Description
Biocompatibility and Performance of Medical Devices (2nd Ed.)
Woodhead Publishing Series in Biomaterials Series
Coordinator: Boutrand Jean-Pierre
Language: EnglishSubjects for Biocompatibility and Performance of Medical Devices:
Keywords
2017/745; 21 CFR 58; 21 CFR 820; 93/42/EEC; Analytical chemistry; Animal model; Animal models; Biocompatibility; Biodegradable; Biointerface; Biological evaluation; Biological evaluation of medical devices; Biological functionality; Biological response; Biological testing; Biomaterials; Blood compatibility; Blood-contacting medical device; Blood-material interactions; Bone; Bone implants; Bone repair; Cardio-vascular and soft tissue implants; Ceramic; Chemical characterization; Combination product regulation; Compliance; Composite; Computational pathology; Conformity assessment; Dental implant; Draining lymph nodes; Drug-device combination products; Extractables; Good Laboratory Practice (GLP); Histopathology of medical devices; Implantable medical devices; In vitro testing; In vivo testing; ISO 10993; ISO 10993 series; ISO 10993-17; ISO 10993-4; ISO 13485; ISO 17025; Leachables; Material and chemical characterization; Medical Device Directive; Medical Device Regulation; Medical devices; Metal; Method; Mixtures; Nanoscale diagnostic systems; Neurosurgical implants; Nonclinical studies; Notified body; Ocular pathology; OECD GLP; Orthopedic research; Osteoconduction; Osteogenesis; Performance; Performance testing; Polymer; Preclinical study; Processing and sectioning of specimens; Quality system; Quality System Regulation; Research and development; Risk assessment; Risk based; Route-to-route extrapolation; Safety; Safety and performance evaluation; Sensitivity; Soft tissues; Study design; Surgical implants; Threshold of toxicological concern (TTC); Tissue engineering templates; Tolerable intake; Toxicological risk assessment; Ultrastructural pathology
586 p. · 15x22.8 cm · Paperback
Description
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Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies.
Part One Introduction to biocompatibility in medical devices 000
1 Strategies to accelerate medical market access and manage risks of biocompatibility R. Eloy and S.J. Goldenberg
2 Making use of a biological safety evaluation plan D. Parente
3 Biomechanical and biochemical compatibility in innovative biomaterials J. Huang, X. Li, and Z.X. Guo
Part Two Evaluation and characterization of biocompatibility in medical devices
4 A practical approach to analytical chemistry of medical devices D.E. Albert
5 Tolerable intake values for leachables: Practical use of ISO 10993-17 standard R.P. Brown
6 In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices W.H. De Jong, J.W. Carraway, and R.E. Geertsma
7 Practical approach to blood compatibility assessments: General considerations and standards M.F. Wolf and J.M. Anderson
8 Quality strategies that fasten devices access to global markets J.A. Torfin and S. Gompertz
9 Accelerating medical device biocompatibility evaluation: An industry perspective K.P. Coleman, W.V. Christian, and W. Zhang
10 Overcoming negative test results during manufacture D. Parente
11 Methods for the characterization and evaluation of drug-device combination products A.L. Lewis
Part Three Testing and interpreting the performance of medical devices
12 Efficient evaluations of bone implants performances J.-P. Boutrand
13 Methods and interpretation of performance studies for dental implants M. Dard
14 Optimizing the design of preclinical safety and performance studies—Examples in soft tissues and cardio-vascular implants E. Drevon-Gaillot, T. Blair, and G. Clermont
15 Mechanical testing for soft and hard tissue implants C. Kaddick
Part Four International regulation of medical devices
16 Biological evaluation and regulation of medical devices in the European Union T. Keene
17 Biological evaluation and regulation of medical devices in Japan K. Kojima and K. Sakaguchi
18 Medical device regulations in China C. Shan and M. Liu
Part Five Histopathology principles for biocompatibility and performance studies
19 Current considerations in medical device pathology A. Alves, L. Wancket, A. Metz
- Presents diverse insights from experts in government, industry and academia
- Delivers a comprehensive overview of testing and interpreting medical device performance
- Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market