Reliable Design of Medical Devices - Rilegato

Fries, Richard C.

 
9780824798437: Reliable Design of Medical Devices
Rilegato
ISBN 10: 0824798430 ISBN 13: 9780824798437
Casa editrice: CRC Press, 1997

Sinossi

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.

Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.

Contenuti

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 factors; establishing and using metrics; good laboratory practices; hardware design; software design; software coding. Part 4 Testing and data analysis: the basis and type of testing; hardware verification and validation; software verification and validation; analysis of test results. Part 5 The manufacturing and maintenance process: configuration management; analysis of field data; appendix 1 - chi-square table; appendix 2 - percent rank tables; appendix 3 - addresses of standards and regulatory agencies; appendix 4 - detailed summary of the requirements of ISO 9000; appendix 5 - common failure modes; appendix 6 - glossary.

Product Description

Book by Fries Richard C

Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.

Editore
CRC Press
Data di pubblicazione
1997
Lingua
Inglese
ISBN 10 
0824798430
ISBN 13 
9780824798437
Rilegatura
Copertina rigida
Numero edizione
1
Numero di pagine
728
Contatto del produttore
non disponibile
Persona responsabile
non disponibile

Altre edizioni note dello stesso titolo

9780824723750: Reliable Design of Medical Devices

Edizione in evidenza

ISBN 10:  0824723759 ISBN 13:  9780824723750
Casa editrice: CRC Press, 2005
Rilegato