CSA C22.2 No. 80601-2-87:23

Medical electrical equipment — Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
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]. ? respiratory high-flow ME equipment, which are given in ISO 80601-2-90:—1; and ? cuirass or “iron-lung” ventilation equipment. This document is a particular standard in the IEC 60601 series, the IEC 80601 series and the ISO 80601 series.
OEN:
CSA
Langue:
English
Code(s) de l'ICS:
11.040.10
Statut:
Norme
Date de Publication:
2023-02-28
Numéro Standard:
CSA C22.2 No. 80601-2-87:23