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 highlights the responsibility of medical device designers and engineers to eliminate sites of failure and to test devices to demonstrate their ultimate safety and efficacy. It also evaluates biomaterials and their properties as related to the design and reliability of medical devices. The principles that are described are readily applicable to the biomaterial scaffolds used for generating tissue-engineered constructs.

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.

本书共有5 章,分别是:生物活性材料、材料的生物适应性、无机玻璃的生物学应用、对于生活工艺学的生物合成材料以及细胞组织工艺学。

Biomaterials: From Molecules to Engineered Tissue gives examples of the application areas of biomaterials involving molecules at one end of the spectrum and finished devices in the other. It covers molecular approaches as well as molecules functional in preparing and modifying biomaterials, medical devices and systems, tissue engineering and artificial organs. Chapters on biomedical informatics and ethics complement the design and production aspects with their contribution in informatics and ethical concerns of biomedical research. This is a reference book for the advanced graduate student eager to learn the biomaterials area and for all researchers working in medicine, pharmacy, engineering and basic sciences in universities, hospitals, and industry involved in biomaterials and biomedical device production.

As biomaterials are used in medical devices, meeting needs in such diverse surgical disciplines as ophthalmology, cardiology, neuromuscular surgery, orthopaedics, dentistry, etc., they must have intimate contact with patient's tissue or body fluids, providing a real physical interface which seriously restricts developments. This book is written for those who would like to advance their knowledge of biomaterials. The subject matter of the book is divided into twelve chapters dealing with the structure and relationship of biological and man-made biomaterials. The application of these materials for various medical devices, and recent developments in tissue engineering, are also discussed.