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Biocompatibility and performance of medical devices /

Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe and biocompatible, and that they will perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Boutrand, Jean-Pierre
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Philadelphia, Pa. : Woodhead Pub., 2012.
Colección:Woodhead Publishing series in biomaterials ; no. 50.
Temas:
Acceso en línea:Texto completo

MARC

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245 0 0 |a Biocompatibility and performance of medical devices /  |c edited by Jean-Pierre Boutrand. 
260 |a Philadelphia, Pa. :  |b Woodhead Pub.,  |c 2012. 
300 |a 1 online resource (xxiii, 518 pages) :  |b illustrations. 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
490 1 |a Woodhead Publishing series in biomaterials,  |x 2049-9485 ;  |v no. 50 
504 |a Includes bibliographical references and index. 
505 0 |a pt. 1. Introduction to biocompatibility in medical devices -- pt. 2. Evaluation and characterisation of for biocompatibility in medical devices -- pt. 3. Testing and interpreting the performance of medical devices -- pt. 4. International regulation of medical devices -- pt. 5. Histopathology principles for biocompatibility and performance studies. 
520 |a Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe and biocompatible, and that they will perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices. Part one introduces the key concepts and challenges faced in relation to biocompatibility in medical devices, with consideration of biological safety evaluation planning and biomechanical and biochemical compatibility in innovative biomaterials. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices. Topics covered include material and chemical characterisation, allowable limits for toxic leachables, in vivo and in vitro testing and blood compatibility assessment. Testing and interpreting medical device performance is the focus of part three, with chapters describing preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing of soft and hard tissue implants. Part four provides information on the regulation of medical devices in the European Union, Japan and China, and the book concludes with part five, a review of histopathology principles for biocompatibility and performance studies. With its distinguished editor and international team of expert contributors, Biocompatibility and performance of medical devices is a vital tool for all those involved in the research, design, production and application of medical devices, including research directors, production companies and medical regulatory agencies, as well as industry professionals and academics. Examines the key concepts and challenges faced in relation to biocompatibility in medical devicesDiscusses evaluation and characterisation issues, including material and chemical characterization, allowable limits for toxic leachables, in vivo and in vitro testing, and blood compatibility assessmentDelivers a comprehensive overview of testing and interpreting medical device performance. 
650 0 |a Biomedical materials  |x Biocompatibility. 
650 0 |a Medical instruments and apparatus. 
650 0 |a Biocompatibility. 
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650 6 |a Biomat�eriaux  |0 (CaQQLa)201-0025723  |x Biocompatibilit�e.  |0 (CaQQLa)201-0380733 
650 6 |a M�edecine  |x Appareils et instruments.  |0 (CaQQLa)201-0015728 
650 6 |a Biocompatibilit�e.  |0 (CaQQLa)201-0152769 
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650 7 |a Biomedical materials  |x Biocompatibility  |2 fast  |0 (OCoLC)fst00832587 
650 7 |a Medical instruments and apparatus  |2 fast  |0 (OCoLC)fst01014194 
700 1 |a Boutrand, Jean-Pierre. 
776 0 8 |i Print version:  |t Biocompatibility and performance of medical devices.  |d Philadelphia, Pa. : Woodhead Pub., 2012  |w (DLC) 2012947092 
830 0 |a Woodhead Publishing series in biomaterials ;  |v no. 50.  |x 2049-9485 
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856 4 0 |u https://sciencedirect.uam.elogim.com/science/book/9780857090706  |z Texto completo