Respiratory & Anaesthesia - Related International Standards
The following non-harmonised international standards are related to Respiratory & Anaesthesia for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 4135:2022 | Anaesthetic and respiratory equipment - Vocabulary | active | 1, 3 | Link |
| ISO 80601-2-55:2018+AMD1:2023 | Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors | active | 1, 3, 5, 14 | Link |
| ISO 80601-2-12:2023 | Medical electrical equipment - Part 2-12: Particular requirements for the basic safety and essential performance of critical care ventilators | active | 1, 3, 5, 9, 14 | Link |
| ISO 80601-2-70:2025 | Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment | active | 1, 3, 5, 9, 14 | Link |
| ISO 18562-1:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process | active | 1, 3, 5, 10 | Link |