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Class 1 devicesCase studies in medic...

Ogrodnik, Peter J.,

Class 1 devicesCase studies in medical devices design /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Class 1 devicesPeter J. Ogrodnik.
其他題名:	Case studies in medical devices design /
其他題名:	Class one devices
作者:	Ogrodnik, Peter J.,
出版者:	Amsterdam :Academic Press,2015.
面頁冊數:	1 online resource :ill. (some col.)
標題:	Medical instruments and apparatusDesign and construction.
電子資源:	https://www.sciencedirect.com/science/book/9780128000281
ISBN:	9780128007969 (electronic bk.)

Class 1 devicesCase studies in medical devices design /
Ogrodnik, Peter J.,

Class 1 devicesCase studies in medical devices design /[electronic resource] :Class one devicesPeter J. Ogrodnik. - Amsterdam :Academic Press,2015. - 1 online resource :ill. (some col.)

Includes bibliographical references.

Introduction --1.

The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik's Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library. Class 1 Devices is a companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA) . This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS.

ISBN: 9780128007969 (electronic bk.)Subjects--Topical Terms:

224901
Medical instruments and apparatus
--Design and construction.Index Terms--Genre/Form:

214472
Electronic books.

LC Class. No.: R856

Dewey Class. No.: 681.761

National Library of Medicine Call No.: 2015 A-780

Class 1 devicesCase studies in medical devices design /
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504 $a Includes bibliographical references.
505 0 0 $g 1. $t Introduction -- $g 1.1. $t Reminder concerning classification -- $g 1.2. $t A reminder concerning the importance of design rigour (or design control) -- $g 1.3. $t A reminder concerning understanding the problem -- $g 1.4. $t A reminder concerning a team/holistic approach -- $g 1.5. $t A reminder concerning costs -- $g 1.6. $t Introduction to the case studies -- $g 1.6.1. $t Comments Concerning the Case Studies -- $g 1.7. $t Hints to enable you to understand the text -- $g 2. $t Classification -- $g 2.1. $t Introduction -- $g 2.1.1. $t Timing -- $g 2.2. $t FDA classification -- $g 2.2.1. $t Keywords -- $g 2.3. $t EU MDD classification -- $g 2.4. $t Your turn -- $g 3. $t Taking the Design from Idea to PDS -- $g 3.1. $t Introduction -- $g 3.2. $t Developing the specification -- $g 3.2.1. $t The Need -- $g 3.2.2. $t The PDS -- $g 3.2.3. $t Customer Section -- $g 3.2.4. $t Regulatory and Statutory Section -- $g 3.2.5. $t Technical Section and Performance Section -- $g 3.2.6. $t Sales Section -- $g 3.2.7. $t Manufacturing Section -- $g 3.2.8. $t Packaging and Transportation Section -- $g 3.2.9. $t Environmental Section -- $g 4. $t Conceptual Phase -- $g 4.1. $t A reminder about space -- $g 4.2. $t The relationship with your product design specification (PDS) -- $g 4.3. $t Solution selection -- $g 4.3.1. $t Initial Screening (optional) -- $g 4.3.2. $t Detailed Selection (Essential) -- $g 4.4. $t Summary -- $g 5. $t Embodiment Phase -- $g 5.1. $t A reminder about this phase -- $g 5.2. $t Initial embodiment -- or first prototype phase -- $g 5.2.1. $t Detailed Drawings and Specifications of Components -- $g 5.2.2. $t Calculations/Simulations Demonstrating Performance and Quality in Design -- $g 5.2.2.1. $t FMEA -- $g 5.2.2.2. $t Optimisation -- $g 5.2.2.3. $t Design for X -- $g 5.2.2.4. $t Validation and Verification -- $g 5.2.2.5. $t Design for Manufacture -- $g 5.3. $t Prototype to final design -- $g 5.3.1. $t Link Between this Stage and the Previous Stage -- $g 5.3.2. $t Detailed Drawings and Specifications -- $g 5.3.2.1. $t A Reminder About Logging Modifications -- $g 5.3.2.2. $t Transition from FMEA to Risk Analysis (RA) -- $g 5.3.2.3. $t Essential Requirements (Especially for EU) -- $g 5.3.2.4. $t Validation, Verification and Clinical Evaluation -- $g 5.3.2.5. $t IFUs, Labelling, Other Instructions and Markings -- $g 5.4. $t Summary -- $g 6. $t The Home Run -- $g 6.1. $t A summary of activity -- $g 6.2. $t The technical file -- $g 6.3. $t A note about manufacturing -- $g 6.4. $t A note about post market surveillance (PMS) -- $g 6.5. $t The final furlong -- $g 6.5.1. $t EU -- $g 6.5.2. $t FDA -- $g 6.6. $t Continual improvement.
520 $a The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik's Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library. Class 1 Devices is a companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA) . This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS.
588 0 $a Online resource; title from PDF title page (EBSCO, viewed December 13, 2014).
650 0 $a Medical instruments and apparatus $x Design and construction. $3 224901
650 2 $a Analytical, Diagnostic and Therapeutic Techniques and Equipment $3 872543
650 2 $a Investigative Techniques $3 872544
650 2 $a Equipment Design. $3 302544
650 2 $a Equipment and Supplies. $3 243791
650 1 2 $a Equipment Design $x methods. $3 743619
655 4 $a Electronic books. $2 local. $3 214472
856 4 0 $u https://www.sciencedirect.com/science/book/9780128000281