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1、Productname:产品名：Type⑸/Model(s):类型/型号Productgroup:产品族IssuedateofTechnicalFile:技术文档发布日：RevisionofTechnicalFile: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：DateU期NameReviewer1/审核人1的名字SignatureReviewer1/审核人1签字Checklistaccordingtoannex1oftheMedicalDeviceDir
2、ective(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1.Genera
3、lRequirements通用要求1.Thedevicesmustbedesignedandmanufactoredinsuchawaythat,whenusedundertheconditionsandforthepurposesintended,theywillnotcompromisetheclinicalconditionorthesafetyofpatients,orthesafetyandhealthofusersor,whereapplicable,otherpersons,providedthatanyriskswhichmaybeassociatedwiththeirint
4、endeduseconstituteacceptableriskswhenweighedagainstthebenefitstothepatientandarecompatiblewithahighlevelofprotectionofhealthandsafety.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、或患者安金、或操作者或其他人员的安金和健康；假设与器械预期用途相关的任何风险，与Z给患者带來的益处相比，并与健康安全的保护程度相一致，则是可接受的。Thisshallinelude:•reducing,asfaraspossible,theriskofus
5、eerrorduetotheergonomicfeaturesofthedeviceandtheenvironmentinwhichthedeviceisintendedtobeused(designforpatientsafety),and•considerationofthetechnicalknowledge,experience,educationandtrainingandwhereapplicablethemedicalandphysicalconditionsofintendedusers(designforlay,professional,disabledorotheruse
6、rs).应包括:•尽可能地降低由丁•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)的错误使用而产牛的风险,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、伤残人员或莫他人)的医疗和身体Checklistaccordingtoannex1oftheMedicalDeviceDirective(MDD)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,literatureo
7、rreasonfornoapplicability)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/不符合按医疗器械指令（MDD）附录一的基本要求检查表条件。2・Thesolutionsadoptedbythemanufacturerforthedesignandco
