In Vitro Diagnostics - Related International Standards
The following non-harmonised international standards are related to In Vitro Diagnostics for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 15197:2013 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus | active | 14, 14.1, 15, 22 | Link |
| ISO 18113-1:2022 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements | active | 23, 23.1 | Link |
| ISO 15189:2022 | Medical laboratories - Requirements for quality and competence | active | 15, 15.1 | Link |