Hivatkozási szám

MSZ EN ISO 80601-2-72:2023

Dokumentumazonosító

182824

Cím

Gyógyászati villamos készülékek. 2-72. rész: Lélegeztetőre kapcsolt páciensek otthoni egészségügyi ellátására szolgáló lélegeztetőjének alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (ISO 80601-2-72:2023)

Angol cím

Medical electrical equipment. Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2023)

Alkalmazási terület

Replacement: NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2. This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment: - intended for use in the home healthcare environment; NOTE 2 In the home healthcare environment, the supply mains driving the ventilator is often not reliable. NOTE 3 Such ventilators can also be used in non-critical care applications of professional healthcare facilities. - intended for use by a lay operator; and - intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. A ventilator is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. EXAMPLE Breathing tubes, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, and distributed alarm system. NOTE 4 If a clause or subclause is specifically intended to be applicable to ME equipment only or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except for the requirements specified in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document does not specify the requirements for: - ventilators or accessories intended for critical care applications, which are given in ISO 80601-2-12; - ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13; - ventilators or accessories intended for emergency and transport which are given in ISO 80601-2-84; - ventilators or accessories intended for homecare ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601-2-79 and ISO 80601-2-80; - obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70; - high-frequency ventilators, which are given in ISO 80601-2-87. - respiratory high-flow therapy equipment, which are given in ISO 80601-2-90; NOTE 6 An ISO 80601-2-72 ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. - user-powered resuscitators, which are given in ISO 10651-4; - gas-powered emergency resuscitators, which are given in ISO 10651-5; - oxygen therapy constant flow ME equipment; and - cuirass and “iron-lung” ventilators.

ICS

11.040.10 Altató-, érzéstelenítő-, lélegeztető- és újraélesztőberendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2023-12-01

Forrás

idt EN ISO 80601-2-72:2023; idt ISO 80601-2-72:2023

Előd

MSZ EN ISO 80601-2-72:2016

Utód

Módosítás

SZK-közlemények

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