What is BS EN ISO 10993-3:2026 - Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity about?
BS EN ISO 10993-3:2026 provides requirements and guidance for the biological evaluation of medical devices where there is a need to assess potential genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity. It forms part of the BS EN ISO 10993 series for the biological evaluation of medical devices.
The revised edition reflects current practice by moving beyond testing alone and supporting a broader, risk-based evaluation approach. This includes the use of chemical characterization and toxicological risk assessment to support biological safety evaluations.
Who is BS EN ISO 10993-3 - Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity for?
This standard is relevant for organizations involved in the development, assessment and regulatory approval of medical devices, including:
- Medical device manufacturers, from start-ups and SMEs to global organizations.
- Regulatory affairs professionals.
- Quality assurance and risk management teams
- Biological safety, biocompatibility and toxicology specialists.
- Clinical and product development teams.
- Test laboratories, CROs and consultants.
- Notified bodies, approved bodies and regulatory reviewers.
- Academic and research organizations working on medical device innovation.
What does BS EN ISO 10993-3 - Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity cover?
The standard provides guidance on the evaluation of:
- Genotoxicity.
- Carcinogenicity.
- Reproductive toxicity.
- Developmental toxicity.
It also includes:
- The use of chemical characterization to support biological evaluations.
Toxicological risk assessment approaches.
- Updated guidance for follow-up evaluation after positive in vitro genotoxicity findings.
- Annex B, incorporating content previously contained within ISO/TR 10993-33:2015.
Why should you use BS EN ISO 10993-3 - Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity?
Biological evaluation is fundamental to demonstrating medical device safety. This standard helps you align your evaluation strategy with current international practice and regulatory expectations.
It can help you:
- Make informed decisions about when testing is necessary.
- Use chemical characterization data more effectively.
- Apply toxicological risk assessment with greater confidence.
- Address positive in vitro genotoxicity results appropriately.
- Build stronger biological evaluation plans and technical documentation.
- Support risk management and increase trust in your device safety evidence.
What’s changed?
BS EN ISO 10993-3:2026 is the fourth edition of this standard and replaces BS EN ISO 10993-3:2014 and ISO/TR 10993-33:2015. Key changes include:
- A shift from testing-focused activities towards evaluation of biological risk.
Introduction of chemical characterization and toxicological risk assessment approaches.
- Updated guidance for follow-up evaluation after positive in vitro genotoxicity tests.
- Removal of the previous follow-up flowchart.
- Separate clauses covering reproductive toxicity and developmental toxicity.
- Removal of the annex on cellular transformation.
- Integration of ISO/TR 10993-33 into Annex B.