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STN EN ISO 80601-2-90

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Electronic version (pdc file)

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Name: STN EN ISO 80601-2-90
Validity: Valid
Number of pages: 102
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 2-90: Osobitné požiadavky na základnú bezpečnosť a nevyhnutné prevádzkové vlastnosti dýchacích prístrojov vysokoprúdovej terapie (ISO 80601-2-90: 2021)
English title Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment (ISO 80601-2-90:2021)
Release Date: 01. 01. 2022
Date of withdrawal:
ICS: 11.040.10
Sorting character/National clasification code 85 2753
Level of incorporation: idt EN ISO 80601-2-90:2021, idt ISO 80601-2-90:2021
Official Journal 12/21
Amendments
Replaced by:
Repleces:
Note in Official Journal:
Subject of the standard: This document applies to the basic safety and essential performance of ventilatory high-flow therapy equipment, as defined in 201.3.204, hereafter also referred to as ME equipment, in combination with its accessories: - intended for use in the home healthcare environment; - intended for use in professional healthcare facilities; - intended for use by a lay operator or a healthcare professional operator; - intended for use with patients who can breathe spontaneously; - intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, including a patient whose upper airway is bypassed; and EXAMPLE 1 Patients with Type 1 Respiratory Failure, which exhibits a reduction in arterial blood oxygenation or patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high.
Preview: Náhľad normy (PDF)