International Standard
ISO 17510:2025
Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
Reference number
ISO 17510:2025
Edition 2
2025-11
© ISO 2026
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Published (Edition 2, 2025)

ISO 17510:2025

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CHF 181
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Abstract

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.

General information

  • Status
     : Published
    Publication date
     : 2025-11
    Stage
    : International Standard published [60.60]
  • Edition
     : 2
    Number of pages
     : 36
  • Technical Committee :
    ISO/TC 121/SC 3
    ICS :
    11.040.10 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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