ISO 18778:2005 呼吸设备 婴儿检控 特殊要求
标准编号:ISO 18778:2005
中文名称:呼吸设备 婴儿检控 特殊要求
英文名称:Respiratory equipment — Infant monitors — Particular requirements
发布日期:2005-02
标准范围
ISO 18778:2005规定了用于检测三岁以下正在睡觉或休息的儿童的明显生命威胁事件的监测器的安全和基本性能要求。本国际标准适用于家庭护理应用中使用的设备。这些监测器通常在没有持续专业监督的情况下使用。ISO 18778:2005也适用于附件,例如将监护仪应用于患者所需的探头和电缆。它不适用于医疗设施/机构中使用的监护仪。
ISO 18778:2005 specifies requirements for the safety and essential performance of monitors used to detect apparent life-threatening events in sleeping or resting children under three years of age. This International Standard applies to devices used in home care applications. These monitors are generally used without continual professional supervision.ISO 18778:2005 also applies to the accessories, e.g. probes and cables necessary to apply the monitor to the patient. It does not apply to monitors intended for use in health care facilities/institutions.
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