ISO 18778:2022 呼吸设备 婴儿心肺监测器的基本安全和基本性能的特殊要求

标准编号：ISO 18778:2022

中文名称：呼吸设备 婴儿心肺监测器的基本安全和基本性能的特殊要求

英文名称：Respiratory equipment — Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors

发布日期：2022-06

标准范围

本文件适用于3.10中定义的婴儿心肺监护仪的基本安全性和基本性能，以下也称为ME？设备及其附件:—？旨在用于家庭医疗保健环境；—？旨在供非专业操作员使用；—？旨在监测三岁以下睡眠或休息儿童的心肺参数；和—？旨在供运输操作使用。笔记？婴儿心肺监护仪也可用于专业保健机构。本文件也适用于制造商打算连接到婴儿心肺监护仪的附件，其中这些附件的特性会影响婴儿心肺监护仪的基本安全性或基本性能。例子？探头、电缆分布式报警系统

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

标准预览图