STN EN ISO 17510
| Name: | STN EN ISO 17510 |
| Validity: | Valid |
| Number of pages: | 48 |
| Language: |
EN
|
| Paper: | 18,90€ |
| Electronic version |
a) Only read (without ability to print and copy)
17,01€ b) Without ability to print, with ability to copy (printscreen) 18,90€ c) With ability to print and copy (printscreen) 24,57€ |
| Slovak title | Zdravotnícke pomôcky. Respiračná liečba spánkového apnoe. Masky a používanie doplnkov (ISO 17510: 2025) |
| English title | Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO 17510:2025) |
| Release Date: | 01. 04. 2026 |
| Date of withdrawal: | |
| ICS: | 11.040.10 |
| Sorting character/National clasification code | 85 2102 |
| Level of incorporation: | idt EN ISO 17510:2025, idt ISO 17510:2025 |
| Official Journal | 03/26 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 17510:2020-06 (85 2102) |
| Note in Official Journal: | |
| Subject of the standard: | 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. |
| Preview: | Náhľad normy (PDF) |