• 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.
2 Regulations for Medical Devices and Application to Plastics Suppliers: History and Overview 3 Materials Used in Medical Devices
4 Material Requirements for Plastics used in Medical Devices
5 Polymer Additives Used to Enhance Material Properties for Medical Device
6 Commodity Thermoplastics: Polyvinyl Chloride, Polyolefins, and Polystyrene
7 Engineering Thermoplastics
8 High-Temperature Engineering Thermoplastics: Polysulfones, Polyimides, Polysulfides, Polyketones, Liquid Crystalline Polymers, and Fluoropolymers
9 Other Polymers: Styrenics, Silicones, Thermoplastic Elastomers, Biopolymers, and Thermosets
10 Supplier Controls (new chapter)
11 Process Validation (new chapter)