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Biocompatibility and Performance of Medical Devices 2nd edition [Minkštas viršelis]

Edited by (Biomatech, France)
  • Formatas: Paperback / softback, 586 pages, aukštis x plotis: 229x152 mm, weight: 950 g
  • Serija: Woodhead Publishing Series in Biomaterials
  • Išleidimo metai: 20-Nov-2019
  • Leidėjas: Woodhead Publishing Ltd
  • ISBN-10: 0081026439
  • ISBN-13: 9780081026434
Kitos knygos pagal šią temą:
Biocompatibility and Performance of Medical Devices 2nd editionDidesnis paveikslėlis
  • Formatas: Paperback / softback, 586 pages, aukštis x plotis: 229x152 mm, weight: 950 g
  • Serija: Woodhead Publishing Series in Biomaterials
  • Išleidimo metai: 20-Nov-2019
  • Leidėjas: Woodhead Publishing Ltd
  • ISBN-10: 0081026439
  • ISBN-13: 9780081026434
Kitos knygos pagal šią temą:
Pastovi nuoroda: https://www.kriso.lt/db/9780081026434.html
Raktažodžiai:

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.

  • 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
Contributors xv
Foreword xvii
Introduction xxiii
Part One Introduction to biocompatibility in medical devices 1(46)
1 Strategies to accelerate medical market access and manage risks of biocompatibility
3(14)
R. Eloy
S.J. Goldenberg
1.1 Introduction
3(1)
1.2 Medical device development process and significance of material selection
3(1)
1.3 Accelerating time to market
4(1)
1.4 Concept of biocompatibility and impact on market access
5(3)
1.5 Examples of device recalls or alerts during the last decade in which biocompatibility issues were considered
8(3)
1.6 Challenges in biocompatibility evaluation and novel materials
11(3)
1.7 Conclusion
14(1)
References
15(1)
Further reading
15(2)
2 Making use of a biological safety evaluation plan
17(6)
D. Parente
2.1 Introduction
17(1)
2.2 The fundamentals of safety evaluation planning
17(1)
2.3 Safety evaluation planning for biomaterials
18(1)
2.4 Developing and documenting plans
19(2)
2.5 Using safety evaluations
21(1)
2.6 Conclusion
22(1)
2.7 Sources of further information and advice
22(1)
3 Biomechanical and biochemical compatibility in innovative biomaterials
23(24)
J. Huang
X. Li
Z.X. Guo
3.1 Introduction
23(1)
3.2 Selection of biomaterials
23(2)
3.3 Three generations of biomedical materials
25(1)
3.4 State-of-the-art development
26(8)
3.5 Future trends
34(6)
3.6 Conclusions
40(1)
References
41(5)
Further reading
46(1)
Part Two Evaluation and characterization of biocompatibility in medical devices 47(256)
4 A practical approach to analytical chemistry of medical devices
49(52)
D.E. Albert
4.1 Introduction
49(3)
4.2 The role of analytical chemistry in establishing biocompatibility
52(5)
4.3 Fulfilling the requirements of ISO 10993
57(7)
4.4 Characterization of materials
64(14)
4.5 The changing milieu of E&L testing
78(2)
4.6 Future trends and international approaches
80(4)
4.7 Biocompatibility: To test or not to test
84(1)
4.8 Using chemical and material characterization to demonstrate equivalency
85(3)
4.9 Acceptance criteria for equivalency
88(3)
4.10 Risk assessment of extracts
91(5)
4.11 Conclusion and future trends
96(1)
References
97(4)
5 Tolerable intake values for leachables: Practical use of ISO 10993-17 standard
101(22)
R.R. Brown
5.1 Introduction
101(2)
5.2 Process for setting tolerable intake (TI) values for compounds released from medical device materials
103(4)
5.3 Derivation of non-cancer TI values
107(5)
5.4 Derivation of cancer-based TI values
112(2)
5.5 Use of the TTC approach to derive default non-cancer- and cancer-based TI values
114(1)
5.6 Derivation of TI values for local effects
115(1)
5.7 Other issues to consider
115(3)
5.8 Conclusion
118(1)
References
118(5)
6 In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices
123(44)
W.H. De Jong
J.W. Carraway
R.E. Geertsma
6.1 Introduction
123(2)
6.2 Pretesting considerations
125(5)
6.3 Sample preparation
130(1)
6.4 In vitro testing
131(9)
6.5 In vivo testing
140(19)
6.6 Immunotoxicity (ISO/TS 10993-20:2006)
159(1)
6.7 Nanomaterials (ISO/TR 10993-22:2017)
160(2)
6.8 Conclusion
162(1)
References
162(4)
Further reading
166(1)
7 Practical approach to blood compatibility assessments: General considerations and standards
167(40)
M.F. Wolf
J.M. Anderson
7.1 Introduction
167(1)
7.2 Background: Blood composition
167(7)
7.3 Critical distinguishing factors presented by blood-contacting medical devices
174(6)
7.4 Responses in fluid blood in contact with medical devices
180(5)
7.5 Responses by materials, or upon their surfaces, in contact with blood
185(6)
7.6 Assessing hemocompatibility according to international standards
191(8)
7.7 Conclusion and future trends
199(1)
7.8 Sources of further information and advice
199(1)
References
200(4)
Further reading
204(3)
8 Quality strategies that fasten devices access to global markets
207(16)
J.A. Torfin
S. Gompertz
8.1 Quality management system compliance for medical device development
207(2)
8.2 System-thinking for QMS deployment
209(3)
8.3 Risk-based approach for medical device development
212(1)
8.4 Risk-based QMS elements that add limited value prior to medical device safety testing
213(2)
8.5 Risk-based QMS elements that should he implemented prior to medical device safety testing
215(2)
8.6 Risk-based approach for device testing
217(3)
8.7 Conclusion
220(1)
References
221(2)
9 Accelerating medical device biocompatibility evaluation: An industry perspective
223(40)
K.P. Coleman
W.V. Christian
W. Zhang
9.1 Introduction
223(1)
9.2 Developing a biological evaluation plan
224(2)
9.3 Implementing a biological evaluation plan
226(4)
9.4 Biological safety testing
230(2)
9.5 Creating a biological evaluation report
232(2)
9.6 Special topics
234(6)
9.7 New tools
240(3)
9.8 Conclusion and future trends
243(3)
9.9 Information sources
246(7)
9.10 Appendix
253(4)
References
257(5)
Further reading
262(1)
10 Overcoming negative test results during manufacture
263(6)
D. Parente
10.1 Introduction
263(1)
10.2 Goodbye to cardio medical
264(1)
10.3 The biological safety program
264(1)
10.4 Extractables and leachables
265(1)
10.5 Controlling risk at the manufacturing level
265(1)
10.6 Sterilization residuals
266(1)
10.7 Conclusion
267(2)
11 Methods for the characterization and evaluation of drug-device combination products
269(34)
A.L. Lewis
11.1 Introduction
269(1)
11.2 What is a combination product?
269(1)
11.3 How are combination products regulated?
270(1)
11.4 Demonstrating safety and efficacy of combination products
271(2)
11.5 Pre-clinical testing of combination products
273(19)
11.6 Aspects to consider in the manufacture of combination products
292(3)
11.7 Clinical studies for combination products
295(2)
11.8 Future outlook for combination products and their evaluation
297(1)
References
298(5)
Part Three Testing and interpreting the performance of medical devices 303(108)
12 Efficient evaluations of bone implants performances
305(34)
J.P. Boutrand
12.1 Introduction
305(1)
12.2 Definitions
305(2)
12.3 Scope
307(1)
12.4 Principles for the selection of an in vivo model to evaluate performance of bone implants
307(5)
12.5 Key parameters to accelerate bone devices performance assessment
312(5)
12.6 Selection of comparators
317(1)
12.7 Osteoinductive and osteogenic performances
317(1)
12.8 Limitations of in vitro models
318(2)
12.9 Fracture repair models
320(3)
12.10 Evaluation of medical devices used for spinal fusion
323(2)
12.11 Cylindrical bone defect models
325(1)
12.12 Segmental bone defect repair models
326(1)
12.13 Evaluating the antimicrobial performances of bone repair devices
327(1)
12.14 Bioabsorbable and biodegradable materials
328(1)
12.15 Bone debris and implant performances
329(1)
12.16 Conclusion
330(1)
References
331(6)
Further reading
337(2)
13 Performance studies for dental implants: Methodological approach
339(32)
M. Dard
13.1 Introduction and definitions
339(1)
13.2 Importance of performance evaluation studies for dental implants
340(1)
13.3 Experimental design of a performance trial for dental implants
341(8)
13.4 Choice of model
349(2)
13.5 Statistical power calculation and analysis
351(3)
13.6 Analysis
354(9)
13.7 Translation from animal studies to human clinical trials
363(1)
Sources of further information and advice
364(1)
Acknowledgments
365(1)
References
365(6)
14 Optimizing the design of preclinical safety and performance studies-Examples in soft tissues and cardio-vascular implants
371(22)
E. Drevon-Gaillot
T. Blair
G. Clermont
14.1 Preclinical studies in the device development lifecycle
371(1)
14.2 Preclinical study objectives
372(1)
14.3 Starting point: Use the right documentation to write a strong protocol
373(1)
14.4 Tips to design successful compliant studies
374(12)
14.5 Appropriate evaluation methods and tools to generate robust data
386(3)
14.6 Optimizing the value of your preclinical data and reduce time to market
389(1)
14.7 Conclusion
390(1)
References
391(2)
15 Mechanical testing for soft and hard tissue implants
393(18)
C. Kaddick
15.1 Introduction
393(1)
15.2 Principles of setting up a mechanical test
394(4)
15.3 Implant-specific mechanical performance testing
398(8)
15.4 Advanced therapy products (ATPs)-Cartilage
406(1)
15.5 Conclusion and future trends
406(1)
15.6 Sources of further information and advice
407(1)
References
407(4)
Part Four International regulation of medical devices 411(78)
16 Biological evaluation and regulation of medical devices in the European Union
413(28)
A.T. Keene
16.1 Introduction
413(1)
16.2 The regulatory and legislative framework
413(4)
16.3 General safety and performance requirements
417(12)
16.4 The notified body
429(11)
16.5 Conclusion
440(1)
17 Biological evaluation and regulation of medical devices in Japan
441(34)
K. Kojima
K. Sakaguchi
17.1 Introduction
441(1)
17.2 Outline of biological safety testing in Japan
442(4)
17.3 General requirements for biological safety tests
446(22)
17.4 How to properly use ISO standard, FDA guidance and ASTM standard in Japan
468(1)
17.5 Relationship between classification, examination, and certification in Japan
469(1)
17.6 Outline of the medical device good laboratory practice (GLP)
469(2)
17.7 Conclusion
471(1)
References
472(3)
18 Medical device regulations in China
475(14)
C. Shan
M. Liu
18.1 Introduction
475(1)
18.2 Biological evaluation regulations in China
475(2)
18.3 Outline of biological safety testing in China
477(8)
18.4 Conclusion
485(1)
References
486(2)
Further reading
488(1)
Part Five Histopathology principles for biocompatibility and performance studies 489(56)
19 Current considerations in medical device pathology
491(54)
A. Alves
L. Wancket
A. Metz
19.1 Introduction
491(1)
19.2 Morphologic assessment in the safety studies of biomaterials and medical devices
492(10)
19.3 Assessment of the performance of biomaterials and medical devices
502(7)
19.4 Processing and sectioning of specimens
509(1)
19.5 Staining recommendations
510(3)
19.6 Qualitative and quantitative pathology used in the evaluation of biomaterials and medical devices
513(7)
19.7 Ultrastructural pathology
520(4)
19.8 From digitization to digitalization in medical device pathology
524(1)
19.9 Evaluation of regional draining lymph nodes (RDLs) in non-clinical studies
525(6)
19.10 Morphologic assessment of ocular medical devices
531(6)
19.11 Concluding comments
537(1)
Acknowledgments
538(1)
References
538(7)
Index 545
Jean-Pierre Boutrand is General Manager and Scientific Director for the European division of NAMSA (the world leading medical device evaluation company). Dr Boutrand has been involved in more than 100 public presentations and publications on topics related to medical device evaluation and is registered as an expert on the biological safety of medical devices for ANSM (the French agency for the safety of health products).