Biological Materials - Related International Standards
The following non-harmonised international standards are related to Biological Materials for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 22442-1:2020 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management | active | 10, 10.4, 12 | Link |
| ISO 22442-2:2020 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling | active | 10, 10.4, 12 | Link |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents | active | 10, 10.4, 12 | Link |
| ISO 3826-1:2019 | Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers | active | 1, 3, 5, 10, 11 | Link |
| ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components - Part 4: Apheresis blood bag systems with integrated features | active | 1, 3, 5, 10, 11 | Link |
| ISO/TS 21560:2020 | General requirements of tissue-engineered medical products | active | 1, 3, 5, 10 | Link |