Point-of-Care Testing (POCT) - Related International Standards
The following non-harmonised international standards are related to Point-of-Care Testing (POCT) 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 | 1, 3, 5, 14 | Link |
| ISO 15189:2022 | Medical laboratories - Requirements for quality and competence (includes POCT requirements) | active | 1, 3, 5, 14 | 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 | Link |
| ISO 20776-1:2019 | Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases | active | 1, 3, 5 | Link |
| ISO 15189:2022 | Medical laboratories - Requirements for quality and competence | active | 1, 3, 5 | Link |