biomedical设备和传感器

English | 2024 | ASIN: ‎ B0DG6QR7YG | 702 pages | PDF, True EPUB | 19.84 MB

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.

监测人体是数字健康科学的关键要素。尽管来自智能手机或智能手表的低成本传感器可能会给人感觉传感器已经唾手可得，但到目前为止，实际的医疗设备寥寥无几。 设计医疗设备要求我们必须采取一种特定的方法，并涉及特殊技能，因为它关系到人类的身体完整性。这一过程受国家法规严格框架约束，以确保符合质量评估、风险管理和医学伦理的要求。 这本书旨在为生物医学学生提供关于医疗设备设计的一览概貌。它首先介绍历史和经济的角度，然后根据欧盟和美国的法规发展医疗设备设计的关键要素，并最后描述人体用传感器。临床方法被呈现为医疗设备认证的核心要素，这为使用数值模拟提供了视角——尽管这种方法仍受到严格法规的限制，尤其是在美国。

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