When we think about medical devices, it is easy to focus on how they function: does a pump deliver fluids accurately, does an implant provide the support it promises, does a monitor capture the right readings? Yet behind every design lies a more fundamental question: is the device safe for the human body itself?
That is where ISO 10993-1 comes in. For decades, this international standard has set the foundation for the biological evaluation of medical devices, making sure that the materials and components used in contact with patients or users do not cause harm. In 2025, a new edition of the standard was released. Known as ISO 10993-1:2025, it replaces the 2018 version and brings important updates that every manufacturer, developer, and regulatory professional should understand.
Why Biological Evaluation Matters
Whenever a medical device touches the human body—whether it is a surgical instrument, a diagnostic test strip, a catheter, or a long-term implant—the body responds. Sometimes these responses are harmless and temporary, but in other cases, contact can trigger irritation, toxicity, allergic reactions, or longer-term effects such as carcinogenicity or endocrine disruption.
Biological evaluation is the structured process of examining and reducing these risks. It combines:
- Understanding the materials used in a device,
- Assessing how and how long the device comes into contact with the body,
- Identifying potential hazards, and
- Confirming safety through data, testing, or established knowledge.
ISO 10993-1 is the cornerstone that defines how this evaluation should be carried out and documented.
What Has Changed in ISO 10993-1:2025?
The 2025 edition does not reinvent the wheel but refines it, making the process more scientific, more closely tied to real-world use, and more consistent with other standards such as ISO 14971 on risk management.
Some of the key updates include:
Closer integration with risk management:
Biological evaluation is no longer seen as a stand-alone exercise. It must now be fully integrated into a company’s overall risk management system, considering both hazards and how those risks are controlled and monitored.
Recognition of foreseeable misuse:
Devices are not always used exactly as intended. The new edition requires manufacturers to consider reasonably foreseeable misuse. For example, what happens if a wound dressing is worn longer than recommended? Or if a diagnostic strip is reused? These scenarios must be part of the biological risk analysis.
Clearer rules on exposure duration:
The way contact time is calculated has been refined. Manufacturers must now look at the total exposure a patient or user experiences, not just isolated moments. This could shift devices into a different risk category and require more thorough evaluation.
New categorisation of devices by contact type:
Instead of one large table for all devices, the new version divides evaluation by contact type—skin, mucosal surfaces, breached surfaces, blood contact, and so on. This makes the framework more precise but also demands that manufacturers carefully map their devices against the right table.
Stronger requirements for demonstrating equivalence:
Many companies rely on showing that their new device is “biologically equivalent” to an existing one to avoid unnecessary testing. The 2025 version provides clearer rules on when this is acceptable and what data must support it.
Greater emphasis on competent experts:
The standard highlights that biological evaluation must be carried out by people with the right expertise—such as toxicologists or material scientists—and that their qualifications must be evident. Regulators will want to see that competent professionals are involved in these decisions.
What Does This Mean for Manufacturers?
For manufacturers, the new edition brings both challenges and opportunities.
On the one hand, it demands more preparation, better documentation, and stronger scientific justification for decisions. Companies can no longer rely on a checklist approach or default testing; they need to explain why their evaluation is sufficient, how misuse has been considered, and how risk has been managed.
On the other hand, it also opens the door to more efficient pathways. With the clarified approach to equivalence and the emphasis on using existing data, companies may avoid unnecessary animal or laboratory testing—provided they can present a robust rationale.
The net effect is a more realistic, patient-focused evaluation that improves safety while giving responsible manufacturers a clearer path to compliance.
Practical Steps to Take Now
To prepare for ISO 10993-1:2025, companies should:
- Review their current biological evaluation plans and compare them with the new requirements.
- Update risk management processes to ensure biological hazards and foreseeable misuse are explicitly covered.
- Re-categorise devices using the new tables and confirm that exposure durations are calculated correctly.
- Gather and document existing data on materials and previous testing, identifying gaps early.
- Engage qualified experts and ensure their roles and credentials are clearly reflected in reports.
- Update templates, SOPs, and reports to match the new terminology and expectations.
- Train internal teams so that design, development, and regulatory functions are aligned with the updated requirements.
Looking Ahead
ISO 10993-1:2025 represents more than just a technical update; it reflects a broader shift in how the medical device industry approaches safety. By connecting biological evaluation more tightly with risk management, by recognising real-world use and misuse, and by raising the bar for expertise and documentation, the new standard encourages manufacturers to think beyond compliance checkboxes.
For patients, this means greater assurance that medical devices are safe, not just in theory, but in the way they are actually used. For manufacturers, it is both a responsibility and an opportunity—to design better, to document more clearly, and to build stronger trust with regulators and users alike.