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

SS-EN-ISO-80601-2-87 - 2021 EDITION - CURRENT


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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 als...

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Designation Name

SS-EN ISO 80601-2-87:2021

Revision Level

2021 EDITION

Status

Current

Publication Date

May 4, 2021

Language(s)

English

Page Count

148

International Equivalent

EN ISO 80601-2-87:2021(IDT); ISO 80601-2-87:2021(IDT)