基于47 EC法规的基本要求检查表93 42 EEC医疗器械指令.docx
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基于47EC法规的基本要求检查表9342EEC医疗器械指令
基于200747EC法规的基本要求检查表
93/42/EECincluding2007/47/EC
AnnexI
EssentialRequirementsChecklist
93/42/EEC包括2007/47/EC
附录一基本要求检查表
Productname:
Ultrasonicscaler
产品名:
Type(s)/Model(s):
K08
类型/型号
Productgroup:
Ultrasonicscaler;Handpiece;Scalertip;
产品族
IssuedateofTechnical
File:
技术文档发布日:
RevisionofTechnical
File:
技术文档修订版本:
LegalManufacturer:
法定制造商Name名字
Street街道
Postalcode邮编Place地点
Country国家
Accessories:
附件:
Date日期NameReviewer1/审核人1的名字SignatureReviewer1/审核人1签字
Date日期NameReviewer2/审核人2的名字SignatureReviewer2/审核人2签字
ChecklistaccordingtoannexIoftheMedicalDeviceDirective(MDD)
按医疗器械指令(MDD)附录一的基本要求检查表
A/NA
适用/不适用
Standards,otherdirectivesandotherrulesappliedbymanufacturer
制造商引用的标准,其它指令或规则
Documentation(testreports,protocols,literatureorreasonfornoapplicability)
支持性文件(测试报告,方案,文献或不适用的理由)
Requirementsfulfilled(tobefilledinbyNotifiedBody)
要求满足(由公告机构填写)
Ok/
Fail
符合/
不符合
I.
GeneralRequirements
通用要求
1.
Thedevicesmustbedesignedandmanufacturedinsuchawaythat,whenusedundertheconditionsandforthepurposesintended,theywillnotcompromisetheclinicalconditionorthesafetyofpatients,orthesafetyandhealthofusersor,whereapplicable,otherpersons,providedthatanyriskswhichmaybeassociatedwiththeirintendeduseconstituteacceptableriskswhenweighedagainstthebenefitstothepatientandarecompatiblewithahighlevelofprotectionofhealthandsafety.
器械的生产和设计必须保证:
按照其预定用途和条件使用,器械不会损害临床条件、或患者安全、或操作者或其他人员的安全和健康;假设与器械预期用途相关的任何风险,与之给患者带来的益处相比,并与健康安全的保护程度相一致,则是可接受的。
Thisshallinclude:
•reducing,asfaraspossible,theriskofuseerrorduetotheergonomicfeaturesofthedeviceandtheenvironmentinwhichthedeviceisintendedtobeused(designforpatientsafety),and
•considerationofthetechnicalknowledge,experience,educationandtrainingandwhereapplicablethemedicalandphysicalconditionsofintendedusers(designforlay,professional,disabledorotherusers).
应包括:
•尽可能地降低由于器械的人体工学特征和器械预期使用的环境(为患者安全设计的)的错误使用而产生的风险,和
•考虑技术知识、经验、教育和培训,预期用户(为非专业人员、专业人员、伤残人员或其他人)的医疗和身体条件。
ChecklistaccordingtoannexIoftheMedicalDeviceDirective(MDD)
按医疗器械指令(MDD)附录一的基本要求检查表
A/NA适用/不适用
Standards,otherdirectivesandotherrulesappliedbymanufacturer制造商引用的标准,其它指令或规则
Documentation(testreports,protocols,literatureorreasonfornoapplicability)支持性文件(测试报告,方案,文献或不适用的理由)
Requirementsfulfilled(tobefilledinbyNotifiedBody)要求满足(由公告机构填写)
Ok/Fail符合/不符合
2.
Thesolutionsadoptedbythemanufacturerforthedesignandconstructionofthedevicesmustconformtosafetyprinciples,takingaccountofthegenerallyacknowledgedstateoftheart.
Inselectingthemostappropriatesolutions,themanufacturermustapplythefollowingprinciplesinthefollowingorder:
•eliminateorreducerisksasfaraspossible(inherentlysafedesignandconstruction),
•whereappropriatetakeadequateprotectionmeasuresincludingalarmsifnecessary,inrelationtorisksthatcannotbeeliminated,
•Informusersoftheresidualrisksduetoanyshortcomingsoftheprotectionmeasuresadopted.
制造商采用的器械结构和设计方案,必须考虑在当前工艺技术条件下遵守安全原则。
在选择最合适方案时,制造商应按照以下顺序遵守原则:
•尽可能地降低或避免风险
(固有的安全设计和结构)
•对无法避免的风险,如适用,采取适当的防护措施,包括必要的报警。
•告知用户由于所提供防护措施的缺陷而带来的残留风险。
3.
Thedevicesmustachievetheperformancesintendedbythemanufacturerandbedesigned,manufacturedandpackagedinsuchawaythattheyaresuitableforoneormoreofthefunctionsreferredtoinArticle1
(2)(a),asspecifiedbythemanufacturer.
器械最后必须取得制造商期望获得的功能。
器械设计、制造和包装应与第1条
(2)(a)制造商所规定的一项或多项功能相适应。
ChecklistaccordingtoannexIoftheMedicalDeviceDirective(MDD)
按医疗器械指令(MDD)附录一的基本要求检查表
A/NA适用/不适用
Standards,otherdirectivesandotherrulesappliedbymanufacturer制造商引用的标准,其它指令或规则
Documentation(testreports,protocols,literatureorreasonfornoapplicability)支持性文件(测试报告,方案,文献或不适用的理由)
Requirementsfulfilled(tobefilledinbyNotifiedBody)要求满足(由公告机构填写)
Ok/Fail符合/不符合
4.
Thecharacteristicsandperformancesreferredtoinsections1,2and3mustnotbeadverselyaffectedtosuchadegreethattheclinicalconditionandsafetyofthepatientsand,whereapplicable,ofotherpersonsarecompromisedduringthelifetimeofthedeviceasindicatedbythemanufacturer,whenthedeviceissubjectedtothestresseswhichcanoccurduringnormalconditionsofuse.
在制造商确定的器械使用寿命期内,在正常使用可能出现的压力下,第1,2,3款指的各项特征和性能应不能影响临床条件、危害患者或其它人员的安全。
5.
Thedevicesmustbedesigned,manufacturedandpackedinsuchawaythattheircharacteristicsandperformancesduringtheirintendedusewillnotbeadverselyaffectedduringtransportandstoragetakingaccountoftheinstructionsandinformationprovidedbythemanufacturer.
器械设计、生产和包装应当保证器械的特征和性能在运输和储存过程中,只要遵守制造商提供的有关说明和信息,就不会受到重大影响。
6.
Anyundesirablesideeffectsmustconstituteanacceptableriskwhenweighedagainsttheperformancesintended.
副作用的大小同器械的预期性能相比,是可接受的风险。
6a.
DemonstrationofconformitywiththeessentialrequirementsmustincludeaclinicalevaluationinaccordancewithAnnexX.
证明符合基本要求必须包括按照附录X的临床评估
ChecklistaccordingtoannexIoftheMedicalDeviceDirective(MDD)
按医疗器械指令(MDD)附录一的基本要求检查表
A/NA适用/不适用
Standards,otherdirectivesandotherrulesappliedbymanufacturer制造商引用的标准,其它指令或规则
Documentation(testreports,protocols,literatureorreasonfornoapplicability)支持性文件(测试报告,方案,文献或不适用的理由)
Requirementsfulfilled(tobefilledinbyNotifiedBody)要求满足(由公告机构填写)
Ok/Fail符合/不符合
II.
REQUIREMENTSREGARDINGDESIGNANDCONSTRUCTION
设计和结构的要求
7.
Chemical,physicalandbiologicalproperties
化学、物理和生物特征
7.1
ThedevicesmustbedesignedandmanufacturedinsuchawayastoguaranteethecharacteristicsandperformancesreferredtoinSection1onthe"Generalrequirements".Particularattentionmustbepaidto:
•thechoiceofmaterialsused,particularlyasregardstoxicityand,whereappropriateflammability,
•thecompatibilitybetweenthematerialsusedandbiologicaltissues,cellsandbodyfluids,takingaccountoftheintendedpurposeofthedevice.
•Whereappropriate,theresultsofbiophysicalormodellingresearchwhosevalidityhasbeendemonstratedbeforehand.
器械的设计和生产必须保证达到本附录第I部分的通用要求,另外应特别注意:
•合理选择原料,特别是易燃物质和有毒物质的选择;
•从器械预定功能出发考虑所选材料同人体生物组织、细胞和体液的相容性。
•如适用,事先已确认有效的生物物理学或模型研究的结果
7.2
Thedevicesmustbedesigned,manufacturedandpackedinsuchawayastominimisetheriskposedbycontaminantsandresiduestothepersonsinvolvedinthetransport,storageanduseofthedevicesandtothepatients,takingaccountoftheintendedpurposeoftheproduct.Particularattentionmustbepaidtothetissuesexposedandthedurationandfrequencyoftheexposure.
器械的设计、制造和包装应当保证器械在运输、储存和使用过程中的污染和残留物对人体危害最低,应特别注意观察暴露于器械下的人体组织及其时间和频率。
ChecklistaccordingtoannexIoftheMedicalDeviceDirective(MDD)
按医疗器械指令(MDD)附录一的基本要求检查表
A/NA适用/不适用
Standards,otherdirectivesandotherrulesappliedbymanufacturer制造商引用的标准,其它指令或规则
Documentation(testreports,protocols,literatureorreasonfornoapplicability)支持性文件(测试报告,方案,文献或不适用的理由)
Requirementsfulfilled(tobefilledinbyNotifiedBody)要求满足(由公告机构填写)
Ok/Fail符合/不符合
7.3
Thedevicesmustbedesignedandmanufacturedinsuchawaythattheycanbeusedsafelywiththematerials,substancesandgaseswithwhichtheyenterintocontactduringtheirnormaluseorduringroutineprocedures;ifthedevicesareintendedtoadministermedicinalproductstheymustbedesignedandmanufacturedinsuchawayastobecompatiblewiththemedicinalproductsconcernedaccordingtotheprovisionsandrestrictionsgoverningthoseproductsandthattheirperformanceismaintainedinaccordancewiththeintendeduse.
器械设计和生产必须保证在正常使用和常规过程中接触其它材料、物质和气体不会影响其安全使用;如果器械需要加载其它药品,器械的设计和生产必须保证同该药品相兼容,必须考虑法规对该药品的规定和限制,保证器械达到预定功能。
7.4
Whereadeviceincorporates,asanintegralpart,asubstancewhich,ifusedseparately,maybeconsideredtobeamedicinalproductasdefinedinArticle1ofDirective2001/83/ECandwhichisliabletoactuponthebodywithactionancillarytothatofthedevice,thequality,safetyandusefulnessofthesubstancemustbeverifiedbyanalogywiththemethodsspecifiedinAnnexIto
ChecklistaccordingtoannexIoftheMedicalDeviceDirective(MDD)
按医疗器械指令(MDD)附录一的基本要求检查表
A/NA适用/不适用
Standards,otherdirectivesandotherrulesappliedbymanufacturer制造商引用的标准,其它指令或规则
Documentation(testreports,protocols,literatureorreasonfornoapplicability)支持性文件(测试报告,方案,文献或不适用的理由)
Requirementsfulfilled(tobefilledinbyNotifiedBody)要求满足(由公告机构填写)
Ok/Fail符合/不符合
Directive2001/83/EC.
如果某种器械含有某种物质作为其组成部分,而且该物质单独使用时可被认为是2001/83EC第1条含义内的药品,并且它能够帮助该器械对人体产生辅助作用,这种物质的安全性、质量和有效性必须通过2001/83/EC指令附录I涉及的适用方法进行类推来确认。
Forthesubstancesreferredtointhefirstparagraph,thenotifiedbodyshall,havingverifiedtheusefulnessofthesubstanceaspartofthemedicaldeviceandtakingaccountoftheintendedpurposeofthedevice,seekascientificopinionfromoneofthecompetentauthoritiesdesignatedbytheMemberStatesortheEuropeanMedicinesAgency(EMEA)actingparticularlythroughitscommitteeinaccordancewithRegulation(EC)No726/20041onthequalityandsafetyofthesubstanceincludingtheclinicalbenefit/riskprotheincorporationofthesubstanceintothedevice.Whenissuingitsopinion,thecompetentauthorityortheEMEAshalltakeintoaccountthemanufacturingprocessandthedatarelatedtothe