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ISO 17510:2025

Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
26. 11. 2025.

Опште информације

60.60     26. 11. 2025.

ISO

ISO/TC 121/SC 3

Međunarodni standard

11.040.10  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 17510:2015

TRENUTNO

OBJAVLJEN
ISO 17510:2025
60.60 Standard objavljen
26. 11. 2025.

Nacionalna preuzimanja

dnaSRPS EN ISO 17510:2024  
ISS

Medicinska sredstva – Terapija disanja pri zastoju disanja (apneje) za vreme spavanja – Maske i dodatni pribor za primenu

50.60   Završetak postupka odobravanja definitivnog teksta nacrta standarda

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