are then selected and must meet the general 'biocompatibility' require ments. Prototypes are built and tested to include biocompatibility evalua tions based on ASTM standard procedures. The device is validated for sterility and freedom from pyrogens before it can be tested on animals or humans. Medical devices are classified as class I, II or III depending on their invasiveness. Class I devices can be marketed by submitting notification to the FDA. Class II and III devices require either that they show equivalence to a device marketed prior to 1976 or that they receive pre-marketing approval. The time from device conception to FDA approval can range from months (class I device) to in excess of ten years (class III device). Therefore, much planning is necessary to pick the best regulatory approach. 2. Wound Dressings and Skin Replacement 2.1 Introduction Wounds to the skin are encountered every day. Minor skin wounds cause some pain, but these wounds will heal by themselves in time. Even though many minor wounds heal effectively without scarring in the absence of treatment, they heal more rapidly if they are kept clean and moist. Devices such as Band-Aids are used to assist in wound healing. For deeper wounds, a variety of wound dressings have been developed including cell cultured artificial skin. These materials are intended to promote healing of skin damaged or removed as a result of skin grafting, ulceration, burns, cancer excision or mechanical trauma.

This book presents an introduction to biomaterials with the focus on the current development and future direction of biomaterials and medical devices research and development in Indonesia. It is the first biomaterials book written by selected academic and clinical experts experts on biomaterials and medical devices from various institutions and industries in Indonesia. It serves as a reference source for researchers starting new projects, for companies developing and marketing products and for governments setting new policies. Chapter one covers the fundamentals of biomaterials, types of biomaterials, their structures and properties and the relationship between them. Chapter two discusses unconventional processing of biomaterials including nano-hybrid organic-inorganic biomaterials. Chapter three addresses biocompatibility issues including in vitro cytotoxicity, genotoxicity, in vitro cell models, biocompatibility data and its related failure. Chapter four describes degradable biomaterial for medical implants, which include biodegradable polymers, biodegradable metals, degradation assessment techniques and future directions. Chapter five focuses on animal models for biomaterial research, ethics, care and use, implantation study and monitoring and studies on medical implants in animals in Indonesia. Chapter six covers biomimetic bioceramics, natural-based biocomposites and the latest research on natural-based biomaterials in Indonesia. Chapter seven describes recent advances in natural biomaterial from human and animal tissue, its processing and applications. Chapter eight discusses orthopedic applications of biomaterials focusing on most common problems in Indonesia, and surgical intervention and implants. Chapter nine describes biomaterials in dentistry and their development in Indonesia.

The current interest in developing novel materials has motivated an increasing need for biological and medical studies in a variety of dinical applications. Indeed, it is dear that to achieve the requisite mechanical, chemical and biomedical properties, especially for new bioactive materials, it is necessary to develop novel synthesis routes. The tremendous success of materials science in developing new biomaterials and fostering technological innovation arises from its focus on interdisciplinary research and collaboration between materials and medical sciences. Materials scientists seek to relate one natural phenomenon to the basic structures of the materials and to recognize the causes and effects of the phenomena. In this way, they have developed explanations for the changing of the properties, the reactions of the materials to the environment, the interface behaviors between the artificial materials and human tissue, the time effects on the materials, and many other natural occurrences. By the same means, medical scientists have also studied the biological and medical effects of these materials, and generated the knowledge needed to produce useful medical devices. The concept of biomaterials is one of the most important ideas ever generated by the application of materials science to the medical field. In traditional materials research, interest focuses primarilyon the synthesis , structure, and mechanical properties of materials commonly used for structural purposes in industry, for instance in mechanical parts of machinery.

Developments in the area of biomaterials, bionanotechnology, tissue engineering, and medical devices are becoming the core of health care. Almost all medical specialties involve the use of biomaterials, and research plays a key role in the development of new and improved treatment modalities. This volume focuses on several current trends in tissue engineering, remodelling and regeneration. Leading researchers describe the use of nanomaterials to create new functionalities when interfaced with biological molecules or structures. In addition to coverage of basic science and engineering aspects, a range of applications in bionanotechnology are presented, including diagnostic devices, contrast agents, analytical tools, physical therapy applications, and vehicles for targeted drug delivery. The use of polymers, alloys, and composites, or a combination of these, for biomaterials applications in orthopaedics is also explored. These contributions represent essential reading for the biomaterials and biomedical engineering communities, and can serve as instructional course lectures targeted at graduate and post-graduate students.

Biomaterials in Translational Medicine delivers timely and detailed information on the latest advances in biomaterials and their role and impact in translational medicine. Key topics addressed include the properties and functions of these materials and how they might be applied for clinical diagnosis and treatment. Particular emphasis is placed on basic fundamentals, biomaterial formulations, design principles, fabrication techniques and transitioning bench-to-bed clinical applications. The book is an essential reference resource for researchers, clinicians, materials scientists, engineers and anyone involved in the future development of innovative biomaterials that drive advancement in translational medicine. - Systematically introduces the fundamental principles, rationales and methodologies of creating or improving biomaterials in the context of translational medicine - Includes the translational or commercialization status of these new biomaterials - Provides the reader with enough background knowledge for a fundamental grip of the difficulties and technicalities of using biomaterial translational medicine - Directs the reader on how to find other up-to-date sources (i.e. peer reviewed journals) in the field of translational medicine and biomaterials

Encyclopedia of Biomedical Engineering, Three Volume Set is a unique source for rapidly evolving updates on topics that are at the interface of the biological sciences and engineering. Biomaterials, biomedical devices and techniques play a significant role in improving the quality of health care in the developed world. The book covers an extensive range of topics related to biomedical engineering, including biomaterials, sensors, medical devices, imaging modalities and imaging processing. In addition, applications of biomedical engineering, advances in cardiology, drug delivery, gene therapy, orthopedics, ophthalmology, sensing and tissue engineering are explored. This important reference work serves many groups working at the interface of the biological sciences and engineering, including engineering students, biological science students, clinicians, and industrial researchers. Provides students with a concise description of the technologies at the interface of the biological sciences and engineering Covers all aspects of biomedical engineering, also incorporating perspectives from experts working within the domains of biomedicine, medical engineering, biology, chemistry, physics, electrical engineering, and more Contains reputable, multidisciplinary content from domain experts Presents a ‘one-stop’ resource for access to information written by world-leading scholars in the field

are then selected and must meet the general 'biocompatibility' require ments. Prototypes are built and tested to include biocompatibility evalua tions based on ASTM standard procedures. The device is validated for sterility and freedom from pyrogens before it can be tested on animals or humans. Medical devices are classified as class I, II or III depending on their invasiveness. Class I devices can be marketed by submitting notification to the FDA. Class II and III devices require either that they show equivalence to a device marketed prior to 1976 or that they receive pre-marketing approval. The time from device conception to FDA approval can range from months (class I device) to in excess of ten years (class III device). Therefore, much planning is necessary to pick the best regulatory approach. 2. Wound Dressings and Skin Replacement 2.1 Introduction Wounds to the skin are encountered every day. Minor skin wounds cause some pain, but these wounds will heal by themselves in time. Even though many minor wounds heal effectively without scarring in the absence of treatment, they heal more rapidly if they are kept clean and moist. Devices such as Band-Aids are used to assist in wound healing. For deeper wounds, a variety of wound dressings have been developed including cell cultured artificial skin. These materials are intended to promote healing of skin damaged or removed as a result of skin grafting, ulceration, burns, cancer excision or mechanical trauma.