LEADER 04936nam 2200613 450 001 9910824254203321 005 20200520144314.0 010 $a0-12-800796-6 035 $a(CKB)2670000000578338 035 $a(EBL)1882921 035 $a(SSID)ssj0001409266 035 $a(PQKBManifestationID)11755214 035 $a(PQKBTitleCode)TC0001409266 035 $a(PQKBWorkID)11359950 035 $a(PQKB)10444812 035 $a(CaSebORM)9780128000281 035 $a(Au-PeEL)EBL1882921 035 $a(CaPaEBR)ebr10992109 035 $a(CaONFJC)MIL665386 035 $a(OCoLC)903403740 035 $a(MiAaPQ)EBC1882921 035 $a(EXLCZ)992670000000578338 100 $a20141209h20152015 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aClass 1 devices $ecase studies in medical devices design /$fPeter J. Ogrodnik 205 $a1st edition 210 1$aLondon, [England] ;$aSan Diego, California :$cAcademic Press,$d2015. 210 4$dİ2015 215 $a1 online resource (115 p.) 300 $aDescription based upon print version of record. 311 $a0-12-800028-7 311 $a1-322-34104-4 320 $aIncludes bibliographical references. 327 $aCover; Title Page; Copyright Page; Dedication; Contents; Acknowledgements; Chapter 1 - Introduction; 1.1 - Reminder concerning classification; 1.2 - A reminder concerning the importance of design rigour (or design control); 1.3 - A reminder concerning understanding the problem; 1.4 - A reminder concerning a team/holistic approach; 1.5 - A reminder concerning costs; 1.6 - Introduction to the case studies; Case Study: The OTC Joint Support; Case Study: Surgical Wire Cutters; Case Study: Orthopaedic Cast; 1.6.1 - Comments Concerning the Case Studies 327 $a1.7 - Hints to enable you to understand the textChapter 2 - Classification; 2.1 - Introduction; 2.1.1 - Timing; 2.2 - FDA classification; 2.2.1 - Keywords; 2.3 - EU MDD classification; 2.4 - Your turn; Chapter 3 - Taking the Design from Idea to PDS; 3.1 - Introduction; 3.2 - Developing the specification; 3.2.1 - The Need; 3.2.2 - The PDS; 3.2.3 - Customer Section; 3.2.4 - Regulatory and Statutory Section; 3.2.5 - Technical Section and Performance Section; 3.2.6 - Sales Section; 3.2.7 - Manufacturing Section; 3.2.8 - Packaging and Transportation Section; 3.2.9 - Environmental Section 327 $aChapter 4 - Conceptual Phase4.1 - A reminder about space; 4.2 - The relationship with your product design specification (PDS); 4.3 - Solution selection; 4.3.1 - Initial Screening (optional); 4.3.2 - Detailed Selection (Essential); 4.4 - Summary; Chapter 5 - Embodiment Phase; 5.1 - A reminder about this phase; 5.2 - Initial embodiment - or first prototype phase; 5.2.1 - Detailed Drawings and Specifications of Components; 5.2.2 - Calculations/Simulations Demonstrating Performance and Quality in Design; 5.2.2.1 - FMEA; 5.2.2.2 - Optimisation; 5.2.2.3 - Design for X 327 $a5.2.2.4 - Validation and Verification5.2.2.5 - Design for Manufacture; 5.3 - Prototype to final design; 5.3.1 - Link Between this Stage and the Previous Stage; 5.3.2 - Detailed Drawings and Specifications; 5.3.2.1 - A Reminder About Logging Modifications; 5.3.2.2 - Transition from FMEA to Risk Analysis (RA); 5.3.2.3 - Essential Requirements (Especially for EU); 5.3.2.4 - Validation, Verification and Clinical Evaluation; 5.3.2.5 - IFUs, Labelling, Other Instructions and Markings; 5.4 - Summary; Chapter 6 - The Home Run; 6.1 - A summary of activity; 6.2 - The technical file 327 $a6.3 - A note about manufacturing6.4 - A note about post market surveillance (PMS); 6.5 - The final furlong; 6.5.1 - EU; 6.5.2 - FDA; 6.6 - Continual improvement; References; I - Essential Requirements; I - General requirements; II - Requirements regarding design and construction 330 $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 com 606 $aMedical instruments and apparatus$xDesign and construction$vCase studies 615 0$aMedical instruments and apparatus$xDesign and construction 676 $a681.761 700 $aOgrodnik$b Peter J. $0865159 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910824254203321 996 $aClass 1 devices$94101999 997 $aUNINA