医疗器械临床评估.doc

CLINICAL EVALUATION REPORT 临床评估报告 For Product: XXXX 产品：XXXX Document No. XXXXXXXX 文件编号 Version: 1.0 版本: Date: 2013-01-28 日期: Author: 作者: Reviewed by: 审阅: Approved by: 批准: Company 公司 Table of Content 目录 Page页码 1. General details总述 3 2. Description of the device and its intended application器械描述和预期用途 3 3. Intended therapeutic and/or diagnostic indications and claims 预期治疗和/或诊断说明和要求 3 4. Context of the evaluation and choice of clinical data types 评估背景和临床数据类型的选择 3 5. Summary of the clinical data and appraisal总结临床数据和评价 4 6. Data analysis数据分析 5 6.1. Performance性能 5 6.2. Safety安全 5 6.3. Product Literature and Instructions for Use产品文献和使用说明 5 7. Conclusions结论 6 General details 总述 State the proprietary name of the device and any code names assigned during device development. Identify the manufacturer(s) 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。 Description of the device and its intended application 器械描述和预期用途 Provide a concise physical description of the device, cross referencing to relevant sections of the manufacturer’s technical information as appropriate. The description should cover information such as: materials, including whether it incorporates a medicinal substance (already on the market or new), tissues, or blood products; the device components, including software and accessories; mechanical characteristics; and others, such as sterile vs. non-sterile, radioactivity etc. State the intended application of the device, single use/reusable; invasive/non invasive; implantable; duration of use or contact with the body; organs, tissues or body fluids contacted by the device. Describe how the device achieves its intended purpose. 对该器械进行简明的物理描述，适当参照生产商技术信息的相关章节。此描述应包含的信息，如： 材料，包括是否含药（已经上市的或全新的）、组织或血液产品； 器械组成，包括软件和附件； 机械特征；和 其他，如灭菌，非灭菌，放射能等等。 描述器械的预期用途，一次性使用/多次使用；侵入/非侵入；可植入；使用持续时间或与人体接触；器械接触的器官，组织或体液。 描述器械如何达到它的预期用途。 Intended therapeutic and/or diagnostic indications and claims预期治疗和/或诊断说明和要求 State the medical conditions to be trea