CSA Z18778:24

CSA Preface This is the second edition of CSA Z18778, Respiratory equipment — Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard, ISO 18778:2022 (second edition, 2022-06). It supersedes the previous edition, published in 2008 as CSA Z18778 (adopted ISO 18778:2005) Respiratory equipment — Infant monitors — Particular requirements. For brevity, this Standard will be referred to as "CSA Z18778" throughout. CSA Group acknowledges that the adoption of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Quebec, Saskatchewan, and Yukon, as administered by Canada’s Drug Agency (CDA-AMC). This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard. This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Perioperative Safety, under the jurisdiction of the CSA Strategic Steering Committee on Health and Well-being, and has been formally approved by the Technical Committee. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories: — intended for use in the home healthcare environment; — intended for use by a lay operator; — intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and — intended for transit-operable use. NOTE An infant cardiorespiratory monitor can also be used in professional health care facilities. This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor. EXAMPLE probes, cables distributed alarm system