BS EN ISO 10651-2-2009 医用肺通气机.基本安全性和必要性能的详细要求.第2部分:通气机依赖型患者用家庭护理通气机(ISO 10651-2-2004)

标准号：BS EN ISO 10651-2-2009
中文标准名称：医用肺通气机.基本安全性和必要性能的详细要求.第2部分:通气机依赖型患者用家庭护理通气机(ISO 10651-2-2004)
英文标准名称：Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)
标准类型：C47
发布日期：2009/7/31 12:00:00
实施日期：2009/7/31 12:00:00
中国标准分类号：C47
国际标准分类号：11.040.10
引用标准：ISO 32;ISO 4135;ISO 5356-1;ISO 5356-2;ISO 5359;ISO 5362;ISO 5367;ISO 7396-1;ISO 8185;ISO 9360-1;ISO 9360-2;ISO 9919;ISO 14937;ISO 14971;ISO 15001;ISO 15223-2000;ISO 21647;IEC 60079-4;IEC 60601-1-1988;IEC 60601-1-2;IEC 60601-1-6;IEC 60601-1-8-2003
适用范围：IEC 60601-1:1988, Clause 1 applies, except as follows.Amendment:This part of ISO 10651 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.This part of ISO 10651 is not applicable to cuirass and “iron-lung” ventilators.This part of ISO 10651 is not applicable to ventilators intended only to augment the ventilation of spontaneously breathing patients.The requirements of this part of ISO 10651 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.