Breathing Gas Pathways - Related International Standards
The following non-harmonised international standards are related to Breathing Gas Pathways for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 80601-2-87:2021 | Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators | active | 14, 14.2 | 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 | 10, 14 | Link |
| ISO 18562-2:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter | active | 10, 14 | Link |
| ISO 18562-3:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances | active | 10, 14 | Link |
| ISO 18562-4:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate | active | 10, 14 | Link |
| ISO 7396-1:2016/Amd 1:2017 | Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum | active | 14, 21 | Link |
| ISO 80601-2-12:2023 | Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators | active | 14, 18, 21 | 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 | 14, 18, 21 | Link |
| ISO 80601-2-67:2026 | Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment | active | 14, 18 | Link |
| ISO 80601-2-69:2026 | Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment | active | 14, 18 | Link |
| ISO 80601-2-70:2025 | Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment | active | 14, 18 | Link |
| ISO 80601-2-74:2026 | Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment | active | 14, 18 | Link |
| ISO 80601-2-79:2024 | Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment | active | 14, 18 | Link |
| ISO 80601-2-84:2023 | Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment | active | 14, 18 | Link |