Category: ISO 15223

ISO 10993 Contact Duration Matrix- How to Select Tests (2026 Guide)

ISO 10993-1:2025 retired the old Table A.1 checklist approach to biocompatibility testing. This guide explains the current contact duration categories, how total exposure period is calculated for reusable devices, and which biological endpoints apply — including FDA’s partial recognition of the new edition.

ISO 10993 Contact Duration Matrix and Biological Endpoint Selection Explained

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The Matrix Changed. If Your Biological Evaluation Plan Still Reads Like 2018, You Have a Gap

Table A.1 is gone. For seven years, biological evaluation plans were built around a single grid in Annex A of ISO 10993-1:2018 — cross-reference device category and contact duration, check the boxes, done. That table has been retired. ISO 10993-1:2025, published November 18, 2025, split it into four separate tables and rebuilt the exposure-duration logic underneath them.

ISO 10993-1:2025 is the international standard that guides biocompatibility and biological evaluation of medical devices using a risk-based framework, replacing the prescriptive checklist approach of the 2018 edition.

If your BEP still cites the 2018 ISO 10993 contact duration matrix, or if you categorized a reusable device’s contact duration based on a single use rather than total exposure period, you may already be carrying a documentation gap — one that surfaces exactly when a reviewer or notified body opens your file.

Regulatory affairs teams are asking a narrower question than “what is ISO 10993”: which biological endpoints does this specific device trigger under the current framework, and why. That’s what this guide walks through.

I’ve sat across the table from an auditor reviewing a biological evaluation plan where the contact duration category didn’t match the device’s actual use pattern — a reusable component that looked like “limited” contact on paper but was accumulating well past 24 hours across a single patient’s treatment course. The documentation existed. The categorization logic behind it didn’t hold up. That’s the gap this guide is built to close before it becomes a finding.

👉 Before you finalize your next biological evaluation plan, run it against a structured QMS gap check first. Get the free ISO 13485 Gap Assessment Checklist and confirm your documentation controls support the categorization decisions your BEP depends on.

In This Guide

  • What changed in the ISO 10993-1:2025 evaluation matrix and why Table A.1 was retired
  • The current contact duration categories and how “total exposure period” is calculated
  • How to categorize daily contact, intermittent contact, and reusable devices correctly
  • Which biological endpoints apply to each contact duration and body-contact combination
  • What FDA’s partial recognition of ISO 10993-1:2025 means for your submission
  • Common categorization mistakes that trigger additional testing requirements
  • Where to buy the current standard and where to get ISO 13485-aligned training

👉 Start Here (Top Resources)

  • ISO 10993-1:2025 — ANSI Webstore — the current edition, direct from the accredited source. Use code CC2026 for 5% off. (Eric: insert the exact ANSI product link for ISO 10993-1:2025 here.)
  • If you’re weighing whether to buy standards individually or as a set, the ANSI bundle option is worth checking before you purchase the 10993 series piece by piece.
  • ISO 13485 Training — BSI Group — for teams building biological evaluation competency into a certified QMS.
  • ISO Training Courses — ISOQAR — a second accredited training option worth comparing against BSI on schedule and price.
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Why the Evaluation Matrix Was Restructured

Under ISO 10993-1:2018, Annex A Table A.1 organized devices by body contact category — surface, external communicating, implant — crossed with three contact duration bands, and listed an “X” for every biological endpoint a reviewer might expect to see addressed. Industry insiders came to call it the “Table A.1 mentality”: manufacturers treated the X’s as a mandatory checklist rather than a starting point for risk-based justification. Tests got run because they appeared in a cell, not because a documented risk assessment called for them.

ISO 10993-1:2025 splits that single table into four separate tables, each tied to a specific evaluation context, and embeds the framework more tightly into the ISO 14971 risk management process. The standard now expects a Biological Evaluation Plan built on the device’s actual risk profile — chemical characterization, materials history, intended use, contact pattern — with the tables used to check completeness, not generate a test order.

Most common finding: biological evaluation plans that cite “Table A.1” by name, or that list endpoints without a documented rationale tied to the device’s specific exposure profile. Under the current standard, that’s a gap a reviewer will flag.

If you are still building your first BEP for a device entering the medical device space, start with what the supplier controls requirements under ISO 13485 expect from your materials documentation — biological evaluation depends heavily on having reliable supplier and materials data before you ever get to a test matrix.

Contact Duration Categories, Defined

The three contact duration categories are unchanged in name but recalculated in practice:

CategoryCumulative ContactTypical Devices
LimitedUp to 24 hours totalDiagnostic swabs, single-use syringes, short procedural instruments
ProlongedMore than 24 hours, up to 30 days totalWound dressings changed over several weeks, indwelling catheters (short-term), orthodontic devices
Long-term / PermanentMore than 30 days totalImplants, permanent orthopedic hardware, long-term catheters

The category itself hasn’t moved. What changed is how you calculate “total contact” for a device that isn’t used in one continuous stretch — and that recalculation is where most categorization errors happen.

If you are evaluating a device used in short, repeated sessions → don’t categorize based on a single session length. The standard expects you to sum all contact time across the device’s full use pattern before assigning a category.

Daily Contact vs. Intermittent Contact

Comparison infographic explaining daily contact and intermittent contact under ISO 10993-1:2025 for biological evaluation of medical devices.
ISO 10993-1:2025 distinguishes between daily and intermittent contact when determining cumulative exposure for biological evaluation.

ISO 10993-1:2025 formalizes two exposure patterns that the 2018 edition handled inconsistently:

  • Daily contact — the device touches the body every day, for any portion of a day, across a defined treatment course. Total exposure is counted as calendar days from first use to last use (or replacement) on a single patient.
  • Intermittent contact — use with at least 24 hours between consecutive contacts. This is treated as repeated use of the same device, or a replacement device, under evaluation.

A wound contact layer changed daily over three weeks is the textbook example: under the 2018 edition, each dressing change might have been assessed as its own “limited” exposure. Under the current standard, the 21 cumulative contact days push the device into prolonged territory — and that shift can add endpoints your original evaluation never considered.

If you are re-evaluating a device that was cleared under the 2018 categorization logic → don’t assume your existing category still holds. Run the total exposure period calculation against the current definitions before you finalize anything for a new submission.

Reusable Devices and Total Exposure Period

Reusable devices are now categorized based on cumulative contact time for a single patient across the device’s full use pattern — not the duration of any one use, and not a multi-patient device service-life total. A reusable surgical instrument sterilized and reused across a procedure series looks brief per individual contact, but the relevant figure is how many total contact days that one patient accumulates across their treatment course, including reasonably foreseeable misuse such as use beyond the labeled reprocessing cycle count.

Bioaccumulation is a related but less settled consideration. FDA’s Supplementary Information Sheet for ISO 10993-1:2025 (Recognition No. 2-313) notes that ISO/TC 194 Working Group 1 is still developing technical reports specifically addressing bioaccumulation, intermittent contact, and reasonably foreseeable misuse. In practice: if chemical characterization data — extractables and leachables — raises a bioaccumulation concern, that finding should inform your risk assessment and may support escalating the device’s category, but document it as a risk-based judgment rather than treating it as a fixed clause requirement until the supporting technical reports are finalized.

For teams managing this inside a certified QMS, it’s a judgment call that needs to trace back to a documented decision — not a verbal risk call made in a meeting. Clause 9 of ISO 10993-1:2025 requires that biological evaluations be planned, conducted, and reported by competent personnel, with the evaluation report documenting the rationale behind risk decisions like this one. The CAPA requirements under ISO 13485 apply just as much to a categorization correction as to a nonconformance on the shop floor.

Flowchart explaining cumulative single-patient exposure for reusable medical devices under ISO 10993-1:2025.
Reusable medical devices are categorized using cumulative single-patient exposure rather than the duration of a single procedure.

Mapping Contact Category to Biological Endpoints

The biological effects under consideration haven’t fundamentally changed — cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation effects, and hemocompatibility remain the backbone, and ISO 10993-1 remains a risk-based framework, not a mandatory testing checklist. What changed is the scope of consideration required, particularly for genotoxicity:

Contact DurationBody ContactGenotoxicity Consideration
LimitedAnyCase-by-case, per risk assessment
ProlongedAll tissues except intact skinGenerally expected to be addressed per Tables 2–4 and Clause 6.5.7
Long-term / PermanentAll tissues except intact skinGenerally expected to be addressed per Tables 2–4 and Clause 6.5.7

Under the 2018 edition, genotoxicity was consistently expected for implants and long-term tissue contact, but inconsistently applied to prolonged-contact devices touching mucosal membranes or breached surfaces. ISO 10993-1:2025 narrows that inconsistency: per Tables 2–4 and Clause 6.5.7, any device requiring systemic toxicity evaluation due to prolonged or long-term contact is now generally expected to address genotoxicity as well, intact skin excepted — though this remains a risk assessment expectation to be justified within your Biological Evaluation Plan, not an automatic in vivo test order. Where existing data (toxicological risk assessment under ISO 10993-17, chemical characterization, or literature) already addresses the risk adequately, testing may not be necessary. Carcinogenicity consideration was similarly extended for long-term contact with intact mucosal membranes.

Worth flagging directly: FDA’s Supplementary Information Sheet for ISO 10993-1:2025 (Recognition No. 2-313) identifies a genuine discrepancy here. ISO 10993-1:2025 lists genotoxicity as an endpoint for consideration across all prolonged-contact device categories, while FDA’s own Table A.1 (Attachment A of its 2023 Biocompatibility Guidance) limits the genotoxicity endpoint to implanted devices, externally communicating devices with tissue/bone/dentin contact, and externally communicating devices with circulating blood contact. For a U.S. submission, don’t assume the broader ISO scope automatically controls — confirm which framework your reviewer expects you to follow.

Most common finding: biological evaluation plans for prolonged-contact mucosal devices that address systemic toxicity but don’t document a genotoxicity rationale one way or the other — an omission that was easier to overlook under the 2018 matrix and is more likely to draw a question under the current one.

If your device’s evaluation also touches sterilization residuals, review our sterilization standards overview — ethylene oxide and other sterilization residues are a recurring driver of chemical characterization findings that reshape a biological evaluation.

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FDA’s Partial Recognition — What’s Excluded

FDA recognized ISO 10993-1:2025 on May 25, 2026 (Recognition No. 2-313 in FDA’s Recognized Consensus Standards database), but the recognition is partial, not full. Two carve-outs from the Supplementary Information Sheet matter for submission strategy:

  • The phrase “consumer products or” in Clause 6.5.11.3 (Low Risk Intact Skin Contacting Medical Devices) is not recognized — FDA states it conflicts with Attachment G of its 2023 biocompatibility guidance, which limits which historical-use materials qualify for reduced testing on skin-contacting devices.
  • Clause 6.9, Biological risk estimation, is not recognized — FDA holds it conflicts with the risk estimation approach already established under ISO 14971:2019, which FDA separately recognizes.

If you are preparing a 510(k), PMA, or De Novo submission → you cannot submit a full Declaration of Conformity without addressing these two exclusions directly, and the genotoxicity discrepancy above is a separate, related point worth raising with your reviewer proactively. Cite the standard, but demonstrate compliance for the excluded clauses through FDA’s existing biocompatibility guidance rather than assuming automatic alignment. FDA’s recognized standard entry and Supplementary Information Sheet have already been updated since publication — verify the current version directly against FDA’s Recognized Consensus Standards database before finalizing any submission.

For the broader shift this represents in medical device documentation expectations, see our breakdown of validation and verification requirements under ISO 13485 and the FDA QMSR.

Common Categorization Mistakes

Infographic highlighting common ISO 10993 biological evaluation and contact duration categorization mistakes for medical device manufacturers.
Many ISO 10993 audit findings result from incorrect categorization logic or incomplete biological evaluation documentation rather than testing failures.

⚠️ Categorizing by single-use duration instead of cumulative single-patient exposure. The single most common error on reusable and repeat-use devices — it understates the contact category more often than it overstates it.

⚠️ Citing “Table A.1” in a current BEP. A reference to the old table structure is a documentation red flag on its own, independent of whether the underlying science holds up.

⚠️ Assuming genotoxicity doesn’t need to be addressed for prolonged mucosal contact. Teams working from older templates default to a 2018-era endpoint list and skip documenting a rationale either way — under the current tables, that gap is more likely to draw a question.

⚠️ Assuming FDA recognition is full, or that ISO and FDA genotoxicity scope match. Building a submission strategy around blanket alignment, without addressing the excluded clauses and the genotoxicity scope discrepancy, invites an avoidable deficiency letter.

If you are unsure whether existing biological evaluation plans need revisiting → they don’t automatically require retesting, but ISO 10993-1:2025 does expect a documented review confirming prior categorization and endpoint rationale still hold under current definitions.

Quick Audit Checklist

✅ Contact duration category calculated from cumulative single-patient exposure, not single-use duration
✅ Reusable/repeat-use devices assessed for total contact days for one patient across their treatment course
✅ Genotoxicity rationale documented for prolonged/long-term contact except intact skin, per Tables 2–4 and Clause 6.5.7
✅ Biological Evaluation Plan references current ISO 10993-1:2025 structure, not legacy Table A.1
✅ FDA submission strategy accounts for the two partially-recognized clauses and the genotoxicity scope discrepancy
✅ Bioaccumulation signals from chemical characterization data reviewed and documented as a risk judgment, not assumed to require automatic escalation ✅ Existing (pre-2025) biological evaluations documented as reviewed against current definitions

FAQ

Does ISO 10993-1:2025 require me to retest devices already on the market?

No. The standard doesn’t mandate automatic retesting for devices with an acceptable safety history. It does expect a documented review confirming prior categorization and evaluation still hold, and an update if a Clause 10 production change triggers a re-review.

Is ISO 10993-1:2018 still valid to use?

FDA’s recognized standards database is the authority for U.S. submissions — verify current recognition status before relying on either edition. For new evaluation plans, aligning with the 2025 edition is the safer long-term position.

What’s the difference between “prolonged” and “long-term” contact?

Prolonged contact covers cumulative contact exceeding 24 hours but not exceeding 30 days. Long-term (permanent) contact covers cumulative contact exceeding 30 days, driven by total exposure period rather than packaging or labeling.

Does the 2025 edition apply to devices regulated under the EU MDR?

It’s generally treated as state of the art for MDR purposes, but grace periods and notified body expectations vary — confirm directly with your notified body.

Is genotoxicity testing now mandatory for every prolonged-contact device?

Not automatically. Per Tables 2–4 and Clause 6.5.7, genotoxicity is generally expected to be addressed through risk assessment for prolonged and long-term contact with all tissues except intact skin — but “addressed” can mean justified through existing toxicological or chemical characterization data, not necessarily new in vivo testing. Note also that FDA’s own Table A.1 applies genotoxicity more narrowly than ISO does, so confirm which framework governs your specific submission.

Do I need a new Biological Evaluation Plan for every device?

No blanket requirement to start over. Most manufacturers can update an existing BEP to reflect current categorization logic and endpoint scope, provided the underlying risk assessment and chemical characterization data are still valid.

How does ISO 14971 relate to my biological evaluation?

ISO 10993-1:2025 is now more tightly embedded in the ISO 14971 risk management process. See our guide on risk management in medical devices under ISO 14971 for how that framework applies.

Where do I buy the current edition of ISO 10993-1?

Through an authorized reseller such as the ANSI Webstore, which also serves international buyers and offers standards in multiple languages. ISO 10993-1:2025 — ANSI Webstore — Coupon code CC2026 applies through December 31, 2026.

📥 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

Not Sure What to Do Next?

🔹 Still researching how the current standard applies to your device? Read our Biocompatibility Standards Overview for the full picture before you build a test matrix.

🔹 Ready to build or update your Biological Evaluation Plan? Download the ISO 13485 Gap Assessment Checklist and confirm your documentation controls support the categorization decisions you’re about to make.

🔹 Need to purchase the current standard? ISO 10993-1:2025 — ANSI Webstore — code CC2026 takes 5% off, and international buyers can access the standard in multiple languages through the same source.

The Standard Changed. Your Categorization Logic Should Too.

Table A.1 was a shortcut, and shortcuts age out. ISO 10993-1:2025 asks for a defensible, risk-based answer instead of a checked box — and that’s a better position to defend in front of a reviewer regardless of which edition your notified body is citing this quarter. The Standards Navigator will keep tracking how FDA recognition and international adoption evolve as this transition plays out.

Don’t Let a Reviewer Find the Gap First

Most biological evaluation gaps don’t get caught in your own review — they get caught by a notified body auditor or an FDA reviewer, months after the plan was finalized. Manufacturers who treat contact duration categorization as a one-time exercise tend to carry that risk forward through every product change. Manufacturers who build a documented, repeatable categorization process into their QMS catch the drift before it becomes a submission delay.

The Standards Navigator tracks ISO 10993, ISO 13485, and the broader medical device compliance landscape as it evolves — including regulatory recognition changes like FDA’s partial recognition of ISO 10993-1:2025.

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Biocompatibility Standards Explained: ISO 10993 Requirements for Medical Devices in 2026

This guide breaks down the ISO 10993 series and the sixth edition of ISO 10993-1, published in November 2025. It covers FDA’s partial recognition of the new edition in May 2026, the two clauses the agency excluded, and whether manufacturers need to revisit biological evaluation plans for devices already cleared.

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

👉 Start Here (Top Resources)

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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

Infographic showing the ISO 10993 series for biological evaluation of medical devices, including ISO 10993-1, -5, -6, -7, -10, -12, -17, and -18.
The ISO 10993 series consists of multiple standards that together form a complete biological evaluation framework for medical devices.

ISO 10993-1 doesn’t stand alone — it’s the framework document for a series that covers specific test methods and evaluation categories.

PartCoversStatus Note
ISO 10993-1Overall evaluation and testing within a risk management processSixth edition (2025) now partially recognized by FDA
ISO 10993-5In vitro cytotoxicity2009 edition, still current
ISO 10993-6Local effects after implantationUpdated 2026 edition
ISO 10993-7Ethylene oxide sterilization residualsUpdated 2026 edition
ISO 10993-10Irritation and skin sensitization2021 edition
ISO 10993-12Sample preparation and reference materials2021 edition, amended 2025
ISO 10993-17Toxicological risk assessment of device constituents2023 edition, amended 2025
ISO 10993-18Chemical characterization of materials2020 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:

Topic2018 Edition2025 Edition
Risk Management IntegrationReferenced ISO 14971More explicitly aligned throughout
Exposure DurationLimited guidanceExpanded methodology for calculating duration, including foreseeable misuse
Biological Hazard IdentificationLess detailedExpanded guidance on device characterization and hazard identification
Risk EstimationDifferent treatmentNew 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.

Comparison graphic showing the major differences between ISO 10993-1:2018 and ISO 10993-1:2025 for biological evaluation of medical devices.
The 2025 edition places greater emphasis on risk management integration, biological hazard identification, and exposure assessment.
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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:

  1. 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.
  2. 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.

Workflow illustrating FDA partial recognition of ISO 10993-1:2025 and the documentation required for excluded clauses during medical device submissions.
FDA recognizes ISO 10993-1:2025 with specific exclusions, requiring manufacturers to document alternative regulatory justifications.

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

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ISO 15223 Symbols Overview: What Every Medical Device Label Actually Means (2026 Guide)

ISO 15223-1:2021 governs the pictograms on every medical device label. This guide breaks down the seven symbol categories, key reference symbols, and the 2026 EU REP amendment — including exact transition deadlines under MDR and IVDR.

A regulatory affairs guide to the pictograms your labels are required to carry — and the 2026 EU REP symbol change you need to track

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.

This article is for general informational purposes and is not regulatory advice. Manufacturers should verify symbol requirements against the current version of ISO 15223-1 and applicable regulatory guidance.

ISO 15223-1:2021 is the internationally recognized standard that defines symbols used on medical device labels, packaging, and accompanying information to communicate critical safety and regulatory information without language-specific text.

The ISO 15223 Symbols That Trigger a Labeling Recall

A single wrong pictogram on a device label isn’t a cosmetic problem. It’s a labeling nonconformance that can hold up a shipment, trigger a Notified Body finding, or in the worst case, force a recall.

ISO 15223-1:2021 is the standard behind nearly every symbol on a medical device label — manufacturer, batch code, sterile, use-by date, and dozens more. It’s not optional guidance. It’s the harmonized reference regulatory affairs teams are expected to follow for CE marking label symbols, and it just changed in a way that affects almost every CE-marked device on the market.

From the floor: I’ve reviewed label proofs where a well-meaning graphics team swapped in an old sterilization icon because it “looked close enough” to what the previous product used. It wasn’t the same symbol, and it wasn’t accompanied by the batch reference the standard requires next to it. Having reviewed manufacturing and quality documentation across multiple industrial environments, I’ve repeatedly seen labeling errors originate not from misunderstanding the requirements, but from uncontrolled template reuse. That kind of small mismatch is exactly what a label review process is supposed to catch before it reaches a Notified Body’s desk — not after.

👉 Before your next label revision goes to print, confirm every symbol still matches current guidance. Most labeling nonconformances aren’t due to unfamiliarity with the standard — they’re due to reusing an old label file without checking what changed. Get the ISO 13485 Gap Assessment Checklist and confirm your revision management process is catching this before a reviewer does.

In This Guide

  • What ISO 15223-1:2021 actually covers and why it’s harmonized under MDR/IVDR
  • The seven symbol categories and what each one communicates
  • The 2026 EU REP symbol change — what changed, when, and what it means for your labels
  • Common labeling mistakes that surface in document reviews
  • FAQ

👉 Start Here

Download Standards

What Is ISO 15223-1:2021?

ISO 15223-1:2021, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements, is now in its fourth edition. It defines the standardized pictograms manufacturers use on labels, packaging, and accompanying documentation so a device can be understood across languages and markets without translation.

It was harmonized under both EU MDR and EU IVDR in January 2022 — one of a relatively small number of standards to hold that status — which means using it correctly carries a presumption of conformity with the corresponding MDR/IVDR labeling requirements. A companion standard, ISO 15223-2, covers how new symbols get developed, selected, and validated when nothing in the existing library fits.

Because ISO 15223-1 is harmonized under MDR and IVDR, proper symbol usage can support a manufacturer’s demonstration of conformity with labeling requirements. In practice, auditors and Notified Bodies routinely review symbol usage as part of labeling assessments — this isn’t a peripheral checklist item, it’s one of the more commonly reviewed elements of a technical file.

Why Manufacturers Use Symbols

Medical devices are distributed across multiple countries and languages. Standardized symbols reduce the need for translated label text while helping manufacturers meet labeling requirements consistently across global markets. A single symbol library means the same pictogram carries the same meaning whether a device ships to Germany, Japan, or Brazil — without a separate translated label for each market.

ISO 15223-1 Medical Device Symbols Explained

ISO 15223-1 organizes its medical device label symbols into seven functional groups:

  • Manufacturing — manufacturer identity, date of manufacture, country of manufacture
  • Storage — temperature limits, humidity limits, keep dry, keep away from sunlight
  • Safe use — single use, do not use if damaged, consult instructions for use
  • Sterility — sterile, sterilization method, do not resterilize
  • IVD-specific — symbols unique to in vitro diagnostic devices
  • Transfusion/infusion — symbols for blood and infusion-related devices
  • Other — symbols that don’t fit cleanly into the categories above but are still standardized

Every symbol in the standard comes with a defined title, a description of what it communicates, and any accompanying information it must be paired with — a batch code symbol without an actual batch number next to it isn’t a valid use of the symbol.

Most Common ISO 15223-1 Medical Device Symbols

Infographic illustrating the most common ISO 15223 symbols for medical device labeling, including manufacturer, LOT, REF, serial number, sterile, use-by date, consult instructions for use, and keep dry.
The most frequently used ISO 15223-1 symbols help communicate critical manufacturing, traceability, sterility, and safety information on medical device labels worldwide.

The following symbols represent some of the most commonly encountered markings in medical device labeling. This is not a complete list, but these symbols appear on a significant percentage of devices entering regulated markets.

Symbol TitleClauseWhat It Communicates
Manufacturer5.1.1Identifies the legal manufacturer; name and address must accompany it
Date of manufacture5.1.3The date the device was produced
Use-by date5.1.4The date after which the device should not be used
Batch code (LOT)5.1.5Identifies the manufacturing batch or lot
Catalogue number (REF)5.1.6The manufacturer’s catalogue/model number
Serial number (SN)5.1.7Identifies a specific individual device
Importer5.1.8Identifies the entity importing the device into a given market
Sterile5.2.1Device has been through a sterilization process
Do not resterilize—Device is not to be resterilized after use
Do not use if package damaged—Consult instructions for use if packaging integrity is compromised
Single use—Device is intended for one use only

This is a reference sample, not the full symbol library — the standard runs well beyond these. For the complete set of ISO 15223 symbol meanings, always validate current symbol usage against the live ISO document rather than a saved reference sheet, since amendments do get issued.

Download IEC Standards

The 2026 EU REP Symbol Change

The most consequential update to this standard in years just took effect. Amendment EN ISO 15223-1:2021/A1:2025 replaces the long-standing “EC REP” symbol for a medical device’s authorized representative in the EU with a new “EU REP” symbol, and introduces a generic “XX REP” framework where “XX” is swapped for the applicable country or jurisdiction code.

The change was requested by the European Commission in May 2024, specifically to eliminate confusion between “EC” as a regulatory abbreviation and “EC” as the ISO 3166-1 country code for Ecuador. ISO adopted the amendment in March 2025, and it was formally harmonized into the Official Journal of the European Union on June 17, 2026, through Commission Implementing Decision (EU) 2026/1231 (amending MDR-side Decision 2021/1182) and Commission Implementing Decision (EU) 2026/1313 (amending IVDR-side Decision 2021/1195).

The European Commission has been explicit that this is a purely editorial change — it does not alter the authorized representative symbol’s role, responsibilities, or the device’s safety or performance profile in any way. This amendment is now one of the more consequential updates among the current round of MDR harmonized standards, given how widely the symbol appears across the CE-marked device population.

Timeline infographic illustrating the transition from the EC REP symbol to the EU REP symbol under ISO 15223-1:2021 Amendment A1:2025, including key regulatory milestones through 2031.
The transition from EC REP to EU REP includes a five-year coexistence period, allowing manufacturers to update labeling during normal revision cycles before the 2031 deadline.

👉 Planning an upcoming label revision? Download the ISO 13485 Gap Assessment Checklist to verify your revision management process is capturing changes to standards before they become audit findings.

Do You Need to Update Your Labels Right Now?

The most common objection: “Do we need to reprint every label immediately?”

No. The Commission built in a five-year coexistence period. Manufacturers may continue using the legacy “EC REP” symbol under the original EN ISO 15223-1:2021, or transition to the new “EU REP” symbol under the amendment — both are valid during this window. The old standard’s reference isn’t withdrawn until June 15, 2031 under MDR and June 17, 2031 under IVDR. After those dates, only “EU REP” confers presumption of conformity.

In practice, this means:

  • If you are about to run a new label print or design revision anyway → use the new EU REP symbol now rather than reprinting again later.
  • If your current labels are compliant and not due for revision → there is no requirement to act immediately; plan the change into your next scheduled label update.
  • If you have a Notified Body conformity review coming up → confirm with them directly whether they expect the new symbol in your current submission, since individual Notified Body expectations can vary during a transition window.

Common ISO 15223 Labeling Nonconformances

Most common finding: inconsistent symbol usage across packaging levels — the outer carton uses one version of the authorized representative symbol while the inner unit label uses another, with no documented rationale for the difference.

Other recurring issues: sterilization method symbols that don’t match the actual method used (ethylene oxide vs. irradiation vs. steam each has a distinct symbol); batch code or serial number symbols placed on a label without the actual batch or serial data adjacent to them; and reused label templates that carry forward a superseded symbol simply because nobody flagged the amendment during change control review.

⚠️ None of these mistakes require a new symbol library to fix — they require a label governance process that actually checks current symbol validity before a label goes to print, not just before the first label was ever approved.

Quick Reference Checklist

Professional infographic showing a medical device label review checklist based on ISO 15223-1, including symbol verification, sterilization validation, traceability, packaging consistency, and revision control.
A structured label review process helps manufacturers verify ISO 15223-1 symbol compliance before medical devices move into production or distribution.

✅ Current label set reviewed against the live ISO 15223-1:2021 symbol library ✅ Sterilization method symbol matches the actual method used
✅ Batch code, catalogue number, and serial number symbols paired with real data
✅ EU REP transition plan documented, even if no immediate label change is required
✅ Packaging levels (outer carton, inner unit, IFU) checked for symbol consistency
✅ Change control process flags standard amendments, not just initial approvals

FAQ

What is ISO 15223-1:2021?

It’s the international standard defining the pictograms used on medical device labels, packaging, and accompanying information — covering everything from manufacturer identity to sterilization method. It’s currently in its fourth edition and harmonized under both EU MDR and IVDR.

Do I have to switch to the EU REP symbol immediately?

No. The European Commission built in a five-year coexistence period. The legacy EC REP symbol remains valid until the original standard’s reference is withdrawn — June 15, 2031 under MDR and June 17, 2031 under IVDR.

Is the EU REP change a safety-related update?

No. The Commission has described it as a purely editorial change, made to eliminate confusion with Ecuador’s ISO 3166-1 country code. It does not change the authorized representative’s role or responsibilities.

What’s the difference between ISO 15223-1 and ISO 15223-2?

Part 1 defines the actual symbol library and how symbols must be used. Part 2 covers the process for developing, selecting, and validating a new symbol when nothing in the existing library fits a specific need.

Does every medical device need every symbol in the standard?

No. Which symbols apply depends on the device — a non-sterile reusable device won’t carry sterilization symbols, for example. The standard defines what each symbol means and how to use it correctly; it doesn’t mandate that every device carry every symbol.

What’s the most common labeling mistake regulatory teams miss?

Inconsistent symbol usage across packaging levels — using an updated symbol on one layer of packaging while an older version persists on another, usually because a label template wasn’t fully reviewed during a revision.

Where can I find the actual symbol library?

ISO 15223-1:2021 and its companion ISO 15223-2 are both available for purchase through ANSI Webstore, either individually or as a combined package.

Should my Notified Body confirm which symbol version they expect?

During the transition period, manufacturers should confirm expectations directly with their Notified Body, particularly if a labeling review or conformity assessment is already underway.

📥 Free Resources

  • ISO 13485 Gap Assessment Checklist — free checklist for medical device manufacturers assessing their QMS against ISO 13485 requirements, including the revision management processes that keep labeling current.
  • ISO 9001 Roadmap — step-by-step implementation guide for manufacturers building or improving a quality management system from the ground up.
  • Manufacturing Compliance Checklist — practical compliance reference covering key ISO, OSHA, and quality requirements across production environments.

Not Sure What to Do Next?

🔹 Still researching how labeling symbols fit into your broader QMS? Start with ISO 13485 Documentation Requirements and Common Mistakes in ISO 13485 QMS to see where document control connects to labeling accuracy.

🔹 Ready to review your current label set? Check it against Sterilization Standards Overview and UDI Requirements Explained — both cover label-adjacent requirements that pair directly with ISO 15223-1 symbols.

🔹 Need to purchase the standard itself? Get the ISO 15223 Symbols Package from ANSI Webstore — available individually or bundled with Part 2, with code CC2026 for 5% off through December 31, 2026.

Symbols look like a small detail until one of them is wrong on a printed label already in circulation. The Standards Navigator will keep tracking the EU REP transition and any further ISO 15223 amendments as they’re published.

Don’t Let a Symbol Be the Reason for a Finding

Labeling nonconformances are some of the most avoidable findings in a Notified Body review — the standard is published, the symbols are defined, and the fix is almost always a revision management gap rather than a technical one.

The Standards Navigator tracks ISO 15223 amendments, MDR/IVDR labeling requirements, and medical device documentation standards so your labels don’t fall out of step with a standard that changed while nobody was watching.

👉 Get updates on ISO 15223, MDR/IVDR labeling changes, and medical device documentation requirements as they happen
👉 Be first to access new gap assessment tools built for medical device regulatory affairs teams

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The Standards Navigator — Industrial Compliance. Clearly Explained.