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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


Общая информация 

  • Текущий статус
     : Опубликовано
    Дата публикации
     : 2022-06
  • Версия
     : 2
  • Технический комитет
     : ISO/TC 121/SC 3 Respiratory devices and related equipment used for patient care
  • ICS
     :
    11.040.10 Anaesthetic, respiratory and reanimation equipment
    11.040.55 Diagnostic equipment

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Формат Язык
PDF + ePub
Бумажный
  • CHF187

Жизненный цикл

Цели в области устойчивого развития

Данный стандарт разработан для достижения следующих Цель устойчивого развития

3
Хорошее здоровье и благополучие

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  2. Интернет-магазин
  3. Каталог стандартов
  4. МКС
  5. 11
  6. 11.040
  7. 11.040.10
  8. ISO 18778:2022