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ISO 17510:2025

Medical devices — Sleep apnoea breathing therapy — Masks and application accessories

Nov 26, 2025

General information

60.60     Nov 26, 2025

ISO

ISO/TC 121/SC 3

International Standard

11.040.10  

English   French  

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Published

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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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 17510:2015

NOW

PUBLISHED
ISO 17510:2025
60.60 Standard published
Nov 26, 2025

National adoptions

dnaSRPS EN ISO 17510:2024  
ISS

Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO/FDIS 17510:2025)

50.60   Close of voting. Proof returned by secretariat

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