生物来源材料
本类别共 3 条标准。
| 标准编号 | 标题 | 适用范围 | GSPR |
|---|---|---|---|
| ISO 22442-1:2020 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management | Animal tissue medical devices - Risk management. | 10, 10.4, 12 |
| ISO 22442-2:2020 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling | Animal tissue sourcing and handling. | 10, 10.4, 12 |
| ISO 22442-3:2007+AMD1:2015 | 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 | Virus/TSE inactivation validation. | 10, 10.4, 12 |