Future Path for E&L per ISO 10993‑18: A Look at Emerging Technical Specifications

ISO 10993‑18 is entering a new phase as several technical specification (TS) documents are developed to address long‑standing gaps and confusion in chemical characterization. These TS efforts aim to bring greater clarity to extraction design, identification confidence, quantitation strategies, and quality for better alignment with ISO 10993‑17 for toxicological risk assessment.

This presentation summarizes the TS documents currently in development, outlines their intended scope, and highlights how they may reshape expectations for E/L study design and reporting. Attendees will gain a concise view of where ISO 10993‑18 is heading and practical insight into how these evolving documents may influence regulatory submissions and laboratory practices in the future.

Presented by Sandi Schaible, President and Founder of Bonded in Science, LLC

Sandi Schaible is the President and Founder of Bonded in Science, LLC a consulting firm dedicated to delivering scientific strategy and regulatory guidance for the MedTech and Pharma/BioPharma industries. She has more than 35 years of experience—including nearly three decades in contract research organizations and 20 years in executive laboratory leadership.  As an international expert and active member of ISO TC194/WG14 for nearly a decade, and recently elected to serve as an expert to ISO TC194/WG1, Sandi offers unparalleled expertise in analytical chemistry, biocompatibility, and regulatory strategy for extractables and leachables (E&L).

Sandi has led organizations through complex analytical transformations, building robust programs that combine scientific rigor, regulatory compliance, and a customer-centric approach. Her work spans both medical device and pharmaceutical sectors, helping clients meet global regulatory expectations for E&L testing.

Through Bonded in Science, Sandi provides advisory and leadership support to laboratories, positioning them as trusted partners in regulated industries. She also delivers training and analytical support to MedTech and Pharma clients while actively contributing thought leadership and collaborative initiatives that advance the science of extractables and leachables.

Followed by a live question and answers session