Biocompatiblity: Assessment of Medical Devices and Materials

ISBN-13: 9780471965978 / Angielski / Twarda / 1997 / 248 str.

Julian H. Braybrook;Braybrook; Julian H. Braybrook

Opis

This book presents both an overview and forward assessment of medical device materials and test methods. Highlighting the complex problem of host responses and related issues which may restrict the accuracy and reliability of existing test methodology, the book provides an unbiased appraisal of the requirements for biocompatibility and the approaches that have been developed to evaluate it.

Spis treści

Biocompatibility Standards: An International Overview (D. Marlowe, et al.).

The Role of Material Standardisation and Method Validation in Evaluating Biocompatibility (J. Braybrook).

Biodegradation and Toxicokinetic Studies (D. Gott).

The Surface Analysis of Polymeric Biomaterials (M. Davies, et al.).

Sterilisation Processes and Residuals (V. Dorman–Smith).

Cytotoxicity (M.–F.

Harmand, et al.).

Interactions with Blood (J. Anderson).

Genotoxicity, Carcinogenicity and Reproductive Toxicity (R. Eloy & N. Weill).

Explant Retrieval and Analysis (J. Butany).

Assessment of Biological Safety –
Risk Analysis (J. Tinkler).

Index.

Blurb

The Biomaterials Science and Engineering Series is designed to help stimulate further developments in biomaterials science and engineering by disseminating up–to–the–minute, quality information to academic and industrial research and development scientists employed in all areas of the medical, biomedical and bioengineering sciences whether in medical device R&D, pharmaceutical and pharmacological research or materials science, and to clinical specialists in prosthesis and surgery.

Biocompatibility Assessment of Medical Devices and Materials presents both an overview and forward assessment of medical device materials and test methods. Highlighting the complex problem of host responses and related issues which may restrict the accuracy and reliability of existing test methodology, the book provides an unbiased appraisal of the requirements for biocompatibility and the approaches that have been developed to evaluate it. This much–needed volume specifically addresses:
∗ The rapid development of regulation and standards in the biomedical field over recent years.
∗ The test methods necessary as part of the evaluation of safety of medical materials and devices.
∗ The advantages of standardised, valid analytical measurement, inter– and intra–laboratory testing and certified reference materials.
∗ The problems of surface interaction evaluation, processing techniques and degradation effects.
∗ The application of risk analysis to assessment of biological safety, including the very latest protocols.
In summary, this book provides readers with a comprehensive understanding of the principles involved in the use and interpretation of the current and emerging standards and directives necessary for the evaluation of the biological safety of materials and devices for use in medical applications.