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Zuverlässiges Design von Medizinprodukten, zweite Auflage-
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Standort: Pomona,CA, USA
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eBay-Artikelnr.:176283349433
Artikelmerkmale
- Artikelzustand
- Actual ISBN
- 9780824723750
- Book Title
- Reliable Design of Medical Devices, Second Edition
- ISBN
- 9780824723750
Über dieses Produkt
Product Identifiers
Publisher
CRC Press LLC
ISBN-10
0824723759
ISBN-13
9780824723750
eBay Product ID (ePID)
45026862
Product Key Features
Number of Pages
504 Pages
Language
English
Publication Name
Reliable Design of Medical Devices
Publication Year
2005
Subject
Materials Science / General, Biotechnology, Instruments & Supplies, Pharmacology
Type
Textbook
Subject Area
Technology & Engineering, Medical
Format
Hardcover
Dimensions
Item Height
1.2 in
Item Weight
30.5 Oz
Item Length
9.6 in
Item Width
6.3 in
Additional Product Features
Edition Number
2
Intended Audience
Scholarly & Professional
LCCN
2005-043942
Dewey Edition
22
Illustrated
Yes
Dewey Decimal
681/.761
Table Of Content
BASICS OF RELIABILITY Reliability The Concept of Failure REGULATIONS AND STANDARDS The Food and Drug Administration The Medical Device Directives Quality System Regulation Domestic Standards International Standards SPECIFYING THE PRODUCT The Medical Device as an Entity Defining the Device Requirements Engineering Safety and Risk Management Liability Intellectual Property DESIGNING THE PRODUCT Six Sigma and Product Design Hardware Design Software Design Software Coding Establishing and Using Metrics Human Factors TESTING AND DATA ANALYSIS The Basis and Types of Testing Hardware Verification and Validation Software Verification and Validation Analysis of Test Results THE MANUFACTURING AND MAINTENANCE PROCESSES GMPs and Manufacturing Configuration Management Analysis of Field Data APPENDICES Appendix 1: Chi Square Table Appendix 2: Percent Rank Tables Appendix 3: Common Failure Modes Appendix 4: Glossary INDEX
Edition Description
Revised edition,New Edition
Synopsis
As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.
LC Classification Number
R856.6.F749 2005
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PassCert4Sure
93,6% positive Bewertungen•99.458 Artikel verkauft
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Verkäuferbewertungen (11.247)
- 8***r (7)- Bewertung vom Käufer.Letzte 6 MonateBestätigter KaufI was searching for this book for a while and was appalled at the cost. I came across this seller and I was happy with the price from the seller. The seller messaged to let me know that this was the global version before it was actually shipped. That, I appreciated so much. My book arrived in perfect condition, looks great. The packaging was secure and the book, brand new. This is of great quality both in the service and the book. I will definitely use this seller again. Excellent!Fundamentals of Human Resource Management 5th Global Edition (Nr. 174750105351)
- i***a (1)- Bewertung vom Käufer.Letzte 6 MonateBestätigter KaufExactly what I ordered, came within the requested delivery date, and in great condition. It was wrapped so well that even though the corner had a very small dent in it, the book inside the package was in perfect condition. For anyone wondering, this seller is LEGIT and offers excellent service.Signals Systems & Transforms 5e Global Edition (Nr. 183193298669)
- *****- Bewertung vom Käufer.Letzter MonatBestätigter KaufGood seller, fast shipping, excellent communication, item as described. Thank you.