Alcance
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 whoseconditions can be life-threatening and who can require comprehensive care and constantmonitoring 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 aprofessional 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 isnot 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 ventilationincluding 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) HFVinflations/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 than150 inflations/min.* A high-frequency ventilator is not considered a physiologic closed loop-control system unless ituses a physiological patient variable to adjust the ventilation therapy settings.This document is also applicable to those accessories intended by their manufacturer to beconnected to an HFV breathing system, or to a high-frequency ventilator, where the characteristicsof those accessories can affect the basic safety or essential performance of the high-frequencyventilator.If a clause or subclause is specifically intended to be applicable to ME equipment only, or toME 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 withinthe scope of this document are not covered by specific requirements in this document except in7.2.13 and 8.4.1 of IEC 60601-1:2005.NOTE 4 Additional information can be found in 4.2 of IEC 60601-1:2005+AMD1:2012.This document is not applicable to ME equipment that is intended solely to augment theventilation of spontaneously breathing patients within a professional healthcare facility.This document does not specify the requirements for: non-high-frequency ventilators or accessories which provide conventional ventilation for usein critical care environments, which are given in ISO 80601-2-12 [23];.NOTE 5 An HFV can incorporate conventional critical care ventilator operational modes, in which case ISO 80601-2-12 is applicable to those modes. ventilators or accessories intended for anaesthetic applications, which are given inISO 80601-2-13 [24]; ventilators or accessories intended for the emergency medical services environment, which aregiven in ISO 80601-2-84, the replacement for ISO 10651-3 [13];NOTE 6 An HFV can incorporate EMS ventilator capability. ventilators or accessories intended for ventilator-dependent patients in the home healthcareenvironment, which are given in ISO 80601-2-72 [26]; ventilators or accessories intended for home-care ventilatory support devices, which aregiven in ISO 80601-2-79 [2