標(biāo)準(zhǔn)號(hào)：BS EN ISO 10651-2-2009
中文標(biāo)準(zhǔn)名稱：醫(yī)用肺通氣機(jī).基本安全性和必要性能的詳細(xì)要求.第2部分:通氣機(jī)依賴型患者用家庭護(hù)理通氣機(jī)(ISO 10651-2-2004)
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)
標(biāo)準(zhǔn)類型：C47
發(fā)布日期：2009/7/31 12:00:00
實(shí)施日期：2009/7/31 12:00:00
中國標(biāo)準(zhǔn)分類號(hào)：C47
國際標(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 60079-4;IEC 60601-1-1988;IEC 60601-1-2;IEC 60601-1-6;IEC 60601-1-8-2003
適用范圍：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.