ISO 10993-1:2025 update has been published 7 years after the previous edition on November 18, 2025. The sixth edition of ISO 10993-1 is shifting Medical Device compliance as new processes have been added, and certain biological evaluation procedures have been changed.
ISO 10993-1:2025 primary goal is to specify requirements and general principles governing the biological evaluation of medical devices within a risk management process according to ISO 14971. As a matter of fact, this latter must assess biological safety by considering risks associated with the device’s constituents and tissue-device interactions (including physical effects).
The standard’s scope covers the entire life cycle of the medical device, from design and development through final use, taking into account even the risks arising from reasonably foreseeable misuse.
What are the main differences between the previous 10993-1 standards?
The Sixth edition introduces several fundamental changes aimed at reinforcing the risk-based approach and clarifying terminology and categorization.
Let’s break down the main changes of the standard:
How can Medical Device Manufacturers be ISO 10993:1 compliant in 2025?
For manufacturers, the transition to the 2025 edition requires strategic updates to documentation and testing programs:
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Stronger Emphasis on Risk Management and Chemical Characterization
The biological evaluation must be conducted within the ISO 14971 risk management framework. The process emphasizes the initial gathering of physical and chemical information as a crucial first step.
- Daily contact: is when a medical device comes into contact with the body every day for any portion of a day. For these medical devices, the total exposure period is the number of calendar days from the first to the last use of the medical device or a replacement of the same medical device on a single patient
- Intermittent contact: is the use of the device where there is a period of at least 24 hours between consecutive tissue contacts. This type of contact can therefore be considered repeated use of one medical device or a replacement of the same medical device under consideration. For these medical devices, the total exposure period is calculated by adding the number of contact days from the first to the last use of the medical device on a single patient. This calculation of total exposure duration applies regardless of how long a single device is used for on a particular day.
Please note that the potential for bioaccumulation of medical device constituents shall be considered for all duration categories. Where bioaccumulation is expected (e.g. a raw material contains perfluoro-heptanoic acid, a substance known to bioaccumulate in humans), the contact duration of the medical device shall be long-term unless otherwise justified.
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Different calculations of exposure duration
Biological evaluations must be conducted within the ISO 14971 risk management framework. The process emphasizes the initial gathering of physical and chemical information as a crucial first step.
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Recategorization and Focus on Local Effects
Now that the “externally communicating” category is no longer required, manufacturers need to accurately categorize their devices based on the specific tissue contact (e.g., internal tissues, breached surfaces, or circulating blood). The change in terminology to “local effects after tissue contact” is significant.
- Impact: Evaluation for local effects after tissue contact is now explicitly required for medical devices in prolonged or long-term contact with tissues, excluding intact skin. This broadens the scope of assessment formerly known as “implantation effects” to include many non-implanted devices that maintain tissue contact over time.
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Expanded Requirements for Genotoxicity
Genotoxicity evaluation requirement now applies to virtually all prolonged contact devices (more than 24 hours up to 30 days) that have the potential for systemic exposure (mucosal membranes, breached surfaces, internal tissues, and blood).
- Impact: If a device falls into these prolonged contact categories, manufacturers must conduct a Genotoxicity evaluation (ISO 10993-3). Since each additional exposure to a genotoxic constituent increases the cancer risk, strong toxicological justification (often through chemical risk assessment per ISO 10993-17) is necessary to waive this evaluation.
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Handling of Historical (Legacy) Devices
The new edition provides clarity regarding devices already on the market with established safety profiles.
- Impact: The ISO 10993-1:2025 does not mandate re-testing of devices with acceptable safety histories. However, the historical information must be systematically reviewed and documented to ensure that any differences (e.g., changes in design, updated literature, or newly identified biological effects) do not impact the safety conclusion. If any changes described in Clause 10 (Production and post-production activities) occur, a review using the current version (2025) is mandatory.
In conclusion, the ISO 10993-1:2025 standard is shifting the industry further toward a comprehensive, science-based and risk-driven evaluation, favoring predictive chemical and physical analysis over traditional vivo biological testing, where justified.
If you have any questions regarding the impact of ISO 10993-1 changes in your medical device testing program, ChemSafe toxicologists are available to support your device-specific questions and help you design a test program that meets the current regulatory requirements.
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