| 郑晨,杨鹏飞,刘晓燕.有源医疗器械使用期限评价探讨[J].中国药事,2020,34(8):872-876 |
| 有源医疗器械使用期限评价探讨 |
| On the Lifetime Evaluation of Active Medical Device |
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| DOI：10.16153/j.1002-7777.2020.08.003 |
| 中文关键词: 有源医疗器械 使用期限 技术审评 |
| 英文关键词: active medical device lifetime technical evaluation |
| 基金项目: |
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| 中文摘要: |
| 目的：医疗器械在使用期限内的安全有效至关重要。我国相关医疗器械法规对医疗器械使用期限有明确规定，并出台了相关指导原则。但目前我国有源医疗器械的使用期限研究尚处于起步阶段，尚未形成系统化的标准体系和评价方法。研究符合我国法规要求，适合我国有源医疗器械发展现状的使用期限评价具有重要的现实意义。方法：该文从相关指导原则的制定背景和技术审评的角度出发，探讨有源医疗器械使用期限的定义、适用原则和评价，并加以实例讨论。结果：有源医疗器械使用期限研究应贯穿整个产品生命周期，生产企业应在生产研发过程中，通过风险分析动态考虑产品的使用期限。结论： 科学系统的有源医疗器械使用期限评价研究可以帮助生产企业在研发生产过程中科学开展相关过程，系统完成其产品的使用期限评价，提升产品可靠性，提高注册申报资料质量。 |
| 英文摘要: |
| Objective: The safety and effectiveness of medical devices within the lifetime is vital. Medical device laws and regulations have clear provisions on the lifetime of medical devices in China, and a lifetimeguidance has been issued. However, at present, the study on the lifetime evaluation in an active medical device is still in its infancy, and no systematic standard and evaluation methods have yet been formed. Therefore, it is of great practical significance to study lifetime evaluation in an active medical device in accordance with the requirements of Chinese laws and regulations. Methods: Based on the background of lifetime-guidance and technical evaluation, this article discussed the definition, applicable principles, evaluation methods and examples of lifetime. Results: Lifetime should be studied throughout the whole life cycle of an active medical device. Manufacturers should dynamically consider the lifetime through risk analysis during production, research and development. Conclution: The scientific and systematic study of lifetime evaluation in an active medical device could help manufacturers to scientifically carry out relevant processes during production, research and development, systematically complete the lifetime evaluation for improving reliability of their products, improve product reliability, and improve the quality of registration information of production companies. |
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