ISO 10651-2:2004 医用肺换气机 第2部分：家用护理换气机的专用要求

标准编号：ISO 10651-2:2004

中文名称：医用肺换气机 第2部分：家用护理换气机的专用要求

英文名称：Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 2: Home care ventilators for ventilator-dependent patients

发布日期：2004-07

标准范围

ISO 10651-2:2004规定了家用肺呼吸机对依赖呼吸机支持的患者的要求。这类呼吸机被视为生命维持设备，经常用于驱动力不可靠的地方，通常由受过不同培训的非医疗人员监督。ISO 10651-2:2004旨在与通用标准IEC 60601-1:1988结合使用。ISO 10651-2:2004不适用于铁甲和“铁肺”呼吸机。ISO 10651-2:2004不适用于仅用于增强自主呼吸患者通气的呼吸机。ISO 10651-2:2004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 10651-2:2004 specifies requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support. Such ventilators are considered life-supporting equipment, are frequently used in locations where driving power is not reliable, and are often supervised by non-healthcare personnel with different levels of training.ISO 10651-2:2004 is intended to be used in conjunction with the General Standard IEC 60601-1:1988.ISO 10651-2:2004 is not applicable to cuirass and 'iron-lung' ventilators.ISO 10651-2:2004 is not applicable to ventilators intended only to augment the ventilation of spontaneously breathing patients.The requirements of ISO 10651-2:2004 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.

标准预览图