Safety evaluation in the development of medical devices and combination products. (©2008)

• Record Type: Book
• Further Information: Note: Shayne C. Gad, Marian G. McCord.
• Other Names: Gad, Shayne C, 1948-; McCord, Marian G; Gad, Shayne C, 1948-
• Contents: Regulatory aspects and strategy in medical device and bio materials safety evaluation -- Road map to test selections -- Materials in medical device design -- What to test : sampling and sample preparation -- Cytotoxicity testing -- Hematocompatibiity -- Local tissue tolerance -- Immunotoxicology -- Implantation biology and studies -- Acute systemic testing device safety evaluation -- Genotoxicity -- Subchronic and chronic toxicity and reproductive and developmental toxicity -- Carcinogenicity -- Degradation products and impurties -- Combination products -- Clinical studies for medical devices -- Special studies -- Toxicokinetics in biomaterial and device safety evaluation -- Case histories and problem resolution.
• Edition: 3rd ed
• Publisher Details: New York : Informa Healthcare
• Publication Date: 2008
• Copyright Date: 2008
• Extent: 1 online resource (viii, 300 pages), illustrations
• Subjects: 610.28/4; Biomedical materials -- Testing; Biomedical materials -- Toxicity testing; Biocompatibility -- Testing; Biocompatible Materials; Materials Testing; Equipment Failure; Equipment Safety; Toxicity Tests; MEDICAL -- Instruments & Supplies; Electronic books
• Languages: English
• ISBNs: 9781439809488; 1439809488
• Related ISBNs: 1420071645; 9781420071641
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.