临床调查
本类别共 3 条标准。
| 标准编号 | 标题 | 适用范围 | GSPR |
|---|---|---|---|
| ISO 14155:2020 | Clinical investigation of medical devices for human subjects — Good clinical practice | Clinical investigation requirements | 7 |
| ISO 14155:2020+AMD1:2024 | Clinical investigation of medical devices for human subjects - Good clinical practice | Clinical investigation of medical devices for human subjects -- Good clinical pr... | 1, 6, 8 |
| ISO 20916:2019 | In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice | In vitro diagnostic medical devices -- Clinical performance studies using specim... | 1, 6, 8 |