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General information about a standard, not medical advice and not a statement that any product complies with it.
Short answer
ISO 10993-3 is the part of the ISO 10993 series that gives strategies for evaluating genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity risks from medical devices. The current edition is ISO 10993-3:2026 (edition 4, published 6 August 2026). It replaces the 2014 edition and absorbs the genotoxicity test-method guidance that used to sit in ISO/TR 10993-33. It is an evaluation framework, not a pass/fail certificate.
What ISO 10993-3 covers
The full title of the 2026 edition is “Biological evaluation of medical devices – Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity.” Per the ISO committee page (ISO/TC 194, checked 2026-11-01), it applies when these effects are relevant to a device’s safety evaluation and takes a risk-based approach that considers intended use, exposure and biological interactions rather than a predefined list of tests. It also covers how chemical characterization and toxicological risk assessment can show whether testing is needed, and it provides evaluation and test methods where testing is appropriate. ISO describes the edition as a significant revision with more emphasis on evaluation than on testing alone.
In plain terms, the four endpoints are different questions. Genotoxicity concerns damage to genetic material; carcinogenicity concerns tumour formation; reproductive toxicity and developmental toxicity concern effects on reproduction and on development. This page does not describe individual test methods.
What changed from the 2014 edition
- Title and scope: the 2026 title names four endpoints: genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity.
- Withdrawn documents: ISO lists ISO 10993-3:2014 and ISO/TR 10993-33:2015 as withdrawn, and states that the new edition incorporates the genotoxicity test-method guidance previously in ISO/TR 10993-33.
- Emphasis: ISO describes more weight on evaluation (including chemical characterization and toxicological risk assessment) than on testing alone.
Practical consequence for document reviewers: a report that cites “ISO 10993-3:2014” or “ISO/TR 10993-33” refers to documents ISO now lists as withdrawn, so it is reasonable to ask which edition applies to the product and when the work was done.
Where Part 3 sits with Part 1 and FDA endpoint tables
Part 3 is one part of a series. The overall framework for deciding which biological effects to consider is covered in our guide to FDA guidance on biocompatibility and ISO 10993; other endpoints have their own parts, for example blood interaction testing (Part 4), local effects after implantation (Part 6), systemic toxicity (Part 11) and sample preparation and extracts (Part 12).
The FDA’s page “Biocompatibility Evaluation Endpoints by Device Category” (content current as of 7 September 2023, checked 2026-11-01) shows how the agency maps these endpoints to device categories:
| Endpoint | What the FDA page says |
|---|---|
| Genotoxicity | Marked in the tables for mucosal membrane surface devices, breached or compromised surface devices, external communicating devices (blood path, tissue/bone/dentin, circulating blood) and implant devices (tissue/bone, blood). The page also states: “For all devices used in extracorporeal circuits.” |
| Carcinogenicity | Marked in the tables for breached or compromised surface, external communicating and implant devices, but not for mucosal membrane or intact skin devices; the page gives no separate narrative on it. |
| Reproductive/developmental toxicity | “Should be addressed for novel materials, materials with a known reproductive or developmental toxicity.” |
That FDA page dates from before the 2026 ISO edition, so it does not describe how the agency treats the new edition. Treat the FDA tables and the ISO standard as two separate documents.
What to ask a supplier for
These are questions to put to a supplier or to check in a biological evaluation file. Answers are claims to be read, not proof of compliance.
- Which edition of ISO 10993-3 (and which other parts) does the evaluation cite, and what is the date of the work?
- Were genotoxicity, carcinogenicity, and reproductive and developmental toxicity each addressed, or is a written justification given for why an endpoint was not applicable?
- Does the device category and contact type in the report match the product as sold (for example, implant versus external communicating)?
- Is there a chemical characterization or toxicological risk assessment, and which materials and device configuration did it cover?
- What is the scope of any test report: which sample, which device version, and who issued it?
- For a novel material, how is reproductive and developmental toxicity handled, given the FDA page’s wording above?
For the related quality-system background, see our explainer on ISO 13485 medical device quality management systems.
Common misunderstandings
Genotoxicity and carcinogenicity are the same thing
They are listed as separate endpoints in both the ISO title and the FDA tables. Genotoxicity is about effects on genetic material; carcinogenicity is about tumour formation.
Part 3 is a certificate
The standard gives evaluation strategies. ISO describes a risk-based approach, not a predefined test list, so citing the standard does not by itself say what was concluded about a given device.
Every device needs every endpoint
The ISO page says the standard applies when these effects are relevant to the device’s safety evaluation, and the FDA page ties the endpoints to specific device categories and, for reproductive and developmental toxicity, to novel or known-concern materials.
FAQ
What is ISO 10993-3?
It is Part 3 of the ISO 10993 biological evaluation series, covering evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity for medical devices. The current edition is ISO 10993-3:2026.
What does ISO 10993 genotoxicity testing mean?
Genotoxicity is one of the endpoints in Part 3. The 2026 edition incorporates genotoxicity test-method guidance that was previously in ISO/TR 10993-33, which ISO lists as withdrawn. This page does not describe individual methods.
Is ISO 10993-3:2014 still current?
ISO lists ISO 10993-3:2014 as withdrawn, replaced by the 2026 edition.
When does the FDA expect genotoxicity to be considered?
The FDA endpoint tables mark genotoxicity for mucosal membrane, breached or compromised surface, external communicating and implant categories, and carcinogenicity for breached or compromised surface, external communicating and implant categories (not mucosal membrane or intact skin), and state genotoxicity applies to all devices used in extracorporeal circuits (page current as of 7 September 2023).
Sources
- ISO, “ISO 10993-3:2026” (ISO/TC 194 committee page): committee.iso.org/standard/88199.html, checked 2026-11-01.
- U.S. FDA, “Biocompatibility Evaluation Endpoints by Device Category”: fda.gov biocompatibility endpoints by device category, content current as of 2023-09-07, checked 2026-11-01.
