医疗器械临床评估_中英文翻译Word文档格式.docx

1、 1.0版本:Date: 2020-01-23日期:Author:作 者 : Reviewed by:。审阅:Approved by:批准:公司-可编辑修改 -Table of Content目录Page 页码1. General details 总述42. Description of the device and its intended application器械描述和预期用途43. Intended therapeutic and/or diagnostic indications and claims 预 期治疗和/或诊断说明和要求54. Context of the evaluat

2、ion and choice of clinical data types 评 估 背景和临床数据类型的选择55. Summary of the clinical data and appraisal 总结临床数据和评价76. Data analysis 数据分析86.1. Performance 性能86.2. S afety 安全86.3. Product Literature and Instructions for Use 产品文献和使用说明97.Conclusions 结论.91. General details 总 述State the proprietary name of th

3、e 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。2. 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

4、 of the manufacturers 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; mechan

5、ical characteristics; andothers, 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

6、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。3. Intended therapeutic and/or diagnostic indications and claims预期治疗和/或诊断说明和要求

7、State the medical conditions to be treated, including target treatment group and diseases.Outline any specific safety or performance claims made for the device描述使用时的医学条件，包括目标治疗群体和疾病。概述器械的任何特殊安全或性能要求。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Outline the developmental

8、 context for the device. The information should include whether the device is based on a new technology, a new clinical application of an existing technology, or the result of incremental change of an existing technology.The amount of information will differ according to the history of the technolog

9、y. Where a completely new technology has been developed, this section would need to give an overview of the developmental processand the points in the development cycle at which clinical data have been generated. For long standing technology, a shorter description of the history of the technology （w

10、ith appropriate references） could be used.Clearly state if the clinical data used in the evaluation are for anequivalent device. Identify the equivalent device（s） and provide a justification of the equivalency, cross-referenced to the relevant non-clinical documentation that supports the claim.概述器械的

11、发展历史。内容应包括器械是否基于新技术，是否基于现有技术的新临床应用，或者是现有技术增量变化的结果。根据该技术的历史，信息量将有所不同。如果是一项全新技术 发展起来，本章须概述发展过程和发展周期中产生临床数据的节点。如果是常规技术，须简短 描述该技术的历史（须适当引用）。明确指出，评估中使用的临床数据是否来自等同器械。识 别等同器械，并给出等同的理由，参照相关非临床文献，以支撑观点。State the Essential Requirements relevant to the device in question, in particular, any special design feat

12、ures that pose special performance or safety concerns （e.g. presence of medicinal, human or animal components） that were identified in the device risk management documentation and that required assessment from a clinical perspective.陈述有关讨论的器械的基本要求，特别是，任何导致特殊性能或安全特性（如药，人体或动物组织的使用）的特殊设计已经在器械风险管理文件中被识别

13、过，并从临床的角度进行了必要的 评估。Outline how these considerations were used to choose the types of clinical data used for the evaluation. Where published scientific literature has been used, provide a brief outline of the searching/retrieval process, cross-referenced to the literature search protocol and reports.

14、概述这些需要考虑的因素如何用来选择评估中用到的临床数据的类型。如果引用已出版的科学文献，请简要描述检索/回溯过程，参照文献检索草案和报告。5. Summary of the clinical data and appraisal总结临床数据和评价Provide a tabulation of the clinical data used in the evaluation, categorised according to whether the data address the performance or the safety of the device in question. （Note: many individual data sets will address both safety and performance.） Within each category,order the data according to the importance of their contribution to establishing the safety and performance of the device and in re