Biocompatiblity: Assessment of Medical Devices and Materials
Julian H. Braybrook
Wiley, Aug 4, 1997 - Technology & Engineering - 246 pages
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.
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The Role of Material Standardisation and Method Validation
Biodegradation and Toxicokinetic Studies
The Surface Analysis of Polymeric Biomaterials
7 other sections not shown
absorption activation adsorption analytical animal anticoagulant apoptosis application assay biocompatibility biological evaluation biological hazards biological safety biomaterials biomedical bioprosthesis blood breast implants carcinogenicity cells certified chapter characterisation chemical chlorohydrin clinical coagulation components CRMs cytotoxicity cytotoxicity testing Davies MC degradation products dose effects ethylene oxide evaluation of medical explanted exposure fibrinogen harmonised hazards infection interface ISO/TC laboratories leucocytes macrophages manufacturer materials and devices measurement mechanical medical device Directives medical devices membrane microscopy molecular mutagens patient performance plasma platelet PLGA polymer polyurethane potential procedure prosthesis prosthetic devices protein protocol quantitative Ratner BD relevant requirements residues response risk analysis risk assessment sample significant silicone SIMS specific standard standardised sterile sterilisation sterilisation process structure surface techniques test methods thrombosis thrombus tissue toxicity toxicokinetic toxicokinetic studies toxicological uncertainty validation vascular grafts vitro vivo