ISO/FDIS 17510
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
Hardcopy , PDF
English, French
25-08-2025
26-11-2025
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 ISO18190.
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 AnnexI.
| Committee |
ISO/TC 121/SC 3
|
| DocumentType |
Draft
|
| Pages |
37
|
| PublisherName |
International Organization for Standardization
|
| RevisionOf | |
| Status |
Superseded
|
| Supersedes |
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