ISO 10993-1:2025 has recently been published, introducing important updates to the cornerstone standard for the biological evaluation of medical devices. ISO 10993-1 plays a critical role in defining the principles and requirements for assessing the biological safety of medical devices within the broader risk management framework established by ISO 14971.
The standard guides manufacturers and evaluators through a structured process to identify, assess, and control biological risks associated with device materials, design features, and the nature and duration of contact with the human body during intended use. Given the wide range of medical devices—from long-term implants and wound dressings to surgical instruments and personal protective equipment—ensuring biocompatibility is essential to protect patients and users from unintended biological harm.
By providing a consistent, science-based approach to biological evaluation, ISO 10993-1 supports manufacturers in demonstrating biological safety, meeting global regulatory expectations, and minimizing unnecessary animal testing. It also underpins international market access, serving as a key reference for regulators, notified bodies, and manufacturers worldwide.
Key Updates Introduced in ISO 10993-1:2025
The 2025 revision includes several notable changes aimed at improving clarity, consistency, and alignment with risk management principles:
- Stronger alignment with ISO 14971: The revised standard more closely mirrors the language, structure, and logic of ISO 14971. Risk management concepts are more deeply embedded throughout the text, reinforcing the expectation that biological evaluation is an integral part of a device’s overall risk management process.
- Explicit inclusion of reasonably foreseeable misuse: In line with ISO 14971, the scope of biological evaluation now clearly includes reasonably foreseeable misuse. Manufacturers must consider biological risks not only under intended use, but also under conditions of foreseeable incorrect use.
- More precise definition of exposure duration: The update places greater emphasis on understanding exposure in terms of daily contact and total exposure over calendar days. the update highlights that brief, repeated contacts would need to be assessed cumulatively.
- Replacement of the former matrix with contact-specific tables: The previous Annex A matrix has been replaced by clearer, contact-specific tables incorporated into the main body of the standard. These tables link different types of body contact—such as skin, mucosal membranes, breached or internal tissues, and blood—to the relevant biological effects that should be evaluated.
The updated standard can be accessed using the following link
