Reliable design of medical devices / Richard C. Fries.
By: Fries, Richard C
.
Material type: 
BookPublisher: New York : Marcel Dekker, c1997Description: xix, 703 p. : ill. ; 24 cm.ISBN: 0824798430.Subject(s): Medical instruments and apparatus -- Reliability | Medical instruments and apparatus -- Design and construction | Medical instruments and apparatus -- Quality control | Medical instruments and apparatus -- StandardsDDC classification: 681.761 | Item type | Current library | Call number | Copy number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|---|
| General Lending | MTU Bishopstown Library Lending | 681.761 (Browse shelf(Opens below)) | 1 | Available | 00091699 |
Enhanced descriptions from Syndetics:
Presenting the basic concepts and major issues associated with medical device design, this text describes current development processes as well as standards and regulatory information, providing a basis for assessing new technologies. It aims to help manufacturers establish and operate a viable reliability assurance programme, and purchasers to formulate effective methods of vendor evaluation.
Includes bibliographical references and index.
Section 1: Basics of Reliability -- Section 2: Medical Device Regulations and Standards -- Section 3: Specifying and Designing the product -- Section 4: Testing and data analysis -- Section 5: The manufacturing and maintenance process.
Table of contents provided by Syndetics
- Part 1 Basics of reliability: the medical device as an entity
- The concept of failure
- Reliability versus assurance
- Device safety
- Device economics
- Part 2 Medical device regulations and standards: the food and drug administration
- The medical device directives
- ISO 9000 series of standards
- Domestic standards
- International standards
- Part 3 Specifying and designing the product: defining the device
- Requirement engineering
- Risk management
- Liability
- Intellectual property
- Human