The ISO 10993 series of standards are used by medical device manufacturers for the evaluation of biological safety, more commonly referred to as biocompatibility.
In the 22 parts of this standard, various biological safety endpoints are described and prescribed for evaluation based on a medical device contact type and duration. An evaluation strategy is developed specific to material, device contact, and contact duration; allowing manufacturers to produce devices that are safe for patient contact or implant.
In this 11 part eLearning module, NAMSA experts will guide you through the process outlined in the standards, discuss the most common sections, tests, strategies, as well as share personal experiences with the evaluation strategy and how to plan project timelines with chemical characterization testing, biological risk assessment, and biological effects and tests. This module addresses 11 of the 22 parts of ISO 10993. Each section contains a narrated video, and an education evaluation quiz. Upon successful completion of each section of this module, attendees receive a completion certificate in their grade book, suitable for printing for human resource training requirements.