生物医学设备和传感器
Monitoring the human body is a key element of digital health science. Low-cost sensors derived from smartphones or smartwatches may give the impression that sensors are readily available; however, to date, very few of them are actually medical devices.
Designing medical devices requires us to undertake a specific approach demanding special skills, as it concerns the integrity of the human body. The process is tightly framed by state regulations in order to ensure compliance with quality assessment, risk management and medical ethics requirements.
This book aims to give biomedical students an overview on medical devices design. It firstly gives a historical and economical approach, then develops key elements in medical device design with reference to EU and US regulations, and finally describes sensors for the human body. The clinical approach is presented as the central element in medical device qualification and this offers a perspective on the use of numerical simulation, particularly since its continued growth in the USA; despite the fact that the approach is strictly limited by regulations.
中文|2024 |亚洲：B0DG6QR7YG | 702页| PDF，真EPUB | 19.84 MB 监测人体是数字健康科学的一个关键要素。来自智能手机或智能手表的低成本传感器可能会给人一种传感器很容易获得的印象；然而，迄今为止，它们中很少有是真正的医疗器械。 设计医疗器械需要我们采取一种需要特殊技能的特定方法，因为它关系到人体的完整性。该过程受到国家法规的严格约束，以确保符合质量评估、风险管理和医德要求。 本书旨在为生物医学专业的学生提供医疗器械设计的概述。它首先给出了一种历史和经济的方法，然后参考欧盟和美国的法规开发了医疗器械设计中的关键要素，最后描述了人体传感器。临床方法被视为医疗器械资格认证的核心要素，这为数值模拟的使用提供了一个视角，特别是因为它在美国持续增长；尽管这种方法受到法规的严格限制。本站不对文件进行储存，仅提供文件链接，请自行下载，本站不对文件内容负责，请自行判断文件是否安全，如发现文件有侵权行为，请联系管理员删除。
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