A Guide to Staying Informed on the Latest ISO 10993 Standards

Developing a medical device is no small feat; keeping up with biocompatibility evaluation expectations isn’t either. Biocompatibility standards and regulations—and maintaining compliance—are a constant process. The best way for teams to meet these changing biocompatibility expectations is to ensure they’re working with the most updated standards.

ISO standards are eligible to be updated every five years and the latest ISO 10993-1 update included significant changes. The sixth edition of ISO 10993-1:2025, “Biological evaluation of medical devices – Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process” was officially published in November 2025. The changes are substantial, with the authors of the update describing it as a complete rewrite to more directly incorporate ISO 14971 risk management. 

In May 2026, the FDA partially recognized the sixth edition of ISO 10993-1:2025, excluding Clause 6.9 (Biological risk estimation) and the phrase “consumer products” in clause 6.5.11.3. European Union Medical Device Regulation (EU MDR) typically considers the latest edition of standards as “state of the art.” 

Considering the extent of the changes, it’s paramount for medical device manufacturers to start making changes to their biocompatibility process as soon as possible. The earliest edition of ISO 10993-1 resulted in a checkbox exercise of matching the device with its contact nature, then running the listed tests and submitting results. The recent edition leaves no space for this legacy approach. Today, biocompatibility evaluation is a risk-management process requiring simultaneous understanding of the device, its materials and manufacturing, contact nature, and the clinical context. Testing should occur when scientifically justified. Would generating additional data with testing serve to better estimate biological risks in humans?

Misunderstanding this complex standard is one reason why manufacturers frequently over-test, under-test, or test at the wrong time—often resulting in additional costs, time, and frustration.

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Key Changes 

The ISO 10993-1 shift to a risk-management process includes several major changes: 

• Identifying reasonably foreseeable misuse. Reasonably foreseeable misuse means scenarios where a medical device is used in a way not intended by the manufacturer. Manufacturers aren’t expected to think through every potential harmful situation that may arise from misusing a medical device. Instead, the focus should be on practical, risk-based misuse scenarios that can be predicted based on typical human behavior, intended user population characteristics, and the device’s context of use. Potential misuse situations could result from misunderstandings, insufficient knowledge, or vague instructions for use, which can be identified through clinical literature, known off-label use, and post-market data. When reasonable misuse scenarios are identified, manufacturers can implement appropriate risk control measures during the biological evaluation process.
• Considering bioaccumulation. The standard added that manufacturers must consider bioaccumulation in terms of materials and chemicals found in devices. This change puts a heavier emphasis on chemistry and toxicology to determine if a chemical bioaccumulates. 
• Direct incorporation of the risk management standard. The ISO 10993-1 standard mirrors ISO 14971, which is the risk management standard, meaning there’s a lot more risk language.
• Contact duration. The updates change how to determine the contact duration. In the past, if a device contacted a person for one hour a day for five days, it would be considered a total of five hours of contact, and the device’s contact duration would be limited (≤24 hours). But under the new revision, each daily, one-hour contact counts as one contact day, bumping it to the prolonged contact category. This change is significant because if a device is bumped to longer contact durations, there could be additional biological effects to consider. 

The Importance of Gap Assessments

When there’s a change to an ISO standard, it’s critical for manufacturers to start with a standard gap assessment to determine how the updates impact historical data and ongoing planned submissions to the FDA, MDR, or other regional requirements. Gap assessments reveal specific gaps between older versions and the latest versions of an ISO 10993 standard and help manufacturers determine if additional effort is needed to meet the updated standards.

Standards referenced in the biological evaluation report (BER) should be documented, including the year or edition of the standard utilized. It’s possible to reference previous editions of the standard. For example, FDA accepts declarations of conformity to ISO 10993-1:2018 until July 1, 2029, so be clear in your BER which ISO 10993-1 edition (2018 or 2025) you referenced. When it comes to submitting external test reports as part of the BER, you will also need to identify the 10993 standard version(s) to which testing was performed. If the test reports were performed according to a superseded version, you will need to perform a gap assessment and rationale.  

A standard gap assessment applies not only to new product development but also to:

• Any devices previously approved that are undergoing re-certification. The process helps to identify differences between existing documentation and the new requirements. 
• Design changes—including device design, materials, and manufacturing. Even minor modifications could require a gap analysis to determine if the change impacts patient safety. For example, new material suppliers or formulations, switching or adding new adhesives or coatings, changing cleaning chemicals or sterilization. 

Ultimately, one of the biggest mistakes we see manufacturers make is overlooking the gap assessment step. Being proactive in performing gap assessments and identifying additional evaluation steps as needed will help ensure each device complies with current biocompatibility requirements.

Get Involved and Stay Informed

While staying on top of ISO, FDA, and EU MDR changes can feel daunting, we encourage medtech leaders to get involved in the process to ensure your perspective is represented. At Hohenstein Medical, we’re actively involved in the ISO process so we’re notified when a standard is changing, can provide our input on the standards and changes, and understand why the changes are being proposed. I participate in the Association for the Advancement of Medical Instrumentation (AAMI) Standards Development Committee, and AAMI collates all participants’ feedback on the standards and revisions and shares it with the ISO. 

Our German team is actively involved in the German counterpart to AAMI called Deutsches Institut für Normung (DIN). They also review and provide input on the ISO standards that impact EU MDR.

Educational webinars and conferences are also a great way to learn more about changing standards and regulations. For example, my colleague Isabel Groh, senior toxicologist and biocompatibility expert, and I will be speaking on the topic, “Decoding Biocompatibility for Medical Device Design Changes” during MD&M West 2027 in Anaheim. 

A Team Effort

Medical device development is challenging and complex with science, medicine, and regulation all an important part of the mix, so it’s normal to feel overwhelmed at times, especially when it comes to something as nuanced as biocompatibility. You don’t have to navigate that complexity on your own—lean on your cross‑functional team, your network, and subject‑matter experts.

If you’re running into questions about ISO 10993 standards, materials, test strategies, or how to interpret biocompatibility for your device, that’s the perfect moment to pause and ask for help rather than push forward on your own. Our collaborative, context-driven biocompatibility evaluation sets us apart. We partner closely with manufacturers, asking the right questions and drawing from our deep experience and expertise to confidently define the optimal biocompatibility strategy. A conversation early on can save months of rework and, more importantly, help ensure patients receive safe, effective products.

Three key takeaways:

• It’s critical to stay informed about the changing ISO standards to remain in compliance. 
• Revisions don’t necessarily require re-testing. A gap analysis is important to determine specific needs.
• Actively participate in standards development to become more involved.

More insights from this author: Integrated Approaches to Reduce Use of Animals in Biocompatibility Testing

Kathryn Brinkman leads the development and strategic positioning of Hohenstein Medical’s medical device biocompatibility program, with focus on chemical characterization, ISO 18562 gas pathway testing, and ethical, non-animal assays. Brinkman has over 15 years of experience in biological sciences, authoring numerous biocompatibility and toxicological risk assessment reports supporting global regulatory submissions. Brinkman earned a bachelor of science degree in biology from Mississippi University for Women, is an active member of the Society of Toxicology and the Regulatory Affairs Professionals Society, and is also certified as a Biological Safety Specialist by NAMSA.