ISO 10993 is an international standard series for the biological evaluation of medical devices. It sets out a risk-based framework for deciding what biological testing a device needs, based on how it contacts the body and for how long, rather than one fixed test battery for every device. FDA references ISO 10993-1 in its own biocompatibility guidance and recognizes parts of the series as consensus standards.
Manufacturers, test labs, and regulators use ISO 10993 as the common framework for answering one question: can this device's materials cause an unacceptable biological response in the body it contacts. Its structure is built around a risk-based evaluation rather than a mandatory checklist, which is often the part teams encountering it for the first time misunderstand.
Parts Most Relevant to an FDA Submission
| Part | Subject |
|---|---|
| ISO 10993-1 | The framework part: how to decide what biological evaluation a device needs within a risk management process |
| ISO 10993-5 | Tests for in vitro cytotoxicity |
| ISO 10993-10 | Tests for skin sensitization |
| ISO 10993-23 | Tests for irritation |
| ISO 10993-11 | Tests for systemic toxicity |
| ISO 10993-12 | Sample preparation and reference materials |
| ISO 10993-18 | Chemical characterization of materials |
This is a representative subset, not the complete series. The specific parts applicable to a given device depend on its contact type, duration, and the biological evaluation plan built for it.
How FDA Uses ISO 10993-1
FDA does not require ISO 10993 testing by regulation, but the agency has issued guidance, most recently updated in September 2023, describing how it expects manufacturers to apply ISO 10993-1's risk-based biological evaluation approach in premarket submissions, including 510(k), PMA, De Novo, IDE, and HDE pathways. FDA also maintains a recognized consensus standards database, searchable by standard and by FDA's Biocompatibility specialty task group area, listing the standards FDA will accept a Declaration of Conformity against. Confirm the currently recognized edition of any ISO 10993 part directly in FDA's database before citing it in a submission.
ISO updated Part 1 in 2025, and FDA has partially recognized the new edition. FDA's biocompatibility guidance remains the agency's stated expectation for premarket submissions. Confirm the current recognition status and any transition dates in FDA's recognized consensus standards database.
Under this risk-based approach, the question is not "has every possible test been run" but "does the biological evaluation plan, built from existing data, chemical characterization, and any testing still needed, add up to reasonable assurance for this device's specific contact type and duration." A device with well-characterized, previously evaluated materials may need little new testing; a device with novel materials or prolonged internal contact typically needs more.
The Biological Evaluation Plan
A biological evaluation plan is the documented rationale, built under the ISO 10993-1 framework, for which biological endpoints a device needs to address and how (through existing data, material chemical characterization, or new testing) before the device's overall biological risk is judged acceptable. It is the organizing document for the biocompatibility section of a submission. Testing that does not trace back to a documented rationale is harder to justify in review.
Planning Biocompatibility Testing for a Submission?
ADB's regulatory team reviews biocompatibility documentation and testing plans against ISO 10993-1 and FDA's recognized-standard expectations as part of the 510(k) Readiness & Gap Assessment.
See 510(k) Gap Assessment Book a Free ConsultFrequently Asked Questions
What is ISO 10993?
ISO 10993 is a multi-part international standard series for the biological evaluation of medical devices. It sets out a risk-based framework for deciding what biological testing, if any, a device needs based on how and how long it contacts the body, rather than requiring the same fixed battery of tests for every device.
Does every device need biocompatibility testing under ISO 10993?
No. ISO 10993-1 describes a risk-based evaluation, not a mandatory test list. A device with well-characterized materials and existing clinical history of use may need little or no new testing, while a device with novel materials or prolonged internal contact typically needs more.
Does FDA require ISO 10993 testing by regulation?
FDA does not mandate ISO 10993 by regulation, but it recognizes parts of the series as consensus standards through its recognized consensus standards database and has issued guidance describing how it expects ISO 10993-1's risk-based framework to be applied in premarket submissions.
What is a biological evaluation plan?
A biological evaluation plan is the documented rationale, built under the ISO 10993-1 framework, for which biological endpoints a specific device needs to address and how (through existing data, chemical characterization, or new testing) before the overall biological risk is judged acceptable.