ISO 17510:2025
ISO 17510:2025 Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
CDN $337.00
This publication was last reviewed and confirmed in 2025.
Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
Description
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.
Edition
2
Published Date
2026-06-19
Status
PUBLISHED
Pages
36
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 4125:1991 Dry fruits and dried fruits – Definitions and nomenclature
CDN $82.00 Add to cart -
ISO 16443:2014 Dentistry – Vocabulary for dental implants systems and related procedure
CDN $124.00 Add to cart -
ISO 15416:2025 Automatic identification and data capture techniques – Bar code print quality test specification – Linear symbols
CDN $336.00 Add to cart -
ISO 16520:2025 Tourism and related services – Restaurants and catering – Vocabulary
CDN $186.00 Add to cart
