Hivatkozási szám

MSZ EN ISO 80601-2-87:2021

Dokumentumazonosító

177246

Cím

Gyógyászati villamos készülékek. 2-87. rész: Nagyfrekvenciás lélegeztetők alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (ISO 80601-2-87:2021)

Angol cím

Medical electrical equipment. Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators (ISO 80601-2-87:2021)

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 a high-frequency ventilator (HFV) 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. High-frequency ventilators for this environment are considered life-sustaining. NOTE 2 For the purposes of this document, such a high-frequency ventilator can provide transport within a professional healthcare facility (i.e., be a transit-operable ventilator). NOTE 3 A high-frequency ventilator intended for use in transport within a professional healthcare facility is not considered as a ventilator intended for the emergency medical services environment. - intended to be operated by a healthcare professional operator; - intended for those patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; and - capable of providing more than 150 inflations/min. There are three principal designations of HFV: - high-frequency percussive ventilation [HFPV, with a typical HFV frequency of (60 to 1 000) HFV inflations/min]; - high-frequency jet ventilation [HFJV, with a typical HFV frequency of (100 to 1 500) HFV inflations/min]; and - high-frequency oscillatory ventilation [HFOV, with a typical HFV frequency of (180 to 1200) HFV inflations/min and typically having an active expiratory phase]. Additionally, HFV designations can be combined together or with ventilation at rates less than 150 inflations/min. * A high-frequency ventilator is not considered 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 an HFV breathing system, or to a high-frequency ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the high-frequency ventilator. Túl hosszú scope

ICS

11.040.10 Altató-, érzéstelenítő-, lélegeztető- és újraélesztőberendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2021-08-01

Forrás

idt ISO 80601-2-87:2021; idt EN ISO 80601-2-87:2021

Előd

Utód

Módosítás

SZK-közlemények

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