Standard

ISO/TR 21954:2018 en

Guidance on the selection of the appropriate means of ventilation based on the intended patient, use environment, and operator

132,95 160,87 Incl BTW

About norm

Status Current
Number of pages 40
Committee Anesthesie- en beademingssystemen
Published on 01-07-2018
Language English
ISO/TR 21954 considers and identifies criteria about the intended patient, intended use environment, and intended operator across the spectrum of the types of ventilation-related equipment as listed below: - gas-powered resuscitator as specified in ISO 10651-5[1] 1); - operator-powered resuscitator as specified in ISO 10651-4[2]; - ventilator for critical care as specified in ISO 80601-2-12[3] 2); - ventilator for emergency medical services environment as specified in ISO 80601-2-84[4] 3), the future replacement for ISO 10651-3[5]; NOTE 1 ISO 80601‐2‐84 updates the content of ISO 10651‐3 and harmonizes it with IEC 60601-1:2005+AMD1: 2012[6] and IEC 60601-1-12:2014[7]. - ventilator for ventilatory impairment in the home healthcare environment as specified in ISO 80601-2-79[8]; - ventilator for ventilatory insufficiency in the home healthcare environment as specified in ISO 80601-2-80[9]; - ventilator for ventilator-dependent patients in the home healthcare environment as specified in ISO 80601-2-72[10]; - sleep apnoea breathing therapy equipment as specified in ISO 80601-2-70[11]. This document is intended to provide guidance that can assist manufacturers, authorities having jurisdiction and users in the development, selection and application of different types of ventilatory equipment based on the intended patient, intended use environment and intended operator.

Details

ICS-code 11.040.10
English title Guidance on the selection of the appropriate means of ventilation based on the intended patient, use environment, and operator

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