Chapter 15 - Biological evaluation report

Abstract

The primary purpose of the biological evaluation report is to ensure health and safety of both patients and healthcare professionals from a biological and toxicological perspective. In the era of medical devices innovation, a variety of materials have been incorporated to reduce the component size and increase durability. However, a material suitable based on its physical property, availability, and cost might contain toxic components that pose potential health hazards in patients and other users. The EN ISO 10993-1, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk management Process” is a general standard framework/guideline for planning and execution of biological evaluation process to assess the potential risks and safety of a medical device. The extent of device/material characterization depends on number of factors including intended clinical use, duration/nature of body contact, and the existing knowledge on material safety and toxicological data. This chapter outlines the systematic approach for the assessment of biological safety of medical devices.