).TheQSRshallinclude,orrefertothelocationof,proceduresandthedocumentationofactivitiesrequiredbythispartthatarenotspecifictoaparticulartypeofdevice(s),including,butnotlimitedto,therecordsrequiredby820.20.EachmanufacturershallensurethattheQSRispreparedandapprovedinaccordancewith820.40.制造商应当保存质量体系记录（QSR）。QSR应包括或应涉及的内容为本部分（不特别限定某一类型器械）所要求的规程话的和文件化的活动，包括但不限于820.20所要求的记录。制造商应当保证依据820.40要求提供并批准QSR。 Sec.820.198Complaintfiles.投诉文档(a)Eachmanufacturershallmaintaincomplaintfiles.Eachmanufacturershallestablishandmaintainproceduresforreceiving,reviewing,andevaluatingcomplaintsbyaformallydesignatedunit.Suchproceduresshallensurethat:（a）制造商应当保留投诉文档。建立和维护一个由指定部门接收、审核、评估投诉的规程。该规程应当保证：(1)Allcomplaintsareprocessedinauniformandtimelymanner;所有投诉都应及时的按既定的程序进行处理。(2)Oralcomplaintsaredocumenteduponreceipt;and口头投诉应当予以记录，并且(3)ComplaintsareevaluatedtodeterminewhetherthecomplaintrepresentsaneventwhichisrequiredtobereportedtoFDAunderpart803ofthischapter,MedicalDeviceReporting.（3）评估投诉来决定该投诉是否为一起事故，并符合本章803部分-《医疗器械报告制度》中向FDA报告的要求，如果是应当向FDA进行报告。(b)Eachmanufacturershallreviewandevaluateallcomplaintstodeterminewhetheraninvestigationisnecessary.Whennoinvestigationismade,themanufacturershallmaintainarecordthatincludesthereasonnoinvestigationwasmadeandthenameoftheindividualresponsibleforthedecisionnottoinvestigate.（b）制造商应当审核和评估所有的投诉来决定是否需要相应的检查。当没有检查时，制造商应当保留不进行检查和以及决定不进行检查决策人的记录。(c)Anycomplaintinvolvingthepossiblefailureofadevice,labeling,orpackagingtomeetanyofitsspecificationsshallbereviewed,evaluated,andinvestigated,unlesssuchinvestigationhasalreadybeenperformedforasimilarcomplaintandanotherinvestigationisnotnecessary. （c）除非有类似的投诉已经进行了相应的检查并且没有必要再进行其他的检查，否则任何可能由器械失效、标签或包装未满足其标准要求的投诉，都应经过必要审核、评估和调查。(d)AnycomplaintthatrepresentsaneventwhichmustbereportedtoFDAunderpart803ofthischaptershallbepromptlyreviewed,evaluated,andinvestigatedbyadesignatedindividual(s)andshallbemaintainedinaseparateportionofthecomplaintfilesorotherwiseclearlyidentified.Inadditiontotheinformationrequiredby820.198(e),recordsofinvestigationunderthisparagraphshallincludeadeterminationof:（d）所有依据本章803部分必须向FDA进行报告的投诉都应由相应的人员进行适当的审核、评估和检查，并且作为投诉文档的一个独立部分被保存下来或通过其他方式进行标识。另外，根据820.198(e)得要求，本部分要求下的检查记录应当包括以下决定：(1)Whetherthedevicefailedtomeetspecifications;器械是偏离标准的要求。(2)Whetherthedevicewasbeingusedfortreatmentordiagnosis;and器械是否用于治疗和诊断，并且(3)Therelationship,ifany,ofthedevicetothereportedincidentoradverseevent.如果有，解释器械与所报告事件或不利影响之间的关系。(e)Whenaninvestigationismadeunderthissection,arecordoftheinvestigationshallbemaintainedbytheformallydesignatedunitidentifiedinparagraph(a)ofthissection.Therecordofinvestigationshallinclude:（e）当按照本节要求进行检查时，检查的记录应当由本节（a）所提及的部门予以保留。检查的记录应当包括以下内容：(1)Thenameofthedevice;器械的名称；(2)Thedatethecomplaintwasreceived;接到投诉的日期；(3)Anyuniquedeviceidentifier(UDI)oruniversalproductcode(UPC),andanyotherdevice identification(s)andcontrolnumber(s)used;使用的UDI或UPC，以及其他器械标识和控制号；(4)Thename,address,andphonenumberofthecomplainant;投诉者的姓名、地址、电话号；(5)Thenatureanddetailsofthecomplaint;投诉的细节和性质；(6)Thedatesandresultsoftheinvestigation;检查的结果和日期；(7)Anycorrectiveactiontaken;and所有纠正措施；并且(8)Anyreplytothecomplainant. 所有投诉的回复。(f)Whenthemanufacturer'sformallydesignatedcomplaintunitislocatedatasiteseparatefromthemanufacturingestablishment,theinvestigatedcomplaint(s)andtherecord(s)ofinvestigationshallbereasonablyaccessibletothemanufacturingestablishment.（f）当制造商规定的接待投诉的部门远离制造单位时，应使制造单位容易的获得经调查的投诉和调查记录。(g)Ifamanufacturer'sformallydesignatedcomplaintunitislocatedoutsideoftheUnitedStates,recordsrequiredbythissectionshallbereasonablyaccessibleintheUnitedStatesateither:（g）如果制造商规定的投诉接待处位于美国本土以外，本节要求的记录应当很容易在美国本土获得。(1)AlocationintheUnitedStateswherethemanufacturer'srecordsareregularlykept;or（1）一个定期保留制造商记录的美国所在地；或(2)Thelocationoftheinitialdistributor.（2）最初的销售所在地。修订历史：[61FR52654,Oct.7,1996,asamendedat69FR11313,Mar.10,2004;71FR16228,Mar. 31,2006;78FR55822,Sept.24,2013]SubpartN--Servicing 服务Sec.820.200Servicing.服务(a)Whereservicingisaspecifiedrequirement,eachmanufacturershallestablishandmaintaininstructionsandproceduresforperformingandverifyingthattheservicingmeetsthespecifiedrequirements.（a）当服务作为一种特定要求时，制造商应当建立和维护用以实施和确认器械符合特定要求的规程和规范。(b)Eachmanufacturershallanalyzeservicereportswithappropriatestatisticalmethodologyinaccordancewith820.100.（b）制造商应依据820.100里的统计方法分析服务报告。(c)EachmanufacturerwhoreceivesaservicereportthatrepresentsaneventwhichmustbereportedtoFDAunderpartofthischaptershallautomaticallyconsiderthereportacomplaintandshallprocessitinaccordancewiththerequirementsof820.198.（c）当制造商接收到一个表现为事故并依据本章节803部分应向FDA报告的服务报告时，制造商应当自动的将该报告作为一个投诉，并按照Sec.820.198的要求进行处理。(d)Servicereportsshallbedocumentedandshallinclude:（d）服务报告应当予以记录，并包括以下内容：(1)Thenameofthedeviceserviced;被服务器械的名称；(2)Anyuniquedeviceidentifier(UDI)oruniversalproductcode(UPC),andanyotherdeviceidentification(s)andcontrolnumber(s)used;(2)使用的UDI或UPC、其他的器械标识和控制码；(3)Thedateofservice;服务的日期； (4)Theindividual(s)servicingthedevice;服务器械的人员；(5)Theserviceperformed;and操作的器械；并且(6)Thetestandinspectiondata.测试和检查的数据。修订说明：[61FR52654,Oct.7,1996,asamendedat69FR11313,Mar.10,2004;78FR55822,Sept.24,2013]SubpartO--StatisticalTechniques统计技术Sec.820.250Statisticaltechniques.统计技术(a)Whereappropriate,eachmanufacturershallestablishandmaintainproceduresforidentifyingvalidstatisticaltechniquesrequiredforestablishing,controlling,andverifyingtheacceptabilityofprocesscapabilityandproductcharacteristics.（a）适用时，制造商应建立和维护用于识别适当的统计技术要求的规程，来确定、控制和确认过程能力和产品特性的可接受性。(b)Samplingplans,whenused,shallbewrittenandbasedonavalidstatisticalrationale.Eachmanufacturershallestablishandmaintainprocedurestoensurethatsamplingmethodsareadequatefortheirintendeduseandtoensurethatwhenchangesoccurthesamplingplansarereviewed.Theseactivitiesshallbedocumented.（b）应制定基于某个适用的统计原理取样计划（如使用）。制造商应建立和维护相应的规程来保证取样的方法满足其预期的用途，并确保取样计划的变更经过审核，所有活动都应当予以记录。Authority:21U.S.C.351,352,360,360c,360d,360e,360h,360i,360j,360l,371,374,381,383;42U.S.C.216,262,263a,264.Source:61FR52654,Oct.7,1996,unlessotherwisenoted.