Tissue Engineering - Related International Standards
The following non-harmonised international standards are related to Tissue Engineering for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO/TS 21560:2020 | General requirements of tissue-engineered medical products | active | 1, 3, 5, 10 | Link |
| ISO 13022:2012 | Medical products containing viable human cells - Application of risk management and requirements for processing practices | active | 1, 3, 5, 10 | Link |
| ASTM F2150-19 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products | active | 1, 3, 5, 10 | Link |
| ASTM F2312-24 | Standard Terminology Relating to Tissue Engineered Medical Products | active | 1, 3 | Link |