Patient Monitoring - Related International Standards
The following non-harmonised international standards are related to Patient Monitoring for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 60601-2-23:2011 | Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment | active | 14, 14.1 | Link |
| ISO 80601-2-85:2021 | Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeters | active | 14, 14.1 | Link |
| IEC 80601-2-30:2018 | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers | active | 14, 14.1 | Link |
| ISO 80601-2-61:2026 | Medical electrical equipment - Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment | active | 14, 14.1 | Link |
| ISO 80601-2-56:2017+AMD1:2018 | Medical electrical equipment - Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement | active | 14, 14.1 | Link |
| ISO 80601-2-59:2017+AMD1:2018 | Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening | active | 14, 14.1 | Link |
| IEC 60601-1-10:2007+AMD1:2013+AMD2:2020 | Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral standard: Requirements for the development of physiologic closed-loop controllers | active | 14, 17, 22 | Link |