We are pleased to announce that Nelson Labs will be present at the upcoming Medical Tubing Event on 5 – 6 October in Cologne, Germany.
Our Study Director for Medical Devices, Ans De Roeck will be presenting:
Highlighting changes in the new ISO 10993-18 guideline through a case study on catheters
Presenter: Ans De Roeck, Study Director Medical Devices
Recent changes in the medical device regulatory field such as the MDR implementation and revisions of the ISO 10993 series all put a higher emphasis on assessing risks associated with the use of medical devices to ensure patient safety in a better way.
In this presentation the most important changes in ISO 10993-18 will be highlighted such as the need to use screening methods in a chemical characterization study. The reason is the complex manufacturing process of a medical device (including sterilization steps) making it difficult to predict upfront which chemical compounds could be released from the medical device into the patient. In addition, the use of an Analytical Evaluation Threshold (AET) and the importance of accurate identification and quantification of compounds for a subsequent toxicological assessment is demonstrated by means of a case study on catheters.
For more information on this event, visit: www.ami.international