As medical device manufacturers and regulatory professionals prepare for the release of the updated ISO 10993-1, significant attention is being paid to how this revision will reshape biological evaluations. While not a complete overhaul, the upcoming version—expected in late 2025—brings important refinements that align more closely with risk-based principles and regulatory expectations, especially those outlined in ISO 14971.

This blog post unpacks the key updates introduced in the draft version of ISO 10993-1 and explores what they mean for industry stakeholders.

Strengthened Alignment with ISO 14971: Risk at the Core

One of the most impactful changes is a tighter integration with the risk management framework of ISO 14971. This shift affects both terminology and structure:

• • The term “biological hazard” is now used consistently to identify the source of potential harm.
  • “Biological endpoint” is replaced with the clearer term “biological effect.”
  • A formal definition of “biological equivalence” is introduced, guiding how existing data can be used to avoid unnecessary testing.

This refined alignment encourages a structured approach to biological risk estimation and control, ensuring that the probability and severity of harm are systematically assessed. Where residual risk remains significant, risk control measures—such as design changes or additional labeling—must be implemented.

Acknowledging Misuse: “Reasonably Foreseeable” Now Required

Another notable addition is the requirement to consider reasonably foreseeable misuse. Evaluations can no longer be limited to a device’s intended use; manufacturers must now assess how devices might be used incorrectly, but in predictable ways.

For example, if a product could be inserted in an unintended anatomical location or reused improperly, those scenarios must be evaluated using the same risk management methodology as intended use. This broadens the safety net and ensures more comprehensive user protection.

New Structure for Biological Effects: Out with the Old Matrix

The familiar categorization matrix—a staple of previous versions—is removed in the new update. In its place are several new tables, each tailored to a specific type of body contact, such as:

• Surface contact
• Mucosal contact
• Implantable devices

Importantly, the item “Physical and chemical information” is no longer listed as a biological effect. However, this doesn’t reduce its importance. It is now addressed under material characterization and risk analysis, reaffirmed in Annex A, which emphasizes informed material selection.

This reorganization improves clarity and specificity, helping evaluators identify relevant effects based on contact type more efficiently.

Exposure Duration Reimagined: Introducing the “Contact Day”

Device use patterns are evolving, and so is how we categorize them. The revised ISO 10993-1 introduces the term “Contact Day”—defined as any day a device makes contact with the user, regardless of the duration.

For devices used daily or intermittently, the update provides detailed guidance on how to calculate cumulative exposure time. These calculations may lead to a re-categorization of exposure duration, potentially triggering the need for additional biological evaluations based on longer-term exposure risks.

Life Cycle Awareness and Ethical Testing

The update also gives more attention to the entire life cycle of medical devices. From manufacturing and storage to transport and reuse, biological evaluations must now account for possible material changes throughout a device’s journey.

For reusable devices, this includes the impact of cleaning, sterilization, and repeated handling.

Additionally, the revised standard reaffirms its commitment to ethical testing by further endorsing the 3R principle:

• • Replace animal testing when alternatives exist,
  • Reduce the number of animals used,
  • Refine experiments to minimize harm.

This clear directive aims to limit in vivo testing to cases where it is absolutely necessary, reinforcing a more responsible approach to biocompatibility assessments.

What It Means for Manufacturers

The revised ISO 10993-1 should be seen not as a disruption but as a natural evolution of an already robust standard. It enhances clarity, reinforces alignment with global risk principles, and introduces safeguards for both users and test subjects.

Crucially, the new version does not mandate re-testing of already approved medical devices. However, manufacturers are expected to reassess their documentation to ensure previous conclusions remain valid under the updated framework. If biological equivalence or other risk factors are affected, updates to the biological evaluation report may be necessary.

Final Thoughts

The upcoming ISO 10993-1 standard represents a meaningful step forward in biocompatibility evaluation—especially in its support for ethical testing, lifecycle awareness, and modern risk management. For medical device developers, this is an opportunity to refine evaluation strategies, reduce unnecessary testing, and strengthen regulatory submissions.

Staying ahead of these changes means being proactive. Whether you’re preparing a new submission or reviewing existing devices, aligning with the new ISO 10993-1 early will ensure smoother pathways through regulatory hurdles.

📘Source:
Congenius AG. (2025). ISO 10993-1: What’s New in the Latest Draft Standard.

Retrieved from https://congenius.ch/iso10993-1-whats-new-in-latest-draft-standard/