Essential-Requirements-Checklist-of-the-MDD(07-47-

EssentialRequirementsChecklistoftheMDD(07/47/EC)EssentialRequirementsoftheMDD(07/47/EC)医疗器械指令（07/47/EC）基本要求Applicable(Y/N)适用（是/否）RequirementsStandard所符合的标准要求ManufacturersCompliance/Records制造商符合性文件/记录Ok/Fail符合/不符合I.GENERALREQUIREMENTS基本要求1.Thedevicesmustbedesignedandmanufacturedinsuchawaythat,whenusedundertheconditionsandforthepurposesintended,theywillnotcompromisetheclinicalconditionorthesafetyofpatients,orthesafetyandhealthofusersor,whereapplicable,otherpersons,providedthatanyriskswhichmaybeassociatedwiththeiruseconstituteacceptableriskswhenweighedagainstthebenefitstothepatientandarecompatiblewithahighlevelofprotectionofhealthandsafety.Thisshallinclude:－reducing,asfaraspossible,theriskofuseerrorduetotheergonomicfeaturesofthedeviceandtheenvironmentinwhichthedeviceisintendedtobeused(designforpatientsafety),and－considerationofthetechnicalknowledge,experience,educationandtrainingandwhereapplicablethemedicalandphysicalconditionsofintendedusers(designforlay,professional,disabledorotherusers).必须确保医疗器械的设计和制造在使用时或将被使用时不危害临床状况或不伤害到患者的健康，或使用者或其他人员的健康和安全，在产品使用过程中产生的与患者利益相关的风险应是可接受的且符合高级别的健康安全防护措施。应包括以下内容：—尽可能地降低由于医疗器械的性能特征及其使用时所处的环境（为患者安全所设计）而导致的使用错误风险。—考虑技术知识、经验、教育及培训程度、使用者的医疗条件和物理条件（为非专业人士、专业人士、残疾人士及其它使用者所设计）。EssentialRequirementsChecklistoftheMDD(07/47/EC)EssentialRequirementsoftheMDD(07/47/EC)医疗器械指令（07/47/EC）基本要求Applicable(Y/N)适用（是/否）RequirementsStandard所符合的标准要求ManufacturersCompliance/Records制造商符合性文件/记录Ok/Fail符合/不符合2.Thesolutionsadoptedbythemanufacturerforthedesignandconstructionofthedevicesmustconformtosafetyprinciples,takingaccountofthegenerallyacknowledgedstateoftheart.Inselectingthemostappropriatesolutions,themanufacturermustapplythefollowingprinciplesinthefollowingorder:制造商所采用的医疗器械的设计方法和结构方法必须符合安全准则，符合大众公认的技术声明文件。制造商必须依次采用以下准则以选择最适合的方法：eliminateorreducerisksasfaraspossible(inherentlysafedesignandconstruction),尽可能地消除或降低风险（固有安全设计和结构）whereappropriatetakeadequateprotectionmeasuresincludingalarmsifnecessary,inrelationtorisksthatcannotbeeliminated,有关风险不能被消除时，应采取适当的防护措施，必要时包括安装警报装置。informusersoftheresidualrisksduetoanyshortcomingsoftheprotectionmeasuresadopted.把采取了安全措施后仍然可能存在的风险告知给使用者。3.Thedevicesmustachievetheperformancesintendedbythemanufacturerandbedesigned,manufacturedandpackagedinsuchawaythattheyaresuitableforoneormoreofthefunctionsreferredtoinArticle1(2)(a),asspecifiedbythemanufacturer.制造商所设计的医疗器械必须达到预期的性能，并且其设计、生产和包装必须符合条款1（2）（a），由制造商规定的至少一项功能。EssentialRequirementsChecklistoftheMDD(07/47/EC)EssentialRequirementsoftheMDD(07/47/EC)医疗器械指令（07/47/EC）基本要求Applicable(Y/N)适用（是/否）RequirementsStandard所符合的标准要求ManufacturersCompliance/Records制造商符合性文件/记录Ok/Fail符合/不符合4.Thecharacteristicsandperformancesreferredtoinsections1,2and3mustnotbeadverselyaffectedtosuchadegreethattheclinicalconditionandsafetyofthepatientsand,whereapplicable,ofotherpersonsarecompromisedduringthelifetimeofthedeviceasindicatedbythemanufacturer,whenthedeviceissubjectedtothestresseswhichcanoccurduringnormalconditionsofuse.涉及条款1,2和3的产品的特征和性能在制造商所指明的产品有效期内、在正常使用条件下受到挤压时必须不影响临床状况、患者安全以及其他人员的安全。5.Thedevicesmustbedesigned,manufacturedandpackedinsuchawaythattheircharacteristicsandperformancesduringtheirintendedusewillnotbeadverselyaffectedduringtransportandstoragetakingaccountoftheinstructionsandinformationprovidedbythemanufacturer医疗器械的设计、制造和包装在其预期使用过程中其特性和性能不应受到损害，在按制造商提供的说明书和资料进行运输和储存时要保证其特性和性能的完整性。6.Anyundesirablesideeffectsmustconstituteanacceptableriskwhenweighedagainsttheperformancesintended.6a.DemonstrationofconformitywiththeessentialrequirementsmustincludeaclinicalevaluationinaccordancewithAnnexX.当医疗器械的预期性能受到影响时，任何不良副作用必须是可接受的风险。6a.依据附录X，符合性声明和基本要求中必须含有临床评估。II.REQUIREMENTSREGARDINGDESIGNANDCONSTRUCTION设计和结构要求7.Chemical,physicalandbiologicalproperties化学性能、物理性能和生物性能7.1ThedevicesmustbedesignedandmanufacturedinsuchawayastoguaranteethecharacteristicsandperformancesreferredtoinSection1ontheGeneralrequirements.Particularattentionmustbepaidto:医疗器械的设计和制造必须确保其符合“一般要求”中条款1所描述的特征和性能。应特别注意：EssentialRequirementsChecklistoftheMDD(07/47/EC)EssentialRequirementsoftheMDD(07/47/EC)医疗器械指令（07/47/EC）基本要求Applicable(Y/N)适用（是/否）RequirementsStandard所符合的标准要求ManufacturersCompliance/Records制造商符合性文件/记录Ok/Fail符合/不符合thechoiceofmaterialsused,particularlyasregardstoxicityand,whereappropriateflammability,所用物料的选择，尤其要注意其毒性，必要时还要考虑其可燃性。thecompatibilitybetweenthematerialsusedandbiologicaltissues,cellsandbodyfluids,takingaccountoftheintendedpurposeofthedevice.whereappropriate,theresultsofbiophysicalormodellingresearchwhosevalidityhasbeendemonstratedbeforehand.根据医疗器械的预期用途，确保其所使用的物料与生物组织、细胞和体液之间的兼容性。必要时，生物或模化研究结果的有效性事先应得到验证。7.2Thedevicesmustbedesigned,manufacturedandpackedinsuchawayastominimisetheriskposedbycontaminantsandresiduestothepersonsinvolvedinthetransport,storageanduseofthedevicesandtothepatients,takingaccountoftheintendedpurposeoftheproduct.Particularattentionmustbepaidtothetissuesexposedandthedurationandfrequencyoftheexposure.考虑到医疗器械的预期用途，医疗器械的设计、制造和包装必须使污染物和残余物质对在运输、存储和使用过程中所涉及到的人员和患者所造成的风险降低到最低。尤其要注意暴露组织、持续时间和暴露频率。7.3Thedevicesmustbedesignedandmanufacturedinsuchawaythatt