- Comprehensive coverage of uses of polymers for medical devices.
- Unique coverage of medical device regulatory aspects, supplier control and process validation.
- Invaluable guide for engineers, scientists and managers involved in the development and marketing of medical devices and materials for use in medical devices.
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. In the new edition Dr. Sastri not only provides a thorough update of the first edition chapters with new information regarding new plastic materials, applications and new requirements, but also adds two chapters – one on market and regulatory aspects and supplier controls, and one on process validation. Both chapters meet an urgent need in the industry and make the book an all-encompassing reference not found anywhere else.
Engineers, scientists, and managers involved in the design and manufacture of medical devices.
Engineers and scientists involved in the tech support for and development and marketing of materials for use in medical device manufacture.
Other professionals involved in the medical device industry, the clinical use of medical devices, and related regulatory and compliance issues.
The medical device supply chain, where Process Validation and Supplier Controls are a requirement.
Plastics in Medical Devices, 2nd Edition
About the Author
1.2 Medical Device Definition
1.3 Types of Devices
1.4 Materials Used in Medical Devices
1.5 Medical Devices—Material Selection Process
1.6 Organization of This Book
2. Regulations for Medical Devices and Application to Plastics Suppliers: History and Overview
2.1 History and Introduction
2.2 United States Regulations
2.3 ISO 13485 (European and Global Standard)
2.4 Other Countries
2.5 Global Harmonization Task Force (GHTF)
2.6 Applicability of the Regulations to Material Suppliers
3. Materials Used in Medical Devices
3.3 Ceramics and Glass
3.5 Why Plastics?
3.6 Types of Plastics
3.7 Homopolymers and Copolymers
3.8 Polymer Blends and Alloys
4. Material Requirements for Plastics Used in Medical Devices
4.2 Material Characterization
4.4 Chemical Resistance
4.6 USP Class VI
4.7 ISO 10993
4.8 Shelf Life and Aging
4.9 Joining and Welding
5. Polymer Additives Used to Enhance Material Properties for Medical Device Applications
5.2 Types of Additives
5.3 Things to Consider When Using Additives
5.5 Wear-Resistant and Lubricious Additives
5.7 Laser Marking
5.8 Radiopaque Additives
5.10 Conductive Fillers
6. Commodity Thermoplastics: Polyvinyl Chloride, Polyolefins, and Polystyrene
6.2 Polyvinyl Chloride (PVC)
6.3 Polyethylene (PE)
6.4 Polypropylene (PP)
6.5 Cyclo Olefin Copolymers (COCs)
6.6 Polystyrene (PS)
6.8 Commodity Thermoplastics Suppliers
7. Engineering Thermoplastics: Acrylics, Polycarbonates, Polyurethanes, Polyacetals, Polyesters, and Polyamides
7.3 Polycarbonates (PCs)
7.4 Polyurethanes (PUs)
7.10 Engineering Thermoplastic Suppliers
8. High-Temperature Engineering Thermoplastics: Polysulfones, Polyimides, Polysulfides, Polyketones, Liquid Crystalline Polymers, and Fluoropolymers
8.2 Polysulfones (PSUs)
8.4 Polyamide-Imides (PAIs)
8.5 Polyphenylene Sulfide (PPS)
8.6 Polyarylether ketones
8.7 Liquid Crystalline Polymers (LCPs)
8.10 High-temperature Engineering Thermoplastics Suppliers
9. Other Polymers: Styrenics, Silicones, Thermoplastic Elastomers, Biopolymers, and Thermosets
9.4 Thermoplastic Elastomers (TPEs)
10. Purchasing Controls and Supplier Quality for Medical Device Manufacturers and Their Suppliers
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
10.5 GHTF Guidance Document on Inspection of Purchasing Controls
11. Process Validation for Medical Device Manufacturers and Their Suppliers
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
11.7 Process Validation Prerequisites
11.8 Process Development and Engineering Studies
11.9 Installation Qualification (IQ)
11.10 Operational Qualification (OQ)
11.11 Performance Qualification (PQ)
11.12 Process Validation Summary Report
11.13 Manual Processes
11.14 Automated Processes and Software Validation
11.15 The Validation Life Cycle