Neonatal - Related International Standards
The following non-harmonised international standards are related to Neonatal for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 60601-2-19:2020+AMD1:2023 | Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators | active | 14, 14.6 | Link |
| IEC 60601-2-20:2020 | Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators | active | 14, 14.6 | Link |
| IEC 60601-2-21:2020+AMD1:2023 | Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers | active | 14, 14.6 | Link |
| IEC 60601-2-50:2020+AMD1:2023 | Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment | active | 14, 14.6 | Link |