药械组合
本类别共 2 条标准。
| 标准编号 | 标题 | 适用范围 | GSPR |
|---|---|---|---|
| ISO 11608-1:2022 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems | Needle-based injection systems. | 10, 14, 14.7 |
| ISO 11608-2:2022 | Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles | Needles for injection systems. | 10, 14 |