Stay Ahead with ISO 10993-1:2025 – The New Standard for Biological Evaluation of Medical Devices
Understand the updates, integrate them into your risk management, and ensure global compliance for your medical devices
About ISO 10993:1-2025
About ISO 10993:1-2025
The new ISO 10993-1:2025 standard for the biological evaluation of medical devices has officially been published, marking a significant evolution in biocompatibility assessment. This long-awaited revision moves the industry further from a traditional, checklist-based testing matrix and firmly establishes a comprehensive, risk-based approach as the new benchmark for biological safety.
This update brings critical changes, most notably a much stronger and more explicit integration with the overall risk management framework defined in ISO 14971. For medical device manufacturers, this alignment is no longer optional; it's a fundamental requirement. Biocompatibility assessment must now be a deeply integrated component of the device's complete risk management file, not a standalone activity.
Key changes introduced in ISO 10993-1:2025 emphasize a "thinking-first" methodology. This places significant new focus on material and chemical characterization and subsequent toxicological risk assessment as the foundational steps of any evaluation. The goal is to comprehensively understand a device's material components and potential leachables before resorting to biological testing.
These changes will have a direct and substantial impact on your entire product lifecycle and quality system. This includes the strategic development of your Biological Evaluation Plan (BEP), which must now be more robust and justification-driven, as well as the content and structure of your final Biological Evaluation Report (BER). The standard also fundamentally alters the justification process for (or against) conducting in vitro and in vivo biological tests and strengthens the link between pre-market data and post-market surveillance (PMS) activities.
Understanding and proactively implementing the requirements of ISO 10993-1:2025 is essential for all medical device manufacturers to ensure global regulatory compliance, maintain patient safety, and streamline product submissions. This standard affects how you assess device risk, plan your evaluations, and document your safety rationale from concept through to post-production.
To guide you through this transition, we have prepared three key resources to suit your learning needs and business requirements:
The High-Level Overview – Our New Blog
Get a concise, expert analysis of the most significant changes from the 2018 version, and understand what they mean for your Biological Evaluation Plans (BEPs) and Reports (BERs).
The Deep Dive – 2-Hour E-Learning Course
Master ISO 10993-1:2025 with our comprehensive e-learning course, led by Qserve’s Biocompatibility Expert, Dr. Patrícia da Silva Perez, an active member of the ISO/TC 194 committee.
The Custom Solution – Tailored Q&A
Combine your e-learning with a 2-hour remote Q&A session, designed specifically for your company’s devices and unique challenges.
Ensure your devices remain compliant with practical guidance from our experts.