Quality Evaluation of Medical Devices Using TOC Solid Sample Measurement System

Introduction

Many medical devices such as bone connecting materials, artificial joints, and spinal fixations devices have been developed to respond to diverse needs in medical settings. Safety is critical, as these devices are implanted directly in the human body, and high quality standards are applied to these products. Therefore, as the final quality test in the production process, an efficient method for confirming cleanliness has been required. Because the TOC-L total organic carbon (TOC) analyzer and SSM-5000A solid sample combustion unit utilize direct combustion of solid samples, troublesome extraction work is not necessary, and measurements can be performed with a high recovery rate/sensitivity. In this study, medical devices were prepared as samples, and their cleanliness was verified by measuring the total carbon adhering to the devices by using the above- mentioned system. Products can be checked quickly and easily if any chemicals or detergents used in the production process are remained.

July 26, 2018 GMT