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Titlebook: Safety of Electromedical Devices; Law - Risks - Opport Norbert Leitgeb Book 2010 Springer-Verlag Vienna 2010 Europe.control.design.electrom

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发表于 2025-3-21 19:49:15 | 显示全部楼层 |阅读模式
书目名称Safety of Electromedical Devices
副标题Law - Risks - Opport
编辑Norbert Leitgeb
视频video
概述explains how to introduce a medical device on the European market.discusses legal and technical requirements for manufacturers.presents which safety requirements are to be met and how they can be sati
图书封面Titlebook: Safety of Electromedical Devices; Law - Risks - Opport Norbert Leitgeb Book 2010 Springer-Verlag Vienna 2010 Europe.control.design.electrom
描述Preface Development in the feld of medical technology has resulted in a manifold of medical devices enabling us to diagnose illnesses more reliably, treat them more effciently and compensate for handicaps more effectively. However, these improvements are also - sociated with safety risks. Today, patients are in contact with an increasing number of medical devices longer and more intensively then before. Applied parts are put into contact with the body, probes may be introduced into the body via natural or surgical orifces, and even whole devices may be implanted for many years. The application of devices is no longer restricted to medical locations only. Home use by lay people is increasing and involves even critical devices such as for dialysis, nerve and muscle stimulation and ventilation. In contrast to users’ patients are in a special situation. Their life could depend on the performance of a device, they might be unconscious, may have impaired reactions, or have been made insensitive to pain by medication, and hence they may be exposed to hazards without their awareness and protection by their own reaction. Therefore, medical devices must meet particularly stringent safety req
出版日期Book 2010
关键词Europe; control; design; electromedical devices; environment; hygiene; iron; management; medical devices; ris
版次1
doihttps://doi.org/10.1007/978-3-211-99683-6
isbn_softcover978-3-211-99682-9
isbn_ebook978-3-211-99683-6
copyrightSpringer-Verlag Vienna 2010
The information of publication is updating

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发表于 2025-3-21 22:33:19 | 显示全部楼层
Biocompatibility,Basically, any physical contact of a body with material is associated with diffusion and more or less pronounced exchange of molecules across the contact area. Health risks may occur if health-relevant bioactive substances are delivered to the body. This could have different adverse consequences (.), such as
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Environmental safety,Medical devices may interact with the environment in two different ways: Depending on their kind, construction and function they may be influenced . the environment in many ways as well as having an impact . the environment by adversely influencing or even endangering it.
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https://doi.org/10.1007/978-3-211-99683-6Europe; control; design; electromedical devices; environment; hygiene; iron; management; medical devices; ris
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Application safety,ituations in operating theatres, intensive care units or ambulances), insufficient information (e. g. due to shift changeover), overload (e. g. because of stress, emergency, unexpected events), inattentiveness (e. g. because of distraction or fatigue at the end of a shift).
发表于 2025-3-23 03:36:42 | 显示全部楼层
Electromedical devices, is not mandatory to update devices already in use to meet actual standards. Therefore, for safety assessment of older devices it is helpful to know the historical development of medical safety standards.
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Book 2010reat them more effciently and compensate for handicaps more effectively. However, these improvements are also - sociated with safety risks. Today, patients are in contact with an increasing number of medical devices longer and more intensively then before. Applied parts are put into contact with the
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