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