Outcome
The participants will be trained in toxicological assessment of substances in compliance with ISO10993-17:2023.
 
Content
A revised version of ISO10993-17 was issued in 2023. This course is designed to provide training in toxicological assessment of substances from medical devices in accordance with ISO10993-17:2023. Changes compared to the previous version of this standard, from 2002, will be described. Experienced specialists will learn how their toxicological assessment practices should be changed and inexperienced specialists will become familiar with the current requirements.
 
The course will address:

• The changes in ISO10993-17:2023 compared with ISO10993-17:2002
• How to make toxicological assessments of substances in compliance with ISO10993-17:2023. This will include how to determine the applicable exposure level and toxicological limit together with how to calculate the margin of safety. 

The course will include a workshop with case studies that will illustrate the best practices for toxicological assessment in compliance with ISO10993-17:2023.
 
Who should attend?
The course will benefit Biosafety Specialists with experience of the toxicological assessment of substances according to ISO10993-17, while those without this experience will also gain valuable insights into the current toxicological assessment practices described in this recently revised standard. Other specialists who review or use the toxicological assessments, e.g. Regulatory and Quality Specialists, will also benefit from the course.
 
Trainers
Nicholas Edwards, Senior Toxicologist, DHI
Brian Svend Nielsen, Principal Toxicologist, DHI