02 Sep 2025
Biocompatibility is a cornerstone of medical device safety, with ISO 10993 providing a series of guidance documents for medical device biocompatibility assessments. The first document in the series, ISO 10993-1 (Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process), specifically provides requirements for the biological evaluation of medical devices and was last updated in 2018. With the ISO Technical Committee 194 recently approving a new revision to this standard, it’s important to prepare for significant changes that will reshape how biocompatibility assessments are conducted.
What’s changing?
The updated ISO 10993-1, currently under publication, introduces a more streamlined and risk-based approach to biological safety evaluation and includes the following updates:
- Device contact categorization
- Simplified to four groups: intact skin, intact mucosal membranes, breached or compromised surfaces of internal tissues other than blood, and blood
- Externally communicating medical devices category eliminated
- Exposure duration determination
- Three exposure durations remain: limited (≤24 hours), prolonged (24 hours to 30 days), and long-term (>30 days)
- Body contact of even minimal duration (>1 minute) defaults to one-day exposure duration (exceptions apply)
- Presentation of systemic toxicity
- Evaluations for systemic toxicity should reflect the duration of use
- Requirements for genotoxicity and carcinogenicity evaluation
- Genotoxicity assessment now applies to all devices with prolonged contact (unless intact skin contact only)
- Carcinogenicity evaluation added for devices with long-term mucosal contact
- Omission of material-mediated pyrogenicity (MMP)
- MMP testing remains for devices manufactured with materials of unknown pyrogenic potential
- Other concepts and considerations
- Reasonably foreseeable misuse, bioaccumulation, risk analysis/estimation/evaluation/control, life cycle, biological equivalence
Expected adoption timelines
While the revised ISO 10993-1 enhances clarity and reinforces a risk-based evaluation framework, its adoption will vary by region. In parts of Europe, quick adoption is expected as the revision is recognized as ‘state of the art’. In contrast, adoption may take longer in the United States as the FDA maintains a database (Recognized Consensus Standards: Medical Devices) and can choose to recognize all, part or none of a standard.
Next steps
For manufacturers, navigating these changes will require strategic planning and knowledgeable guidance. Partnering with biocompatibility specialists and regulatory consultants will be essential to ensure compliance with both global and regional standards—ultimately safeguarding patient health and accelerating market access.
To explore how Labcorp can support your biocompatibility strategy, visit labcorp.com/industries/device/biocompatibility