WHY SHOULD I JOIN THE WORKSHOP?
The new version of ISO 10993-18 Chemical Characterization of Medical Devices has been published in January 13th, 2020. Also the compliance with the new MDR will converge to the approach settled by the new approach of ISO 10993-1:2018 for Biological Evaluation of medical devices.
If compared with the previous edition the new Standard increases the level of integration and harmonization with current versions of ISO 10993-1 and ISO 10993-17. The focus of chemical characterization emphasizes raw materials evaluation also taking into account the presence of any impurities or residues associated with the manufacturing and sterilization process that may impact medical devices biocompatibility.
Chemical characterization becomes a key factor in the assessment of the biological evaluation since obtained data are fundamental to correctly set the biological risk assessment of medical devices and also to plan how to evaluate biological effects relevant to the device.
The new version of ISO 10993-18 specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization.
WHO SHOULD PARTICIPATE?
- Regulatory affairs and QA experts
- Research, design & manufacturing engineers
- Experts involved in the evaluation of Medical Devices
- Product Managers & Laboratory Managers
- Process development & system engineers
- Toxicologists & biological safety experts
- 09:00 Registration for Workshop
- 09:30 Regulatory and normative overview: Relation between MDR, ISO 10993-1 and chemical characterization
- 11:00 Coffee break
- 11:15 Biological evaluation of medical devices according to ISO 10993-1 and chemical characterization
- 12:00 Purpose of chemical characterization
- 1230 Stepwise approach
- 13:00 Lunch Brake
- 14:00 Extractables & Leachables studies:
- Extraction conditions
- Analytical techniques and levels of identification
- Substance-based medical devices
- 15:45 Coffee break
- 16:00 Interpretation of data obtained from chemical characterization: Toxicological evaluation according to ISO 10993-1
- 17:00 F2F meetings
EVENT KEY NOTE SPEAKER?
Paolo Pescio, ERT
- 15+ years of experience with medical devices
- European Registered Toxicologist (ERT)
- HAS consultant
- Toxicological evaluation and risk assessment
- Biological evaluation of medical devices
- Integrated Testing Strategies
- Guidelines and Training Materials
- Eurofins & Edu-Med Certificate
A certificate of attendance for professional development will be given to each participant who completes the workshop.