標(biāo)準(zhǔn)號(hào)：DIN EN ISO 10651-2-2011
中文標(biāo)準(zhǔn)名稱：醫(yī)用肺通氣機(jī).基本安全和性能的特殊要求.第2部分:通氣機(jī)依賴型患者用家庭保健通氣機(jī)(ISO 10651-2-2004);德文版EN ISO 10651-2-2009
英文標(biāo)準(zhǔn)名稱：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
標(biāo)準(zhǔn)類型：C46
發(fā)布日期：1999/12/31 12:00:00
實(shí)施日期：2009/8/1 12:00:00
中國(guó)標(biāo)準(zhǔn)分類號(hào)：C46
國(guó)際標(biāo)準(zhǔn)分類號(hào)：11.040.10
引用標(biāo)準(zhǔn)：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
適用范圍：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.