Safety of Electromedical Devices [recurso electrónico] : Law — Risks — Opportunities / by Norbert Leitgeb.
Tipo de material: TextoEditor: Vienna : Springer Vienna, 2010Descripción: XI, 233 p. online resourceTipo de contenido: text Tipo de medio: computer Tipo de portador: online resourceISBN: 9783211996836Tema(s): Engineering | Biomedical engineering | Engineering | Biomedical EngineeringFormatos físicos adicionales: Printed edition:: Sin títuloClasificación CDD: 610.28 Clasificación LoC:R856-857Recursos en línea: Libro electrónicoTipo de ítem | Biblioteca actual | Colección | Signatura | Copia número | Estado | Fecha de vencimiento | Código de barras |
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Libro Electrónico | Biblioteca Electrónica | Colección de Libros Electrónicos | R856 -857 (Browse shelf(Abre debajo)) | 1 | No para préstamo | 373099-2001 |
Medical devices -- How safe is safe enough? -- Application safety -- Biocompatibility -- Hygiene -- Environmental safety -- Ecological safety -- Electric safety -- Electromedical devices -- Safety testing.
The book discusses the legal and technical requirements for manufacturers, designers and testers of electromedical devices. It describes which obstacles must be overcome to introduce a medical device on the European market, but also informs readers as to pitfalls and opportunities, and in which way safety can be achieved and product liability limited. It explains how the newly required risk management process, which comprises risk analysis, risk assessment, risk management and risk control, can be implemented. As a final essential consideration, the book describes which safety requirements are to be met and how they can be satisfied and tested.
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