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 |