000 06070cam a2200661Ma 4500
001 u380127
003 SIRSI
005 20160812084631.0
006 m o d
007 cr cnu---unuuu
008 131214s2013 vtua ob 001 0 eng d
040 _aEBLCP
_beng
_epn
_cEBLCP
_dOPELS
_dNT
_dUPM
_dCUS
_dOCLCF
_dOCLCQ
_dOCLCO
020 _a9780323265638
_q(electronic bk.)
020 _a0323265634
_q(electronic bk.)
020 _z9781455732012
029 1 _aDEBSZ
_b40535262X
029 1 _aNZ1
_b15351170
029 1 _aNLGGC
_b373104863
050 4 _aR857.P55
_bS27 2014
082 0 4 _a610.28
049 _aTEFA
100 1 _aSastri, Vinod R.,
_d1957-
_eauthor.
245 1 0 _aPlastics in medical devices
_h[recurso electrónico] :
_bproperties, requirements, and applications /
_cVinny Sastri.
250 _a2nd ed.
260 _aBurlington :
_bElsevier Science,
_c[2013]
300 _a1 online resource (xvii, 305 pages) :
_billustrations.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
490 1 _aPlastics Design Library
588 0 _aPrint version record.
520 _aPlastics 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 _aIncludes bibliographical references and index.
505 0 _aMach.
505 0 _aNote 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.
650 0 _aPlastics in medicine.
650 0 _aPlastics.
650 4 _aMedicine.
650 4 _aPlastics in medicine.
650 4 _aPlastics.
650 7 _aHEALTH & FITNESS
_xHolism.
_2bisacsh
650 7 _aHEALTH & FITNESS
_xReference.
_2bisacsh
650 7 _aMEDICAL
_xAlternative Medicine.
_2bisacsh
650 7 _aMEDICAL
_xAtlases.
_2bisacsh
650 7 _aMEDICAL
_xEssays.
_2bisacsh
650 7 _aMEDICAL
_xFamily & General Practice.
_2bisacsh
650 7 _aMEDICAL
_xHolistic Medicine.
_2bisacsh
650 7 _aMEDICAL
_xOsteopathy.
_2bisacsh
650 7 _aPlastics.
_2fast
_0(OCoLC)fst01066542
650 7 _aPlastics in medicine.
_2fast
_0(OCoLC)fst01066659
655 4 _aElectronic books.
776 0 8 _iPrint version:
_aSastri, Vinny R.
_tPlastics in Medical Devices : Properties, Requirements, and Applications.
_dBurlington : Elsevier Science, 2013
_z9781455732012
830 0 _aPlastics Design Library.
856 4 0 _zLibro electrónico
_3ScienceDirect
_uhttp://148.231.10.114:2048/login?url=http://www.sciencedirect.com/science/book/9781455732012
596 _a19
942 _cLIBRO_ELEC
999 _c207048
_d207048