This collection of peer-reviewed papers presents information on the formulation, design, performance testing, and applications of plastics in medical devices, with an underlying focus on material degradation and failure analysis. Topics include performance requirements, analytical methods, and a myriad of causes and effects of degradation.

The opening chapter of Medical Plastics: Degradation Resistance and Failure Analysis gives an overview of the medical applications of plastics and the specific performance characteristics they require. The following chapters discuss various degrading environments and their effects, including environmental stress cracking, effect of body liquids, effect of harsh environments, and various methods of sterilization. It also discusses the failure of medical devices due to contamination, low temperature, the effects of UV light, migration of formulation components, mechanical stresses, and problems with design and fabrication. Case histories of failures of some common products used in medicine are also provided.

From the Foreword: “...The success of this book will depend upon the reader's appreciation of its combination of an eclectic range of papers which, nevertheless, are unified by the underlying theme: improvement of the performance of medical devices and packages through the understanding of their many modes of failure. Included are both tutorial papers reviewing well established areas of technology and research accounts covering the latest developments in technical areas...It is hoped that this material will be useful. It represents both the long developed state of the medical plastics art and the latest information which can be offered.”

Target Audience: Every reader concerned with the research, design, processing, and use of medical plastics.

Table of Contents:

Overview

Analytical Methods:

Validating Materials for Packaging: Controlling the Front End

Failure Analysis of Polymeric Medical Devices

Materials Analysis Techniques for Medical Devices

Using Burst Testing to Evaluate Sterile Blister Packaging

Servohydraulic Testing Systems for Biomaterials

Measuring Residual Stress in Transparent Plastics

Behavior of Materials:

The Changes in Ethylene Oxide Sterilization and Their Effect on Thermoplastics

Understanding Environmental Stress Cracking in Polyethylene

Failure Morphology of Injection Molded High Density Polyethylene, HDPE, Component with Living Hinge

What Makes Clear Polypropylene Discolor?

Effect of Gamma Radiation on Isothermal Crystallization of Polypropylene

Evaluation of Irradiated Polypropylenes by Strain Rate Dependance of Tensile Properties

Polypropylene Response to High-Energy Radiation

Plastomer Modified Polypropylene Films for Medical Product Packaging

Predicting Post-rad Shelf-life from Accelerated Aging Data: The D&A Process

Chemical Resistance of Polycarbonate

Controlled Ductility Loss of Polycarbonate Through Steam Sterilization

Reprocessing of Medical Vinyl Compounds

Improving the Gamma Resistance of Flexible PVC

Effects of Saline Environment on the Properties of PEEK and Epoxy Composites

The Advantages of Utilizing Thermoplastic Polyesters in Medical Devices Subjected to Harsh Environments

New Polyetherimide Alloy with Engineered Biomedical Properties

Fiber Reinforced Composite Materials for Dental Appliances

Non-Conventional Processing Routes on the Development of Anisotropic and Biodegradable Composites of Starch Based Thermoplastics Reinforced with Bone-Like Ceramics

Assembly of Plastic Parts:

Joining Plastics in Medical Devices: Problems and Solutions

Effective Use of Adhesives in Medical Device Assembly

Packaging Materials:

Correlate Resin Properties to the Cryogenic Impact Performance of Medical Containers

Radiation Sterilization Compatability of Medical Packaging Materials

Light Transmittance of a Thin-Wall Container Made from Isotactic Polypropylene

Index