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.

All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. - Addresses global regulations and regulatory issues surrounding biomaterials and medical devices - Especially useful for smaller companies who may not employ a full time vigilance professional - Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing

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.

The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes.Following an introduction to the key concepts and challenges involved in sterilisation, the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for 'self-sterilisation' and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices.With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area. - Reviews established and commonly used technologies alongside new and emerging processes - Introduces and reviews the key concepts and challenges involved in sterilisation - Discusses future trends in the sterilisation of biomaterials and medical devices

Metallic Biomaterials Processing and Medical Device Manufacturing details the principles and practices of the technologies used in biomaterials processing and medical device manufacturing. The book reviews the main categories of metallic biomaterials and the essential considerations in design and manufacturing of medical devices. It bridges the gap between the designing of biomaterials and manufacturing of medical devices including requirements and standards. Main themes of the book include, manufacturing, coatings and surface modifications of medical devices, metallic biomaterials and their mechanical behaviour, degradation, testing and characterization, and quality controls, standards and FDA regulations of medical devices. The leading experts in the filed discuss the requirements, challenges, recent progresses and future research directions in the processing of materials and manufacturing of medical devices. Metallic Biomaterials Processing and Medical Device Manufacturing is ideal for those working in the disciplines of materials science, manufacturing, biomedical engineering, and mechanical engineering. - Reviews key topics of biomaterials processing for medical device applications including metallic biomaterials and their mechanical behavior, degradation, testing and characterization - Bridges the gap between biomaterials design and medical device manufacturing - Discusses the quality controls, standards, and FDA requirements for biomaterials and medical devices

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

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

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. - Provides readers with a global perspective on medical device regulations - Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards - Includes a useful case study demonstrating the design and approval process

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

As medical devices become more intricate, with an increasing number of components made from a wide range of materials, it is important that they meet stringent requirements to ensure that they are safe to be implanted and will not be rejected by the human body. Joining and assembly of medical materials and devices provides a comprehensive overview of joining techniques for a range of medical materials and applications.Part one provides an introduction to medical devices and joining methods with further specific chapters on microwelding methods in medical components and the effects of sterilization on medical materials and welded devices. Part two focuses on medical metals and includes chapters on the joining of shape memory alloys, platinum (Pt) alloys and stainless steel wires for implantable medical devices and evaluating the corrosion performance of metal medical device welds. Part three moves on to highlight the joining and assembly of medical plastics and discusses techniques including ultrasonic welding, transmission laser welding and radio frequency (RF)/dielectric welding. Finally, part four discusses the joining and assembly of biomaterial and tissue implants including metal-ceramic joining techniques for orthopaedic applications and tissue adhesives and sealants for surgical applications.Joining and assembly of medical materials and devices is a technical guide for engineers and researchers within the medical industry, professionals requiring an understanding of joining and assembly techniques in a medical setting, and academics interested in this field. - Introduces joining methods in medical applications including microwelding and considers the effects of sterilization on the resulting joints and devices - Considers the joining, assembly and corrosion performance of medical metals including shape memory alloys, platinum alloys and stainless steel wires - Considers the joining and assembly of medical plastics including multiple welding methods, bonding strategies and adhesives