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Chemical Characterization of Medical Devices Workshop

Upcoming Virtual Courses

Biological Evaluation

Chemical Characterization for Medical Devices Workshop (August 2025)

Aug 18 to Aug 21, 2025

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Overview

This course provides an in-depth exploration of the chemical characterization process essential for assessing the biocompatibility of medical devices. Participants will gain insight into the latest regulatory expectations worldwide, with a focus on compliance with ISO 10993-17, ISO 10993-18, and industry best practices. The course will cover key areas, including the fundamentals of polymers and materials science, the extraction and data collection process for extractables and leachable’ s (E&L), and the toxicological risk assessment of E&L data. Through a structured curriculum, participants will learn to navigate the complexities of chemical characterization step-by-step, ensuring they can effectively address regulatory requirements and enhance the safety profiles of medical devices.

 

Objectives

Over the course of sixteen (16) hours, the attendee/learner will be able to: 

  1. Understand Fundamentals for Polymers/Materials Relatable to Medical Devices:  

  • Gain a solid understanding of polymer science fundamentals, including the differences between thermoplastics and thermosets and common potential extractable sources.  
  • Learn how these factors impact the safety and biocompatibility of medical devices.  

  1. Understand Extractables and Leachable’ s (E&L) Profiling of Medical Devices: 

  • Learn the essential practices and methodologies for E&L profiling, including solvent selection, the effects of materials of construction, and the impact of extraction conditions (time, temperature, pH).  

  • Understand how E&L studies are carried out and assess laboratory capabilities to ensure compliance with ISO 10993-18. 

  1. Understand Process of the Toxicological Risk Assessments of E&L Data:  

  • Acquire the skills to use E&L data in reviewing toxicological risk assessments (TRA) reports as per ISO 10993-17:2023. This includes grouping chemicals, deriving tolerable intake, and handling chemicals with limited data 

  • Evaluate whether TRAs meet regulatory standards and ensure the safety of medical devices. 

What to expect

  1. Introduction to ISO 10993-1, ISO 10993-17, and ISO 10993-18 
  • Chemical characterization in lieu of animal testing for systemic toxicity, reproductive toxicity, genotoxicity, carcinogenicity 

  1. Extent of recognition of chemical characterization (ISO 10993-18 and -17) in the US, EU, and other regions 

  1. Examples of chemical characterization deficiency comments by regulatory agencies 

  1. Fundamentals of polymers/materials science 

  • Basics of organic chemistry

  • Monomer vs Polymers and their relation to medical devices

  • Common Polymeric Systems: Thermoplastics vs Thermosets 

  • Other Materials (i.e., Metals, Ceramics, Drugs, Biologics)

  • Polymers Properties and Processing Effect on Extractable/Leachable Profile  

  • Dissolution/Swelling of Polymeric Materials  

  1. ISO 10993-18: Extractables and Leachables (E&) & Analytical Chemistry  

  • Basics of Extractions: Solvent Selection, Temperature, Time, pH, Ratios, Materials Effect

  • Exhaustive vs Simulated Extractions

  • Challenges with Exhaustive Extraction

  • Solvent Selection for Extractions

  • Introduction to analytical chemistry (HS-GC/MS; GC/MS; LC/MS; ICP/MS)

  • Application and Calculation of AET

  • Identification and Quantification of Extracted Chemicals

  • Addressing Unknown Chemicals

  • Benefit of Priori materials/device assessment

  • Tips for Screening a Laboratory: Protocol and Report 

  1. Toxicological Risk Assessment in Relation to ISO 10993-17 

  • Data Sorting and Cleaning for Risk Assessment (e.g., Grouping Chemicals) 

  • Using TSL vs TI to Establish Chemical Safety 

  • How to find relevant toxicological safety information for an identified constituent/chemical?  

  • Deriving TI and MOS for Chemicals 

  • How to leverage MOS and other literature to determine safety of a chemical for a biocompatibility endpoint?  

  • Handling Chemicals with No Data 

  • Fundamentals of Surrogate Selection for No-Data/Low-Data Chemicals 

  • Tips for a Complete Toxicological Risk Assessment 

  1. Case Studies and Practical Exercises 

Who Should Attend?

Professionals in the medical device industry with expectations to comment or carry out biocompatibility-related tasks in their position such as:  

  • Regulatory Affairs and Quality Assurance Professionals 

  • Research, Design and Manufacturing Engineers 

  • Microbiologists and Chemists involved in the evaluation of Medical Devices 

  • Product Managers, Laboratory Managers 

  • Process Development and System Engineers 

  • Toxicologists and Biological Safety Specialists 

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.

Faculty

Amir Rahimi, Ph.D., DABT

Subject Matter Expert|Materials Science, Chemistry, Toxicology, and Biocompatibility