A single example in ISO 10993-1:2025 is the tip of a much larger problem — and standard analytical screening will likely miss it entirely. When ISO 10993-1:2025 was published, most of the industry’s attention landed on contact duration calculations and the updated biocompatibility evaluation framework. Understandably so. But tucked into clause 6.4.3.3 is something that deserves its own conversation: the explicit callout of PFHpA (perfluoroheptanoic acid, CAS 375-85-9) — a per

Published: May 2026 | Author: Sandi Schaible "Forever chemicals" have become one of the defining regulatory stories of the decade. Per- and polyfluoroalkyl substances — PFAS — are synthetic chemicals that do not break down in the environment or the human body. They have been found in drinking water, soil, fish, and the blood of people around the world. Regulators in the US, Europe, and beyond are setting ever-stricter limits, and industries that have relied on these mate

In the world of medical devices, combination products and pharmaceutical products, extractables and leachable (E&L) testing is often viewed as a regulatory checkbox. But for those of us who’ve spent decades in the trenches of chemical characterization, we know that “good” E&L isn’t just about meeting minimum requirements—it’s about solid data to support a risk assessment to protect patients, enable innovation, and build trust. So, what does good E&L look like? Good E&L testin

In today’s medical device landscape, biocompatibility is no longer a checkbox-it’s a strategic pillar of product safety and regulatory success. With the upcoming release of the latest revision to ISO 10993-1 (currently a Final Draft International Standard (FDIS)), the integration of chemical characterization (ISO 10993-18) and toxicological risk assessment (ISO 10993-17) is more critical than ever. These standards now align closely with I SO 14971:2019 Medical devices-Applica