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The 2025 revision of ISO 10993‑1 introduces several important updates that reshape how manufacturers plan, justify, and document the biological evaluation of medical devices. The revised standard strenghtens the link between biological safety and risk management, redefines how exposure duration is determined, introduces new device contact categories, and clarifies requirements for using existing data and assessing sensitive populations.
Aligned terminology: The standard now adopts risk‑management terms such as biological hazard, biologically hazardous situation, biological harm, and residual biological risk, ensuring consistency across risk‑management documents
BEP/BER requirements:
Qualified personnel: Biological evaluation must be performed by individuals with demonstrable competence (toxicology, chemistry, clinical evaluation, etc.), supporting scientifically defensible decisions.
Greater emphasis on existing data and alternatives: The revised standard strengthens the use of existing data, chemical characterization, and alternative approaches to support biological safety assessments and avoids unnecessary animal testing.
ISO 10993‑1:2025 positions biological evaluation as a risk‑driven, lifecycle process rather than a standalone check. Biological safety must be actively managed, scientifically justified, and transparently documented—evolving with the device and its risks.
ISO 10993‑1:2025 introduces a use‑based, cumulative approach to defining exposure duration. This revised framework directly influences device categorization and the scope of biological evaluation.
Contact day:
Exposure is defined by contact days, meaning any day a device or its components contact the patient, regardless of contact duration within that day.
Total exposure period:
Device classification is based on the total number of contact days between first and last use.
Bioaccumulation default rule:
Materials or constituents with bioaccumulation potential must be classified as long‑term exposure, unless a scientific justification supports otherwise.
Exposure classification must include both intended use and foreseeable misuse, such as:
Under ISO 10993‑1:2018, devices with short contact durations could often be classified as limited exposure. Under the revised definition, repeated or intermittent use may shift a device into prolonged or long‑term exposure, unless scientifically justified otherwise. This reclassification can expand the required biological evaluation, particularly for systemic effects.
ISO 10993‑1:2025 replaces the traditional single contact matrix with four body contact categories, providing a clearer framework for selecting relevant biological endpoints.
Devices are classified according to where they contact the body:
Legacy terms such as “externally communicating devices” have been removed, simplifying classification and interpretation..
Each contact category table is associated with a set of core biological endpoints, which may include:
Depending on the device, additional endpoints may also need to be considered, such as immunotoxicity, neurotoxicity, reproductive and developmental toxicity, or material‑mediated pyrogenicity.
Key updates:
Devices within the same contact category may now require different biological evaluations, depending on exposure duration and use patterns. In particular, the mandatory inclusion of genotoxicity for prolonged or long‑term contact (except intact skin) represents a significant expansion compared to previous editions. As a result, use and exposure now drive both classification and endpoint selection.
ISO 10993‑1:2025 introduces a clearer and more structured framework for biological equivalence, defining when existing biological data from a comparable device or material may be used.
Biological equivalence is no longer based solely on similarities in material composition or manufacturing processes. Instead, the focus is on whether patient‑relevant biological risks are comparable under the intended conditions of use.
To support an equivalence claim, manufacturers must provide a clear and well‑structured scientific justification, documented within the Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER). This justification should demonstrate that the available data are applicable to the device under evaluation and adequately address its biological safety.
Demonstrating biological equivalence supports transparent and scientifically sound use of existing data and can reduce the need for additional testing, including animal studies, while maintaining patient‑relevant biological safety.
ISO 10993‑1:2025 places stronger emphasis on evaluating biological safety for sensitive or vulnerable patient groups, ensuring that potential risks are considered beyond the “average” adult user.
Who to consider:
Manufacturers should consider patient groups that may have increased susceptibility, including children and infants, elderly patients, chronically ill patients, pregnant individuals, women of child‑bearing age, and immunocompromised patients.
What to assess:
For these populations, it must be evaluated whether materials, leachables, or degradation products could result in different or higher biological risks compared to the general population.
Documented justification:
Any specific considerations related to sensitive populations must be identified, evaluated, and scientifically justified within the Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER).
Considering sensitive populations ensures that biological safety assessments reflect real‑world clinical use and patient diversity, supporting a more robust and clinically relevant evaluation.
The updated ISO 10993‑1:2025 framework places greater emphasis on structured documentation, risk‑based justification, and scientifically sound biological evaluation. We support manufacturers in meeting these expectations through targeted, expert‑driven services.
BEP & BER support
We prepare or update Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER) in line with ISO 10993‑1:2025, including:
Toxicological Risk Assessment (ISO 10993‑17:2023)
We perform dose‑response and exposure‑based toxicological risk assessments (TRA) compliant with ISO 10993‑17:2023, including the derivation of:
Study monitoring
We provide scientific oversight of biological and toxicological studies, ensuring alignment with the BEP, ISO expectations, and regulatory requirements.