ISO 10651-6:2004 医用肺换气机-基本安全和基本性能的特殊要求 第6部分:家中照料用通风支持装置
标准编号:ISO 10651-6:2004
中文名称:医用肺换气机-基本安全和基本性能的特殊要求 第6部分:家中照料用通风支持装置
英文名称:Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 6: Home-care ventilatory support devices
发布日期:2004-07
标准范围
ISO 10651-6:2004规定了家庭护理呼吸机支持设备的基本安全和基本性能要求,该设备主要用于家庭护理,但可用于其他地方(如医院),适用于不需要使用符合ISO 10651-2的家庭护理呼吸机的适当患者。本标准拟与通用标准IEC 60601-1:1988结合使用。ISO 10651-6:2004的要求取代或修改了IEC 60601-1:1988及其修正案1(1991)和2(1995)的要求,旨在优先于相应的一般要求。
ISO 10651-6:2004 specifies the basic safety and essential performance requirements for home-care ventilatory support devices, intended mainly for use in home care but which could be used elsewhere (e.g. in hospitals) for appropriate patients for whom the use of a home-care ventilator complying with ISO 10651-2 is not required. It is intended to be used in conjunction with the General Standard IEC 60601-1:1988.The requirements of ISO 10651-6:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.
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