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- (Author)
Corporate Author: Elsevier (firma)
Format: eBook
Language: English
Published: Burlington : Elsevier Science, [2013]
Edition: 2nd ed.
Series: Plastics Design Library.
Subjects:
plasty
polymerní materiály
lékařství
biokompatibilita
biomedicínské inženýrství
plastics
polymer materials
medicine
biocompatibility
biomedical engineering
příručky
elektronické knihy
handbooks, manuals, etc
electronic books
ISBN: 9780323265638
9781455732012
Physical Description: 1 online zdroj (xvii, 305 pages) : illustrations.

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Table of contents

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020 |a 9780323265638  |q (ebook) 
020 |z 9781455732012 
035 |a (OCoLC)865334409 
040 |a EBLCP  |b eng  |e pn  |c EBLCP  |d OPELS  |d N$T  |d UPM  |d CUS  |d OCLCF  |d OCLCQ  |d OCLCO 
072 7 |a 678  |x Průmysl makromolekulárních látek. Gumárenský průmysl. Průmysl plastů  |2 Konspekt  |9 19 
080 |a (0.034.2:08)  |2 MRF 
100 1 |a Sastri, Vinod R.,  |d 1957-  |e author. 
245 1 0 |a Plastics in medical devices  |h [elektronický zdroj] :  |b properties, requirements, and applications /  |c Vinny Sastri. 
250 |a 2nd ed. 
260 |a Burlington :  |b Elsevier Science,  |c [2013] 
300 |a 1 online zdroj (xvii, 305 pages) :  |b illustrations. 
490 1 |a Plastics Design Library 
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. 
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 univerzity 
533 |a Elektronická verze Elsevier 
650 0 7 |a plasty  |7 ph124105  |2 czenas 
650 0 7 |a polymerní materiály  |7 ph330252  |2 czenas 
650 0 7 |a lékařství  |7 ph115195  |2 czenas 
650 0 7 |a biokompatibilita  |7 ph388512  |2 czenas 
650 0 7 |a biomedicínské inženýrství  |7 ph135799  |2 czenas 
650 0 9 |a plastics  |2 eczenas 
650 0 9 |a polymer materials  |2 eczenas 
650 0 9 |a medicine  |2 eczenas 
650 0 9 |a biocompatibility  |2 eczenas 
650 0 9 |a biomedical engineering  |2 eczenas 
655 7 |a příručky  |7 fd133209  |2 czenas 
655 7 |a elektronické knihy  |7 fd186907  |2 czenas 
655 9 |a handbooks, manuals, etc  |2 eczenas 
655 9 |a electronic books  |2 eczenas 
710 2 |a Elsevier (firma)  |7 kn20090615020 
830 0 |a Plastics Design Library. 
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