医疗器械临床评估.doc
《医疗器械临床评估.doc》由会员分享,可在线阅读,更多相关《医疗器械临床评估.doc(5页珍藏版)》请在沃文网上搜索。
1、 Table of Content目录Page页码1.General details总述32.Description of the device and its intended application器械描述和预期用途33. Intended therapeutic and/or diagnostic indications and claims 预期治疗和/或诊断说明和要求34.Context of the evaluation and choice of clinical data types 评估背景和临床数据类型的选择35.Summary of the clinical data a
2、nd appraisal总结临床数据和评价46.Data analysis数据分析56.1.Performance性能56.2.Safety安全56.3.Product Literature and Instructions for Use产品文献和使用说明57.Conclusions结论61. 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 d
3、evice.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 of the manufacturers technical information as appropriate. The description should cover informatio
4、n 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 i
5、ntended 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
6、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State the medical conditions to be treated, including target treatment group and diseases. Outli
7、ne 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 context for the device. The information should include whether the device is based on a new te
8、chnology, 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 technology. Where a completely new technology has been developed, this section would need to give an ov
9、erview of the developmental process and 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 (with appropriate references) could be used. Clearly state if the clinical data used in the eva
10、luation are for an equivalent 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
11、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 features that pose special performance or safety concerns (e.g. presence of medicinal, human or
12、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 clinica
- 1.请仔细阅读文档,确保文档完整性,对于不预览、不比对内容而直接下载带来的问题本站不予受理。
- 2.下载的文档,不会出现我们的网址水印。
- 3、该文档所得收入(下载+内容+预览)归上传者、原创作者;如果您是本文档原作者,请点此认领!既往收益都归您。
下载文档到电脑,查找使用更方便
10 积分
下载 | 加入VIP,下载更划算! |
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- 医疗器械 临床 评估
