SS-EN-ISO-18778 Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors (ISO 18778:2022)

SS-EN-ISO-18778 - 2022 EDITION - CURRENT
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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

To find similar documents by classification:

11.040.10 (Anaesthetic, respiratory and reanimation equipment Including medical gas installations)

11.040.55 (Diagnostic equipment Including medical monitoring equipment, medical thermometers and related materials)

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Designation Name

SS-EN ISO 18778:2022

Revision Level

2022 EDITION

Status

Current

Publication Date

Oct. 26, 2022

Language(s)

English

Page Count

72

International Equivalent

EN ISO 18778:2022(IDT); ISO 18778:2022(IDT)