Plastics in medical devices : properties, requirements, and applications / Vinny R. Sastri.

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...

Full description

Saved in:

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. HEALTH & FITNESS > Holism. HEALTH & FITNESS > Reference. MEDICAL > Alternative Medicine. MEDICAL > Atlases. MEDICAL > Essays. MEDICAL > Family & General Practice. MEDICAL > Holistic Medicine. MEDICAL > Osteopathy. Plastics Plastics in medicine
Online Access:	Click for online access

Table of Contents:

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.

Plastics in medical devices : properties, requirements, and applications / Vinny R. Sastri.

Similar Items