Hivatkozási szám

MSZ EN ISO 80601-2-90:2022

Dokumentumazonosító

178227

Cím

Gyógyászati villamos készülékek. 2-90. rész: Nagy áramlási sebességű légzésterápiás készülékek alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (ISO 80601-2-90:2021)

Angol cím

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)

Alkalmazási terület

Clause 1 of IEC 60601-1:2005+AMD1:2012+AMD2:2020 applies, except as follows: NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020. 201.1.1 *Scope Replacement: This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.220, hereafter also referred to as ME equipment or ME system, in combination with its accessories: — intended for use with patients who can breathe spontaneously; and — intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed. EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation. EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high. EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance. Respiratory high-flow therapy equipment can be intended for use in the home healthcare environment or intended for use in professional healthcare facilities. NOTE 1 In the home healthcare environment, the supply mains is often not reliable. Respiratory high-flow therapy equipment can be: — fully integrated ME equipment; or — a combination of separate items forming a ME system. This standard also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode. NOTE 2 This standard and ISO 80601-2-12[14] are applicable to a critical care ventilator with a high-flow therapy mode. Respiratory high-flow therapy equipment can be transit-operable. This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment. Túl hosszú scope

ICS

11.040.10 Altató-, érzéstelenítő-, lélegeztető- és újraélesztőberendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2022-03-01

Forrás

idt ISO 80601-2-90:2021; idt EN ISO 80601-2-90:2021

Előd

Utód

Módosítás

Kiegészítő információk

SZK-közlemények

Kapcsolódó európai jogszabály

2017/745/EU (MDV17)

A szabvány

kapható formátuma

Papír ,
PDF (letöltés) (a fájl mérete: 2073272) ,

oldalszáma

100 oldal; XB kategória

ára

Nettó: 25750 Ft
Bruttó:
Papír formátum esetén (5% Áfával): 32445 Ft
PDF (letöltés) formátum esetén (27% Áfával): 32703 Ft