New 2026 edition of EN ISO 10993-3 Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity
📅 Published: 6 August 2026
❓ What is it?
The standard that specifies how to assess whether medical devices can cause genotoxicity (genetic damage), carcinogenicity (cancer), and reproductive and developmental toxicity.
⚡ The most important change:
You used to assess with default testing. Now: chemistry and risk analysis first, tests only if you justify them.
🎯 The 3 fundamental changes:
1️⃣ Chemistry before testing
Chemical characterisation (ISO 10993-18) and risk analysis (ISO 10993-17) are the starting point
2️⃣ Fewer animal tests
No longer mandatory across the board. Only for nanomaterials and special cases
3️⃣ Better clarity
Reproductive and developmental toxicity are now assessed separately, focused on real exposure
🔬 Other new features:
✓ Specific guidance for nanomaterials
✓ Methods for hard-to-detect substances (aldehydes)
✓ Carcinogenicity through non-genotoxic mechanisms
⏰ Deadline: the 2014 edition is withdrawn on 31 March 2027