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MSZ EN ISO 80601-2-12:2020

Dokumentumazonosító

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Cím

Gyógyászati villamos készülékek. 2-12. rész: Az intenzív ellátásban használt lélegeztetők alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (ISO 80601-2-12:2020)

Angol cím

Medical electrical equipment. Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020)

Alkalmazási terület

Clause 1 of the general standard applies, except as follows: NOTE The general standard is IEC 60601-1:2005+AMD1:2012. 201.1.1 * Scope Replacement: 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 an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining. NOTE 2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator). NOTE 3 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator. - intended to be operated by a healthcare professional operator; and - intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. A critical care ventilator is not considered to utilize 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. 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 in IEC 60601-1:2005, 7.2.13 and 8.4.1. NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2. This document is not applicable to ME equipment or an ME system operating in a ventilatoroperational mode solely intended for patients who are not dependent on artificial ventilation. NOTE 6 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered lifesustaining. Túl hosszú scope

ICS

11.040.10 Altató-, érzéstelenítő-, lélegeztető- és újraélesztőberendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2020-07-01

A visszavonás napja

2024-04-01

Forrás

idt ISO 80601-2-12:2020; idt EN ISO 80601-2-12:2020

Előd

MSZ EN ISO 80601-2-12:2011

Utód

MSZ EN ISO 80601-2-12:2024

Módosítás

Kiegészítő információk

SZK-közlemények

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