£159.38

Springer - Biomaterials, Medical Devices and Tissue Engineering

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Description
Explore the fundamental principles of medical technology with this comprehensive text from Springer. This resource covers the essential processes involved in developing medical devices, from initial material selection to meeting biocompatibility requirements. Readers gain knowledge on building and testing prototypes using ASTM standard procedures to ensure safety and effectiveness. Understanding the regulatory landscape is a major part of this text. It explains the critical validation steps for sterility and freedom from pyrogens required before any testing on animals or humans can occur. The book also provides a clear breakdown of medical device classifications. You will learn how Class I, II, and III devices are categorized based on invasiveness and the specific FDA pathways required for marketing, including notification processes and pre-marketing approval requirements.

Key Features

Covers essential biocompatibility requirements and material selection processes for medical device development.

Explains prototype building and testing methods based on established ASTM standard procedures.

Provides detailed information on validation steps for sterility and ensuring devices are free from pyrogens.

Offers a clear guide to medical device classifications ranging from Class I to Class III based on invasiveness.

Details FDA regulatory pathways including notification for Class I and approval processes for Class II and III devices.

Product Specifications
Brand
Springer
Format
hardcover
ASIN
0412412608
Category
Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions > Biomedical Engineering
Domain
Amazon UK
Release Date
30 November 1993
Listed Since
16 February 2007

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