DIN EN ISO 10651-2-2011 医用肺通气机.基本安全和性能的特殊要求.第2部分:通气机依赖型患者用家庭保健通气机(ISO 10651-2-2004);德文版EN ISO 10651-

标准号：DIN EN ISO 10651-2-2011
中文标准名称：医用肺通气机.基本安全和性能的特殊要求.第2部分:通气机依赖型患者用家庭保健通气机(ISO 10651-2-2004);德文版EN ISO 10651-2-2009
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); German version EN ISO 10651-2:2009
标准类型：C46
发布日期：1999/12/31 12:00:00
实施日期：2009/8/1 12:00:00
中国标准分类号：C46
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 60097-4;IEC 60601-1-1988;IEC 60601-1-6;IEC 60601-1-2;IEC 60601-1-8-2003
适用范围：IEC 60601-1:1998, Clause 1 applies, except as follows.Amendment:This part of ISO 10651 specifies requirements for lung ventilators intended for home care applications for those patients who are dependent on ventilatory support. Such ventilators are considered life-supporting equipment. These ventilators are frequently used in locations where driving power is not reliable and are often supervised by non-healthcare personnel with different levels of training.