Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing Within a Risk Management Process
ISO 10993-1:2018 is the cornerstone of the ISO 10993 biocompatibility series. Its fourth edition frames biological evaluation within the ISO 14971 risk-management process rather than as a fixed checklist of tests. It categorises devices by the nature and duration of body contact — surface, external-communicating or implant; limited, prolonged or long-term — and drives selection of biological endpoints such as cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation and haemocompatibility. It emphasises chemical characterisation (ISO 10993-18) and a documented biological evaluation plan and report. FDA recognises the 2018 edition alongside its 2020 guidance on using ISO 10993-1; a further revision (ISO 10993-1:2025) is in development.
What this does not cover
stated in the document's own scope- Part 1 does not contain test methods; the specific procedures live in the other parts of the ISO 10993 series.
- It does not set extractables/leachables toxicological limits directly; chemical characterisation follows ISO 10993-18.
- It does not manage risk on its own — the risk-management process is defined by ISO 14971.
- It does not address sterilization validation, which is covered by ISO 17665 or ISO 11135 depending on method.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
ISO 10993-1:2018 governs the biological evaluation of medical devices — assessing whether a device's materials are safe in contact with the body. The fourth edition made a decisive shift: biological safety is judged through the ISO 14971 risk-management process, using material chemistry and existing knowledge, rather than a mandatory battery of animal tests. It classifies devices by how and how long they contact the body, then guides selection of endpoints such as cytotoxicity, sensitization and systemic toxicity. Part 1 sets the framework; the numbered parts of the series supply the test methods and the chemical-characterisation approach it points to.
Legal basis & how it acquires force
ISO 10993-1 is a voluntary consensus standard given force by regulatory recognition and reference. FDA recognises the 2018 fourth edition as a consensus standard and issued a 2020 guidance on its use in premarket submissions, so biocompatibility evidence is expected to follow it. It is a harmonised standard supporting conformity with the EU Medical Device Regulation (EU) 2017/745, and within a quality system it is invoked through the design-control and risk-management requirements of ISO 13485 and ISO 14971.
Document structure
| Part | Covers |
|---|---|
| Scope and terms | Biological evaluation of medical devices within risk management. |
| General principles | Evaluation as part of the ISO 14971 process. |
| Device categorisation | Nature and duration of body contact. |
| Evaluation and testing | Endpoint-selection framework and the role of existing data. |
| Chemical characterisation | The ISO 10993-18 approach informing toxicological assessment. |
| Biological evaluation plan and report | Documentation of the evaluation and its conclusions. |
Key requirements
- Conduct biological evaluation within the ISO 14971 risk-management process, not as a standalone test list.
- Categorise the device by nature of body contact (surface, external-communicating, implant) and contact duration (limited, prolonged, long-term).
- Identify relevant biological endpoints for the category and justify each included or excluded endpoint.
- Characterise device materials chemically (per ISO 10993-18) and use the data to inform toxicological risk.
- Prepare a biological evaluation plan before testing and a biological evaluation report documenting conclusions.
- Use existing data, literature and equivalence where scientifically justified before generating new animal test data.
- Reassess biological safety when materials, processing, sterilization or clinical use change.
Implementation tips
- Write the biological evaluation plan as a living output of the ISO 14971 risk file so endpoints trace to identified hazards.
- Front-load chemical characterisation under ISO 10993-18; it can justify narrowing biological testing and reduce animal studies.
- Re-open the evaluation whenever a supplier, sterilization method or manufacturing step changes, since each can alter extractables.
International alignment
ISO 10993-1 is maintained by ISO/TC 194 and is tightly coupled to ISO 14971 risk management, which supplies the process it operates inside. FDA recognises the 2018 edition and published a 2020 guidance interpreting its use; it is harmonised under the EU MDR. The wider ISO 10993 series (notably ISO 10993-18 for chemical characterisation) provides the methods Part 1 directs users toward.
ISO 10993-1:2018: frequently asked questions
Quick answers to common questions about ISO 10993-1:2018.
Does ISO 10993-1:2018 require a fixed set of biological tests?
No. The fourth edition drives endpoint selection through a risk-based evaluation, so testing depends on the device's contact category and existing data.
How does ISO 10993-1 relate to ISO 14971?
It requires biological evaluation to be conducted within the ISO 14971 risk-management process; the two are used together.
What role does chemical characterisation play?
Material chemistry (per ISO 10993-18) can identify or rule out toxicological risks and justify limiting new biological testing.
Which edition does FDA recognise?
FDA recognises the 2018 fourth edition and issued a 2020 guidance on using ISO 10993-1 in submissions; a further revision (2025) is in development.