Anaesthesia Equipment - Related International Standards
The following non-harmonised international standards are related to Anaesthesia Equipment for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 80601-2-13:2022 | Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation | active | 14, 14.2 | Link |
| ISO 11197:2019 | Medical supply units | active | 14, 21 | Link |