2‑Part Live Webinar Series ISO 10993 Updates in Practice: From E&L Testing Challenges to ISO 10993‑1:2025 Revisions

Part 1:
ISO 10993‑18 in Practice: Addressing Common Challenges in Extractables & Leachables Testing

ISO 10993‑1 is the standard that outlines the framework for the biological evaluation of medical devices. It establishes the regulatory requirements for assessing potential risks arising from a device’s materials, intended use, and patient contact. The November 2025 revision introduces several updates to key biocompatibility concepts while maintaining the standard’s fundamental role in supporting biological evaluation within a risk‑management framework.
This presentation will outline the most significant changes to ISO 10993-1 and examine how they affect the design of biological assessment strategies. Key topics include the enhanced alignment with ISO 14971 regarding risk management principles, the updated considerations for biological effects, and the strengthened emphasis on lifecycle based evaluation.

Presented by Elisabet Jamez, Biocompatibility Expert at Nelson Labs

Elisabet Jamez holds a master’s degree in Industrial Engineering in Chemistry and joined Nelson Labs in 2019. Elisabet is subject matter expert (SME) in extractables and leachables testing for medical devices. She has years of experience in developing extractables and leachables study set-ups and writing the subsequent reports.
In 2023, she evolved in her role to become part of the Nelson Labs Expert Advisory Services team as Biocompatibility Expert. Elisabet uses her extensive knowledge in extractables and leachables to write biocompatibility assessments that are targeted for regulatory submissions all over the world.
Elisabet is an active member of several International Organization for Standardization (ISO) committees related to the biological evaluation of medical devices.

Part 2:
ISO 10993‑1:2025: Key Revisions and Implications for Biological Evaluation Strategies

E&L testing according to ISO 10993-18 followed by a toxicological risk assessment (TRA) according to ISO 10993-17 can replace biological testing to assess systemic endpoints, e.g. carcinogenicity, genotoxicity, hereby reducing costs and saving time and animals. This presentation will give you an introduction on how E&L testing is performed at Nelson Labs and possible ways out for challenges that can be encountered.
The presentation will start with a brief introduction on E&L testing for medical devices, as described in ISO 10993-18. Throughout the subsequent step-by-step explanation of how a study is performed at Nelson Labs, possible challenges and solutions are discussed. Challenges encountered in sample requirements, extraction conditions, exhaustivity determination, sample preparation and more will be discussed.

Presented by Wouter Buyssens, E&L Project Manager at Nelson Labs

Wouter Buyssens received his master’s degree in Industrial Engineering with a specialization in Chemistry in 2017 from the University of Leuven. From 2018 to 2021, Wouter worked as a Product Specialist at Michelin, where he contributed significantly to customer satisfaction. He joined Nelson Labs in 2022 as a Scientific Project Manager, widening his expertise in Extractables and Leachables for Medical Devices according to ISO 10993-18, designing study setups and writing comprehensive reports. In 2025, he further expanded his expertise and responsibilities to include Combination Products and Large Volume Parenterals, reinforcing his role as a multidisciplinary asset within the company.

Sponsored by Nelson Labs

Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Nelson Labs serves over 3,000 customers across 13 facilities in the United States, Mexico, Asia, and Europe.  We provide our customers with mission-critical testing services, which assess the quality, effectiveness, and end-to-end sterility of products and, ultimately, the impact of the products on patient safety. These services are necessary for our customers’ regulatory approvals, product releases, and ongoing product performance evaluations.  We have over 900 laboratory tests supporting our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety, and quality assurance.  Pharmaceutical lab testing services include microbiology, biocompatibility and toxicology assessments, extractables and leachables evaluations of pharmaceutical containers, sterilization validation, sterility assurance, packaging validation and distribution simulation, and facility and process validation.  We also provide expert advisory services to help customers navigate the regulatory requirements applicable throughout their product’s lifecycle. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.