Full Description
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.
Contents
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.
