Applying a Risk Based Approach to Biological Evaluation of Medical Devices Based on the ISO 10993:18 скачать в хорошем качестве

Applying a Risk Based Approach to Biological Evaluation of Medical Devices Based on the ISO 10993:18

All medical devices that are intended to contact patients or medical personnel (directly or indirectly) require an evaluation of their biocompatibility prior to regulatory submission and market release. The umbrella document for this evaluation is the international standard ISO 10993-1 which includes the framework and thought process for the biological evaluation of medical devices. The potential risks that medical devices carry depend highly on its intended contact type and cumulative duration of use. However, before jumping into testing for the specified biological endpoints identified by Table A.1 in ISO 10993-1, one should consider available information that could provide evidence in support of biological safety and reduce the need for testing. This so-called “risk-based approach” is the heart of the standard and should be applied to any medical device (either being newly submitted for market release or undergoing changes). This presentation will provide an overview of the thought process and flow of medical device biological evaluations (often called a biological evaluation plan or BEP) with an emphasis on the proper application of a risk-based approach.