Join us for a deep dive into the world of biocompatibility assessment with our three-part webinar series: Navigating ISO 10993: A Comprehensive Guide to Biocompatibility in Medical Devices

Overview

The ISO 10993 series mandates that the chemical constituents profiled from medical devices should undergo a toxicological risk assessment (TRA) to determine any potential human health risks associated with the tested device.

As science and regulatory requirements evolve, TRA has become increasingly important.

The latest edition, published in 2023, titled “Biological Evaluation of Medical Devices — Part 17: Toxicological Risk Assessment of Medical Device Constituents”, offers a more comprehensive guide for manufacturers and safety assessors.

It introduces new key concepts and contemporary methodologies, aiming to facilitate a more scientifically robust and efficient TRA process for medical devices.

Objective

In this upcoming webinar, our experts Sondy Chiu and Christy Li will discuss the updated procedures for performing toxicological risk assessments (TRA) in accordance with the new guidelines set by ISO 10993-17:2023.

They will unpack the new concepts introduced by the revised standard, including toxicological screening limit (TSL) and the estimated exposure dose (EEDmax), alongside the methodologies for TRA.

The session will conclude with two illustrative case studies, offering practical insights into their application.

Agenda

Introduction
Toxicological risk assessment process
Case study: A disposable oxygen mask
Case study: Non-absorbable polymer ligation clips
Q&A

Target Audience: The webinar is aimed at all those working in the medical device industry, especially those with interests in R&D, manufacturing and the biocompatibility testing of medical devices.

Language: English

Can't make a live session? Register now and receive a complimentary recording after the live event.