ISO 17510:2025 ED2

Medical devices - Sleep apnoea breathing therapy - Masks and application accessories ISO 17510:2025 ED2

Publication date:   Nov 26, 2025

Scope

This document specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).
This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient.
The requirements in this document take priority over the requirements in ISO 18190.
This document does not cover oral appliances.
NOTE This document has been prepared to address the relevant essential principles [14] and labelling principles [15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.