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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...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Autor Corporativo: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Amsterdam :
Elsevier/William Andrew,
[2014]
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| Edición: | Second edition. |
| Colección: | PDL handbook series.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Mach.
- 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.