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BSI BS EN ISO 17510:2025

Medical devices. Sleep apnoea breathing therapy. Masks and application accessories
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BSI BS EN ISO 17510:2025

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

PUBLISH DATE 2026
PAGES 46
BSI BS EN ISO 17510:2025
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.
SDO BSI: British Standards Institution
Document Number ISO 17510
Publication Date Feb. 17, 2026
Language en - English
Page Count 46
Revision Level
Supercedes
Committee CH/121/9
Publish Date Document Id Type View
Dec. 11, 2025 BS EN ISO 17510:2025 Revision
Feb. 19, 2020 BS EN ISO 17510:2020 Revision
Feb. 17, 2026 BS EN ISO 17510:2025 Consolidated