STN EN ISO 80601-2-70
| Name: | STN EN ISO 80601-2-70 |
| Validity: | Valid |
| Number of pages: | 92 |
| Language: |
EN
|
| Paper: | 31,80€ |
| Electronic version |
a) Only read (without ability to print and copy)
28,62€ b) Without ability to print, with ability to copy (printscreen) 31,80€ c) With ability to print and copy (printscreen) 41,34€ |
| Slovak title | Zdravotnícke elektrické prístroje. Časť 2-70: Osobitné požiadavky na základnú bezpečnosť a nevyhnutné prevádzkové vlastnosti prístroja na dýchanie počas spánkového apnoe (ISO 80601-2-70: 2025) |
| English title | Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2025) |
| Release Date: | 01. 04. 2026 |
| Date of withdrawal: | |
| ICS: | 11.040.10 |
| Sorting character/National clasification code | 85 2753 |
| Level of incorporation: | idt EN ISO 80601-2-70:2025, idt ISO 80601-2-70:2025 |
| Official Journal | 03/26 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 80601-2-70:2021-06 (85 2753) |
| Note in Official Journal: | |
| Subject of the standard: | This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions. Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings. This document excludes sleep apnoea breathing therapy equipment intended for use with neonates. This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients ... |
| Preview: | Náhľad normy (PDF) |