Plastics in medical devices : properties, requirements, and applications

Plastics in Medical Devices is a comprehensive overview of the main types of plastics used in medical device applications. It focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The r...

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Bibliographic Details
Main Author: Sastri, Vinod R., 1957-
Corporate Author: Plastics Design Library.
Format: eBook
Language: English
Published: Amsterdam : Elsevier/William Andrew, [2014]
Edition: Second edition.
Series: PDL handbook series.
Subjects:
Plastics in medicine.
Plastics.
elektronické knihy
electronic books
ISBN: 0323265634
9780323265638
9781455732012
145573201X
Physical Description: 1 online resource (xvii, 305 pages) : illustrations

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Table of contents

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040 |a YDXCP  |b eng  |e rda  |e pn  |c YDXCP  |d OCLCO  |d OCLCF  |d EBLCP  |d OPELS  |d N$T  |d UPM  |d CUS  |d OCLCQ  |d KNOVL  |d ZCU  |d D6H  |d USU  |d OCLCO  |d ICA  |d OCLCQ  |d LVT  |d MERUC  |d OCLCQ  |d OCLCO  |d OCLCA  |d U3W  |d VTS  |d CEF  |d CHVBK  |d RRP  |d ICG  |d VT2  |d AU@  |d OCLCO  |d OCLCQ  |d WYU  |d OCLCO  |d OCLCA  |d STF  |d DKC  |d OCLCO  |d OCLCQ  |d UX1  |d OCLCQ  |d OCLCA  |d AJS  |d VTU  |d E7B  |d COO  |d COCUF  |d K6U  |d PIFAG  |d FVL  |d CASUM  |d TKN  |d TUHNV  |d OCLCO  |d OCLCQ  |d OCLCO  |d OCLCL 
020 |a 0323265634  |q (electronic bk.) 
020 |a 9780323265638  |q (electronic bk.) 
020 |z 9781455732012 
020 |z 145573201X 
035 |a (OCoLC)899590564  |z (OCoLC)865334409  |z (OCoLC)874161816  |z (OCoLC)1101714593 
100 1 |a Sastri, Vinod R.,  |d 1957- 
245 1 0 |a Plastics in medical devices :  |b properties, requirements, and applications /  |c Vinny R. Sastri. 
250 |a Second edition. 
264 1 |a Amsterdam :  |b Elsevier/William Andrew,  |c [2014] 
300 |a 1 online resource (xvii, 305 pages) :  |b illustrations 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
490 1 |a Plastics Design Library (PDL). PDL handbook series 
504 |a Includes bibliographical references and index. 
505 0 |a Mach. 
505 0 |a Note continued: 9.2.3. Chemical Resistance of Styrenics -- 9.2.4. Sterilization of Styrenics -- 9.2.5. Styrenics Biocompatibility -- 9.2.6. Joining and Welding of Styrenics -- 9.2.7. Styrenics -- Applications -- 9.3. Silicones -- 9.3.1. Silicone Production -- 9.3.2. Properties of Silicones -- 9.3.3. Chemical Resistance of Silicones -- 9.3.4. Sterilization of Silicones -- 9.3.5. Silicone Biocompatibility -- 9.3.6. Joining and Welding of Silicones -- 9.3.7. Silicones -- Applications -- 9.4. Thermoplastic Elastomers (TPEs) -- 9.4.1. Thermoplastic Elastomer Production -- 9.4.2. Thermoplastic Elastomers Properties -- 9.4.3. Chemical Resistance of Thermoplastic Elastomers -- 9.4.4. Sterilization of Thermoplastic Elastomers -- 9.4.5. Thermoplastic Elastomer Biocompatibility -- 9.4.6. Thermoplastic Elastomer Joining and Welding -- 9.4.7. Thermoplastic Elastomers -- Applications -- 9.5. Biopolymers -- 9.5.1. Biopolymer Production -- 9.5.2. Biopolymer Properties -- 9.5.3. Chemical Resistance of Biopolymers -- 9.5.4. Biopolymer Sterilization -- 9.5.5. Biocompatibility of Biopolymers -- 9.5.6. Joining and Welding of Biopolymers -- 9.5.7. Biopolymers -- Applications -- 9.6. Thermosets -- 9.6.1. Thermoset Production -- 9.6.2. Properties of Thermosets -- 9.6.3. Thermosets -- Applications -- 9.7. Conclusion -- 9.8. Suppliers -- References -- 10. Purchasing Controls and Supplier Quality for Medical Device Manufacturers and Their Suppliers -- 10.1. Introduction -- 10.2. Plastics Resin and Processing Suppliers and Purchasing Controls -- 10.3. FDA 21 CFR Part 820 Quality System Regulation and ISO 13485 Standard on Purchasing Controls -- 10.4. Global Harmonization Task Force (GHTF) Guidance Document on Purchasing Controls -- 10.4.1. Planning -- 10.4.2. Selection of Potential Suppliers -- 10.4.3. Supplier Evaluation and Acceptance -- 10.4.4. Finalization of Controls -- 10.4.5. Feedback and Communication -- 10.5. GHTF Guidance Document on Inspection of Purchasing Controls -- 10.6. Conclusion -- References -- 11. Process Validation for Medical Device Manufacturers and Their Suppliers -- 11.1. Introduction -- 11.2. Process Validation and the Applicable Regulations and Standards -- 11.3. Processes That May Be Verified -- 11.4. Processes That Require Validation -- 11.5. Process Validation Overview -- 11.6. Process Validation Planning and the Master Validation Plan -- 11.6.1. The Master Validation Plan (MVP) -- 11.6.2. The Validation Plan -- 11.7. Process Validation Prerequisites -- 11.8. Process Development and Engineering Studies -- 11.8.1. Injection Molded Part Example -- 11.9. Installation Qualification (IQ) -- 11.9.1. Injection Molded Part Example -- 11.10. Operational Qualification (OQ) -- 11.10.1. Injection Molded Part Example -- 11.11. Performance Qualification (PQ) -- 11.11.1. Injection Molded Part Example -- 11.12. Process Validation Summary Report -- 11.12.1. Injection Molded Part Example -- 11.13. Manual Processes -- 11.14. Automated Processes and Software Validation -- 11.15. The Validation Life Cycle -- 11.16. Revalidation -- 11.17. Conclusion -- References. 
506 |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty 
520 |a Plastics in Medical Devices is a comprehensive overview of the main types of plastics used in medical device applications. It focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers, and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. Since the first edition the rate of advancement of materials technology has been constantly increasing. 
590 |a Knovel  |b Knovel (All titles) 
650 0 |a Plastics in medicine. 
650 0 |a Plastics. 
655 7 |a elektronické knihy  |7 fd186907  |2 czenas 
655 9 |a electronic books  |2 eczenas 
710 2 |a Plastics Design Library. 
776 0 8 |i Print version:  |a Sastri, Vinod R., 1957-  |t Plastics in medical devices.  |b Second edition.  |d Amsterdam : Elsevier/William Andrew, [2014]  |z 9781455732012  |z 145573201X  |w (DLC) 2013044211  |w (OCoLC)878098452 
830 0 |a PDL handbook series. 
856 4 0 |u https://proxy.k.utb.cz/login?url=https://app.knovel.com/hotlink/toc/id:kpPMDPRA05/plastics-in-medical?kpromoter=marc  |y Full text 

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