体外诊断
本类别共 4 条标准。
| 标准编号 | 标题 | 适用范围 | GSPR |
|---|---|---|---|
| ISO 15197:2013 | In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus | Blood glucose monitoring system requirements | 14, 14.1 |
| ISO 18113-1:2022 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements | IVD labeling requirements | 23, 23.1 |
| ISO 15197:2013+AMD1:2024 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus | In vitro diagnostic medical devices -- Requirements for blood-glucose monitoring... | 15, 22 |
| EN ISO 15189:2022 | Medical laboratories - Requirements for quality and competence | Medical laboratories -- Requirements for quality and competence (European adopte... | 15, 15.1 |