医疗器械临床评价_中英文翻译

CLINICAL UATION REPORTCLINICAL UATION REPORT 临床评估报告临床评估报告 For Product XXXXFor Product XXXX 产品产品XXXXXXXX Document No.Document No. XXXXXXXXXXXXXXXX 文件编号文件编号 VersionVersion 1.01.0 版本版本 Date 2020-03-04Date 2020-03-04 日期日期 AuthorAuthor 作者作者 Reviewed byReviewed by 审阅审阅 Approved byApproved by 批准批准 CLINICAL UATION REPORT forCLINICAL UATION REPORT for Product XXXXProduct XXXX 临床评估报告临床评估报告 产品产品 Document No. XXXXXXXX 文件编号 Version 1.0 版本 Date 2020-03-04 日期 Table of ContentTable of Content 目录目录 PagePage 页码页码 1.1.General detailsGeneral details 总述总述 3 3 2.2.Description of the device and its intended applicationDescription of the device and its intended application 器械描述和预期用途器械描述和预期用途 3 3 3.3. IntendedIntendedtherapeutictherapeuticand/orand/ordiagnosticdiagnosticindicationsindicationsandandclaimsclaims 预期治疗和预期治疗和/ /或诊断说明和要求或诊断说明和要求 . .3 3 4.4. ContextContextofofthetheuationuationandandchoicechoiceofofclinicalclinicaldatadatatypestypes 评估背景和临床数据类型的选择评估背景和临床数据类型的选择. .3 3 5.5.Summary of the clinical data and appraisalSummary of the clinical data and appraisal 总结临床数据和评价总结临床数据和评价 4 4 6.6.Data analysisData analysis 数据分析数据分析. . 5 5 6.1.6.1.P Peranceerance 性能性能 5 5 6.2.6.2.S Safetyafety 安全安全 . .5 5 6.3.6.3.P Product Literature and Instructions for Useroduct Literature and Instructions for Use 产品文献和使用说明产品文献和使用说明. .5 5 7.7.ConclusionsConclusions 结论结论 6 6 2 2 / / 6Page6Page 页码页码 2 2 ofof 6 6 CLINICAL UATION REPORT forCLINICAL UATION REPORT for Product XXXXProduct XXXX 临床评估报告临床评估报告 产品产品 Document No. XXXXXXXX 文件编号 Version 1.0 版本 Date 2020-03-04 日期 1.1.General detailsGeneral details 总述总述 State the proprietary name of the device and any code names assigned during device development.State the proprietary name of the device and any code names assigned during device development. Identify the manufacturers of the device.Identify the manufacturers of the device. 描述器械的商品名，以及在器械研发过程中使用的任何编码。识别器械的生产商。描述器械的商品名，以及在器械研发过程中使用的任何编码。识别器械的生产商。 2.2.Description of the device and its intended applicationDescription of the device and its intended application 器械描述和预期用途器械描述和预期用途 Provide a concise physical description of the device, cross referencing to relevant sections of theProvide a concise physical description of the device, cross referencing to relevant sections of the manufacturermanufacturer’’ s technical ination as appropriate. The description should cover inations technical ination as appropriate. The description should cover ination such assuch as materials, including whether it incorporates a medicinal substance already on the market or new,materials, including whether it incorporates a medicinal substance already on the market or new, tissues, or blood products;tissues, or blood products; the device components, including software and accessories;the device components, including software and accessories; mechanical characteristics; andmechanical characteristics; and others, such as steril