What ISO 10993-1:2025 and FDA’s Partial Recognition Mean for Your Biological Evaluation Plan
Affiliate Disclosure: Some links in this article are affiliate links. If you purchase through them, The Standards Navigator may earn a commission at no additional cost to you.
The Standard Behind Your Biocompatibility Testing Just Changed — Is Your Documentation Still Defensible?
Biocompatibility standards for medical devices just changed in a way regulatory affairs teams can’t ignore. If your device has any contact with the human body, your biological evaluation plan rests on one standard: ISO 10993-1. For years, that meant the 2018 edition. That’s no longer the whole story.
ISO published a sixth edition, ISO 10993-1:2025, in November 2025. The FDA followed with recognition of that edition on May 25, 2026 — but only partial recognition. Two specific clauses were excluded outright. If your technical documentation, supplier certificates, or biological evaluation reports still cite the 2018 edition without addressing what changed, that’s a gap a reviewer or auditor will find.
This isn’t a cosmetic update. The reorganization ties biocompatibility more tightly to ISO 14971 risk management, and the FDA’s exclusions tell you exactly where the agency still wants you to lean on its own biocompatibility guidance instead of the standard’s language. This guide covers the current medical device biocompatibility testing requirements under both editions, what changed, and what FDA’s recognition decision actually means for your Biological Evaluation Plan (BEP).
I’ve been on the reviewing side of this problem before, just from the documentation control angle. As an ISO 9001 internal auditor, I’ve flagged design history files where a supplier’s certificate of conformance still referenced an outdated edition of a cited standard — the technical content hadn’t changed, but the paper trail no longer matched what the standard actually required. That’s the kind of finding that stalls a submission or an audit closeout, and it’s entirely avoidable if someone catches the edition mismatch before a reviewer does.
Before you touch a single test report, run a gap check on where your current documentation stands against the 2025 edition.
👉 Most teams don’t fail because their biocompatibility data is wrong — they fail because their documentation still points to the wrong edition of the standard. Run the ISO 13485 Gap Assessment Checklist before your next submission or audit →
In This Guide
- What ISO 10993-1 covers and why it sits at the center of biocompatibility evaluation
- The full ISO 10993 series, part by part
- What actually changed in the 2025 edition
- FDA’s partial recognition — and exactly what it excluded
- Whether you need to retest devices already cleared under the 2018 edition
- How biocompatibility documentation fits into your ISO 13485 QMS
- A quick audit checklist for your next document review
Table of Contents
👉 Start Here (Top Resources)
- ISO 10993-1:2025 — ANSI Webstore — the current edition of the core biocompatibility standard, available as an individual purchase or bundled with related parts of the series.
- ISO 10993 – Biological Evaluation of Medical Devices Package (bundled, ~45% off individual pricing) — the most cost-effective way to get ISO 10993-1, -5, -6, -7, and related parts together if you’re building out a complete biological evaluation file.
- BSI Group ISO 13485 Training — for teams that need to train reviewers or auditors on how biocompatibility evidence fits into the broader QMS, not just the lab side.
What Is Biocompatibility, and Why ISO 10993 Matters
Biocompatibility is the assessment of whether a device’s materials — and the way those materials contact the body — create an unacceptable biological risk. ISO 10993-1 is the standard that governs how you plan, justify, and document that biocompatibility risk assessment. It doesn’t hand you a checklist of tests to run blindly; it requires you to build a risk-based Biological Evaluation Plan (BEP) that considers the device’s materials, manufacturing processes, intended anatomical contact, and exposure duration.
That risk-based framing matters because it’s the same language FDA reviewers and notified bodies expect to see. A BEP that reads like a 2009-era test list, rather than a risk justification tied to ISO 14971, is a common source of review questions and additional information requests.
If you’re still building out your risk management process, our guide on risk management in medical devices under ISO 14971 covers the foundation ISO 10993-1 now leans on even more heavily than before.
The ISO 10993 Series at a Glance
ISO 10993-1 doesn’t stand alone — it’s the framework document for a series that covers specific test methods and evaluation categories.
| Part | Covers | Status Note |
|---|---|---|
| ISO 10993-1 | Overall evaluation and testing within a risk management process | Sixth edition (2025) now partially recognized by FDA |
| ISO 10993-5 | In vitro cytotoxicity | 2009 edition, still current |
| ISO 10993-6 | Local effects after implantation | Updated 2026 edition |
| ISO 10993-7 | Ethylene oxide sterilization residuals | Updated 2026 edition |
| ISO 10993-10 | Irritation and skin sensitization | 2021 edition |
| ISO 10993-12 | Sample preparation and reference materials | 2021 edition, amended 2025 |
| ISO 10993-17 | Toxicological risk assessment of device constituents | 2023 edition, amended 2025 |
| ISO 10993-18 | Chemical characterization of materials | 2020 edition, amended 2022 |
Most common finding: Manufacturers cite ISO 10993-5 or -10 correctly but leave the ISO 10993-1 reference in their design history file pointing to the 2018 edition without any documented rationale for why. If your BEP hasn’t been revisited since the 2025 edition published, that’s the first thing to check.
If your device is sterilized and you haven’t looked at how the 2026 edition of ISO 10993-7 interacts with your sterilization validation, our sterilization standards overview walks through ISO 11135, 11137, 17665, and 11607 alongside it.
What Changed in ISO 10993-1:2025
The sixth edition isn’t a light refresh. ISO’s technical committee reorganized the standard and changed its title to explicitly align with the ISO 14971 risk management framework. The practical changes:
- More detailed guidance on calculating exposure duration — including how to treat foreseeable misuse, such as a device used longer than its labeled duration.
- Expanded guidance on device characterization and biological hazard identification, intended to reduce reliance on generic test batteries.
- Terminology aligned with ISO 14971, so if your team already knows that standard, the 2025 edition should read more consistently — though NAMSA and other industry commentators note there isn’t yet a technical report equivalent to ISO/TR 24971 to guide interpretation of the new edition.
Here’s how the two editions compare on the points that matter most for your Biological Evaluation Plan:
| Topic | 2018 Edition | 2025 Edition |
|---|---|---|
| Risk Management Integration | Referenced ISO 14971 | More explicitly aligned throughout |
| Exposure Duration | Limited guidance | Expanded methodology for calculating duration, including foreseeable misuse |
| Biological Hazard Identification | Less detailed | Expanded guidance on device characterization and hazard identification |
| Risk Estimation | Different treatment | New Clause 6.9 (excluded by FDA) |
If you are preparing a Biological Evaluation Plan for a new device → start by confirming which edition your FDA reviewer or notified body expects to see referenced, since adoption isn’t uniform across regions. The EU has generally moved faster toward treating the 2025 edition as state of the art. Manufacturers should verify current adoption expectations directly with their notified body and applicable competent authorities, since implementation timing varies and is subject to change.
One shift worth flagging for regulatory teams building out a modern BEP: chemical characterization under ISO 10993-18 is playing a larger role than it used to. Rather than defaulting to a blanket biological test matrix for every device, more manufacturers are leaning on thorough chemical characterization data — extractables and leachables profiles, material composition analysis — to justify a narrower, risk-based testing strategy. ISO 10993-1:2025’s expanded hazard identification guidance reinforces this shift. A well-documented ISO 10993-18 characterization can reduce redundant biological testing, but only if the chemistry-driven rationale is documented clearly enough to withstand a reviewer’s scrutiny.
ISO 10993 FDA Recognition: What’s Excluded and Why
🔑 Key FDA Takeaway FDA recognizes ISO 10993-1:2025, but excludes:
- The “consumer products” language in Clause 6.5.11.3
- Clause 6.9 on biological risk estimation
Manufacturers should document alternative justification using FDA guidance and ISO 14971.
On May 25, 2026, FDA updated its Recognized Consensus Standards database (Recognition No. 2-313) to include ISO 10993-1:2025 — but not in full. Two specific exclusions matter for your submissions:
- The phrase “consumer products or” in Clause 6.5.11.3. This clause addresses low-risk, intact-skin-contacting devices. The standard allows manufacturers to point to a material’s history of safe use in consumer products as justification for reduced testing. FDA excluded this because it conflicts with Attachment G of its 2023 biocompatibility guidance, which defines specific materials with an accepted history of use — a consumer product history alone doesn’t automatically satisfy FDA’s expectations.
- Clause 6.9 on biological risk estimation. FDA determined this clause conflicts with the risk estimation approach already established in the FDA-recognized ISO 14971:2019. Sponsors can’t rely on Clause 6.9 to claim conformity in a submission.
If you are under customer or notified body pressure to update your BEP quickly → prioritize reviewing these two clauses first. They’re the specific areas where citing the 2025 edition alone won’t satisfy FDA, and you’ll need to document your justification through existing FDA guidance instead.
Partial recognition means you cannot submit a clean Declaration of Conformity to the full 2025 edition. Your submission documentation needs to call out the partial recognition explicitly and show how you’re addressing the excluded clauses — silence on this point is what generates additional information requests.
Do You Need to Retest Already-Cleared Devices?
This is the objection I hear most from teams looking at this update: does a new edition mean I have to redo my biocompatibility testing on devices that already have clearance?
No — not automatically. FDA’s recognition of a newer edition doesn’t retroactively invalidate data or clearances based on the 2018 edition. If you already hold clearance under the 2018 edition → you don’t need to retest existing devices. What you do need is a documented rationale, at your next design change or periodic review, for why your BEP still reflects sound risk management even though a newer edition exists. That’s a documentation and justification exercise, not a lab exercise.
Where this becomes a live issue is new submissions and significant design changes going forward — those are where reviewers will expect to see the current edition addressed.
Where Biocompatibility Fits Into Your ISO 13485 QMS
Biocompatibility data doesn’t live in isolation — it’s part of your design and development file under ISO 13485, and it feeds directly into your risk management file under ISO 14971. If your ISO 13485 documentation structure doesn’t have a clear place for biological evaluation plans, reports, and the rationale behind edition changes, that’s a gap worth closing before your next internal audit — not after a nonconformance is written.
This also connects to supplier controls. If a component supplier’s certificate of conformance references ISO 10993-1 by edition, your incoming inspection and supplier qualification process needs a mechanism to catch when that reference goes stale — the same principle covered in our guide on common mistakes in ISO 13485 QMS implementation.
And if you’re managing devices sold in both the US and EU, the edition-adoption gap between FDA and the EU regulatory framework is one more reason to keep your MDR vs ISO 13485 documentation aligned rather than treating them as separate tracks.
👉 If your biological evaluation documentation hasn’t been reviewed since the 2025 edition published, don’t wait for a finding to tell you. Check where your QMS documentation actually stands →
Quick Audit Checklist
✅ Confirm which edition of ISO 10993-1 your current BEP references, and whether that matches what your reviewer or notified body expects
✅ Check whether your device’s biocompatibility justification relies on Clause 6.5.11.3 (consumer product history) or Clause 6.9 (risk estimation) — both need alternative justification for FDA submissions
✅ Verify supplier certificates of conformance cite current standard editions, not stale references
✅ Confirm your risk management file cross-references your BEP consistently ✅ If your device is sterilized, check the 2026 editions of ISO 10993-6 and -7 against your current validation data ⚠️ Don’t assume “FDA recognized” means “fully accepted” — verify the Supplementary Information Sheet for any standard before citing it as a full Declaration of Conformity
FAQ
What is biocompatibility testing for medical devices?
Biocompatibility testing evaluates whether the materials in a medical device, and the way those materials contact the body, could cause an unacceptable biological response. It covers areas like cytotoxicity, sensitization, irritation, and systemic toxicity, selected based on the device’s contact type and duration.
What is ISO 10993-1, and do I need to comply with it?
ISO 10993-1 is the framework standard that governs how you plan and justify a biological evaluation within a risk management process. If your device contacts the body directly or indirectly, FDA and most global regulators expect your biocompatibility strategy to follow its structure, even where full conformity isn’t feasible.
What changed between ISO 10993-1:2018 and ISO 10993-1:2025?
The 2025 edition reorganized the standard to align more closely with ISO 14971, added detailed guidance on calculating exposure duration and identifying biological hazards, and updated terminology throughout.
Has the FDA recognized ISO 10993-1:2025?
Yes, as of May 25, 2026, but only partially. FDA excluded the “consumer products” language in Clause 6.5.11.3 and all of Clause 6.9 on biological risk estimation, both of which conflict with existing FDA guidance and the FDA-recognized ISO 14971:2019.
Do I need to retest devices already cleared under the 2018 edition?
No. Existing clearances aren’t invalidated by a newer edition. You do need a documented rationale for your current approach at your next design change or periodic review.
Which parts of the ISO 10993 series apply to my device?
That depends on your device’s contact type (surface, external communicating, or implant) and contact duration (limited, prolonged, or permanent). ISO 10993-1 provides the matrix for selecting relevant parts of the series based on those two factors. We’ll be covering that contact-duration matrix in detail in an upcoming guide.
Is ISO 10993 the same as ISO 13485?
No. ISO 13485 governs your overall quality management system for medical devices. ISO 10993 is a series specifically about biological evaluation, and its outputs — your BEP and test reports — become part of the design and development records your ISO 13485 QMS requires you to maintain.
Where do I purchase ISO 10993 standards?
Individual parts and bundled packages are available through the ANSI Webstore, which also serves international buyers and offers documents in multiple languages. The ISO.org catalog describes each part but is not the recommended purchase channel.
📥 Free Resources
- ISO 9001 Roadmap — step-by-step implementation guide for manufacturers building or improving a quality management system.
- Manufacturing Compliance Checklist — practical compliance reference covering key ISO, OSHA, and quality requirements for production environments.
- Supplier Quality Checklist — evaluation tool for assessing supplier quality controls and flow-down compliance before audits or new contracts.
- ISO 13485 Gap Assessment Checklist — free checklist for medical device manufacturers assessing their QMS against ISO 13485 requirements, including where biocompatibility documentation fits.
- AS9100 Rev D Gap Assessment Checklist — 74-item clause-by-clause checklist for aerospace suppliers assessing their QMS before certification.
Not Sure What to Do Next?
🔹 Still researching how the 2025 edition affects your device category? Start with our breakdown of risk management under ISO 14971 — biocompatibility evaluation doesn’t stand apart from it anymore.
🔹 Ready to check where your documentation actually stands? Run the ISO 13485 Gap Assessment Checklist before your next audit or submission, not after.
🔹 Need to purchase the current standard? ISO 10993-1:2025 — ANSI Webstore, or get the full biological evaluation package bundled at roughly 45% off individual pricing if you’re assembling multiple parts of the series. Use code CC2026 for an additional 5% off through December 31, 2026.
The Standards Navigator will keep tracking how FDA recognition evolves on this standard as updates are published.
Documentation Gaps Don’t Show Up Until Someone’s Looking For Them
Teams that treat biocompatibility as a one-time lab exercise are the ones caught off guard when a standard’s edition changes underneath them. Teams that treat it as a living part of their design and risk management file catch the mismatch at their next internal review, not during an FDA question round — and it’s usually a citation that didn’t keep up, not the underlying science, that stalls a submission.
The Standards Navigator tracks these regulatory shifts as they happen — not months later when the transition deadline is already close. If ISO 10993-1:2025 affects your device, this is a good window to revisit your documentation rationale while the timeline is still in your control.
👉 Get updates on medical device compliance and biocompatibility standard changes
👉 Be first to access new gap assessment checklists and documentation tools for ISO 13485 and ISO 14971
Subscribe below to stay ahead.
The Standards Navigator — Industrial Compliance. Clearly Explained.
