Respirační přístroje - Zvláštní požadavky na základní bezpečnost a nezbytnou funkčnost přístrojů pro kojenecké kardiorespirační monitory (Norma k přímému použití jako ČSN).
NORMA vydána dne 1.4.2023
Designation standards: ČSN EN ISO 18778
Classification mark: 852114
Catalog number: 516513
Publication date standards: 1.4.2023
The number of pages: 72
Approximate weight : 216 g (0.48 lbs)
Country: Czech technical standard
Kategorie: Technické normy ČSN
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 syste