Safety Evaluation of Medical Devices

Shayne C. Gad (Autor)

Buch | Hardcover

387 Seiten

1997
Crc Press Inc (Verlag)
978-0-8247-9827-7 (ISBN)

Infos

Examines the implications of biological and chemical interactions of medical devices with human tissue. This book offers coverage on the evaluation of safety in specialty devices, medical and surgical supplies, imaging systems, in vitro diagnostics, and health information systems. It discusses preapproval and ongoing test requirements necessary for the development of new products.

Inhalt

Road map to test selections; what to test - sampling and sample preparation; cytotoxicity testing; blood compatibility; irritation and pyrogenicity; immunotoxicology; implantation studies; genotoxicity; subchronic and chronic toxicity; carcinogenicity and reproductive and developmental toxicity; sterility, sterilization and heavy metals; clinical studies for medical devices; special studies and special cases; case histories and problem resolution. Appendix: selected acronyms.

Produkt-Details

• Verlagsort: Bosa Roca
• Sprache: englisch
• Maße: 178 x 254 mm
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Laboratoriumsmedizin
• ISBN-10: 0-8247-9827-9 / 0824798279
• ISBN-13: 978-0-8247-9827-7 / 9780824798277
• Zustand: Neuware