ABSTRACT

Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical

chapter 1|10 pages

Safety Evaluation of Medical Devices

chapter 3|28 pages

Road Map to Test Selections

chapter 4|28 pages

Materials in Medical Device Design

chapter 6|12 pages

Cytotoxicity Testing

chapter 7|16 pages

Hemocompatibility (ISO 10993-4)

chapter 8|28 pages

Local Tissue Tolerance

chapter 9|56 pages

Immunotoxicology (ISO 10993-20)

chapter 10|20 pages

Implantation Biology and Studies

chapter 12|50 pages

Genotoxicity

chapter 13|28 pages

5 Introduction

chapter 14|10 pages

Carcinogenicity

chapter 16|16 pages

Special Case Devices

chapter 17|12 pages

Combination Products

chapter 18|20 pages

Clinical Studies for Medical Devices

chapter 21|14 pages

Special Studies

chapter 22|30 pages

Case Histories and Problem Resolution