Workshop Agenda

13:00 Introduction to Extractables and Leachables

• Origins of E&L
• Terminology

13:45 Regulatory - ISO 10993-18, FDA

• Regulatory structure and organisations
• Medical devices - regulatory definitions
• Device categories and risk
• Combination products

14:45 Break

15:00 Chemical characterisation, Extractables, Leachables

• Best practices
• Study design - hypothetical chemical release, exhaustive extraction, leachables etc.
• Thresholds
• Toxicological evaluation - where does this fit in?

16:00 Experimental

• Techniques: GC-MS/LC-MS/ICP/SH GC-MS etc.
• Interpretation of results
• Method development/validation
• Dealing with unknowns
• Toxicology again

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